The team starts with two new PMAs: Promega’s OncoMate® MSI Dx Analysis System, a companion diagnostic for identifying certain patients with advanced solid tumors who may be eligible for KEYTRUDA®, and MedAlliance’s SELUTION SLR™ 014 PTCA Drug-Eluting Balloon for treating coronary in-stent restenosis. They also cover several recent Breakthrough Device Designations, including the NET Device for stimulant use disorder and VitaSmart HOPE for intestinal transplantation.

Then it’s time for eSTAR. Version 7.1 is here, along with new draft guidance addressing electronic submissions for PMAs. Allison and Michael discuss some of the latest eSTAR changes and what extending the template to PMAs could mean in practice. The group also digs into new draft guidance for robotically assisted surgical devices and an upcoming two-day FDA workshop on benefit-risk considerations for robotic devices with autonomous or remote teleoperation capabilities.

Laura, Allison, and Michael also explore patient engagement and how patient-generated data can influence benefit-risk discussions. Laura shares how her work with the Veterans Health Administration has shown her that different patient populations may have very different tolerances for risk. Michael explains why incorporating patient perspectives into an FDA discussion requires more than finding one patient willing to accept that risk.

Additional topics include:

• New CDRH Learn modules on biocompatibility risk assessment and Medical Device Development Tools
• The Galleri® multi-cancer early detection test advisory committee meeting
• GAO findings on oversight of the FDA’s third-party review program
• 128 new FDA hires and lessons from three former reviewers about learning what regulators have to know versus what is simply nice to know
• ARPA-H’s FASTPASS program and efforts to strengthen healthcare supply chains
• Additive manufacturing, bioprinting, and Laura’s upcoming trip to ASTM ICAM

Plus: a snail with a very long memory, a PCCP joke courtesy of last week’s guest, and the regulatory possibilities of a Roomba knife fight.

Rob breaks down the FDA’s recent Biocompatibility Risk Assessment Town Hall and its approach to ISO 10993-1:2025. The FDA shared examples of when materials and manufacturing information may support biological safety without additional testing. The group also discusses the impact in Europe, where notified bodies are asking companies to assess existing documentation against the updated standard.

Additional topics include:

• FDA’s new CDRH Regulatory Reliance Portal
• Patient voice and risk tolerance in rare disease and pediatric product development
• New FDA leadership appointments
• Why radiology CAD/AI software will continue to require 510(k) review
• An upcoming FDA/MDIC meeting on regulatory science gaps for emerging technologies
• A wearable patch for continuous vancomycin monitoring
• What it means to work across biocompatibility science, engineering, and regulatory affairs

Plus: RAPS observations, birthday cake, and Rob’s FDA-themed standup special.

Links & Resources

• https://content.govdelivery.com/accounts/USFDA/bulletins/4207696
• https://www.fda.gov/medical-devices/cdrh-international-affairs/cdrh-regulatory-reliance-portal-medical-devices
• https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/patient-voice-rare-disease-medical-product-development-10162026
• https://www.hhs.gov/press-room/hhs-announces-key-fda-leadership-selections.html
• https://ascoai.org/articles/2026/04/fda-rejects-bid-for-review-exemption-on-companys-radiology-ai-devices-citing-safety-gaps/
• https://www.fda.gov/medical-devices/medical-devices-news-and-events/regulatory-science-innovations-catalyzing-medical-device-development-09252026

Connect

• Allison Komiyama, PhD, RAC, FRAPS | https://www.linkedin.com/in/allisonkomiyama/
• Michael Nilo, MS | https://www.linkedin.com/in/michaelnilo/
• Rob Allen, PhD | https://www.linkedin.com/in/robert-a-allen-phd-62b37413/

David reflects on nine years at the FDA, including his time in the Office of Legislation helping prepare agency leaders for congressional testimony. He also previews his upcoming RAPS presentation on drug shortages, including efforts to reshore heparin manufacturing and strengthen access to critical medications such as midazolam.

The team digs into Powerful Medical’s Queen of Hearts AI ECG model, which received De Novo authorization for identifying STEMI and STEMI-equivalent patterns in patients with suspected acute coronary syndrome. Unlike many AI tools discussed on TTKU, this one supports time-critical decisions where minutes can matter.

They also celebrate two pediatric device developments: Trexo Robotics’ Theo wearable robotic exoskeleton, which recently received 510(k) clearance after a previous FDA warning letter, and Neola Medical’s Breakthrough Device Designation for a non-invasive continuous lung monitoring system designed for premature infants.

Additional topics include:

• New FDA biocompatibility resources
• Small Business Determination updates
• Updated AI, AR/VR, and digital health device databases
• Clear dental aligner information
• Why some Q-Subs don’t appear in the Customer Collaboration Portal tracker
• Two competing De Novos granted on the same day
• Boston Scientific’s cybersecurity incident
• Annie Saha’s departure after 20+ years at the FDA
• What exactly is happening on the FDA’s Instagram account

Plus: elephant jokes, regulatory nostalgia, and plenty of dad-joke expertise.

Links & Resources: https://nilomed.com/ttku

Connect

• Allison Komiyama, PhD, RAC, FRAPS | https://www.linkedin.com/in/allisonkomiyama/ | https://www.bluestocking.health/
• Michael Nilo, MS | https://www.linkedin.com/in/michaelnilo/ | https://www.nilomedicalconsulting.com/
• David Pudwill | https://www.linkedin.com/in/david-pudwill/ | https://crossject.com/en/ | https://fdablueprint.com/ | https://mrregulatory.com/ | https://pratherbiomedical.com/

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Aubrey Shick, former senior digital health advisor at the FDA’s Digital Health Center of Excellence and founder of Launch and Logic, for a deep dive into generative AI, digital health policy, and how the FDA is approaching technologies that don't always fit neatly into traditional regulatory models.

Aubrey brings a unique perspective to the conversation. Before joining the FDA, she spent more than a decade working in product development and user experience. At the FDA, she helped develop and interpret digital health policy, including work involving generative AI and human-centered AI transparency.

The group looks at RecoveryAI's recent Breakthrough Device Designation for a physician-prescribed, AI-powered assistant designed to support patients recovering from joint replacement. The designation offers an early glimpse into how the FDA may evaluate patient-facing generative AI within existing medical device frameworks.

The conversation also explores the FDA's TEMPO pilot and what its implementation could tell the industry about real-world evidence, enforcement discretion, and emerging digital health policy. Aubrey explains why policy often develops through individual submissions before it appears in formal guidance and why companies working at the edge of existing policy should consider involving the Digital Health Center of Excellence early.

The team also examines the FDA's own growing use of AI. With Elsa reportedly used voluntarily by more than 70% of agency staff, they discuss transparency, data security, model dependency, and whether sponsors should know when AI contributes to a product review.

Additional topics include:

• The FDA's new unified Adverse Event Monitoring System
• Human-centered transparency for patient-facing AI
• The risks and opportunities of generative AI in mental health
• What sponsors should know about TEMPO applications
• How intended use can change a device's regulatory classification
• A new AI-enabled breast cancer imaging PMA
• The FDA's request for feedback on 510(k) submission burden
• CDRH early alerts and device reclassifications
• Digital health resources that innovators may be overlooking
• Why FDA databases provide transparency, but not always discoverability

Plus, Aubrey explains why digital health sometimes comes down to one fundamental question: “Is this a device, or are we all just having a very expensive misunderstanding?”

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Laura Rose, former FDA reviewer and assistant director and current Chief Regulatory Officer at Deffai, to discuss benefit-risk decision-making in medical device regulation.

Laura shares how reviewers approach uncertainty and why experience with technologies that go wrong can make regulators more conservative. She also explains why benefit-risk decisions should consider what happens to patients when new technology isn't available.

The team also examines the Breakthrough Devices Program. With 1,320 designations granted since the program began, what should Breakthrough designation accomplish? Laura and Michael discuss varying evidentiary expectations across FDA offices and whether the program needs a clearer purpose.

They also look at two newly announced Breakthrough devices: Beyond Air®'s LungFit® GO for at-home inhaled nitric oxide therapy and CorTec's fully implantable Brain Interchange™ BCI, which enables computer control through thought alone.

Additional topics include:

• Responding when an FDA request seems unreasonable
• Virtual Incision's MIRA™ Surgical System and its expanded hysterectomy indication
• The FDA's updated position on PFAS in medical devices
• Guidance for dental composite resins and curing lights
• MSDS requests and submission readiness
• The FDA's September 25 regulatory science meeting
• The latest MedSun report
• Horrifying dental X-rays
• Why the right number of dogs may about volume, not quantity

The team dives into a packed week of FDA and MedTech news, starting with three very different De Novo authorizations—the groundbreaking Qoramatic automated stool management kit, Avulux® precision optical filters for migraine-associated light sensitivity, and ReneuRx™ (Neural Ice), an injectable cold-energy therapy for chronic knee osteoarthritis pain. Keith brings his ophthalmic regulatory background to the Avulux® discussion and shares perspective on his current work connecting U.S. regulatory strategy with markets across APAC.

The conversation also covers new PMAs for the BAGUERA®C Cervical Disc Prosthesis and RefluxStop®, an HDE for bile duct cancer treatment OncoSil™, and two READI-Home Innovation Challenge technologies designed to move more patient monitoring and care into the home.

Additional topics include:

• FDA’s first authorization of a wearable continuously monitoring both glucose and ketones
• Falling De Novo decision times under MDUFA
• Proposed changes to classification of certain medical device accessories
• DDMs and DHTs in clinical investigations
• FDA’s collection of allegations of regulatory misconduct
• Power morcellation during gynecologic laparoscopic surgeries

The conversation then turns to the FDA’s new discussion paper on generative AI-enabled medical devices. Rather than issuing formal guidance, the FDA is asking stakeholders to weigh in on some of the hardest questions surrounding GenAI: How should manufacturers evaluate systems with variable or non-deterministic outputs? What should premarket evaluation look like? How should risk and performance be assessed? And where do existing AI/ML regulatory approaches fall short?

The team also digs into the FDA’s unusually active year for device reclassification. Eight reclassifications have already occurred in 2026, compared with 51 entries in the reclassification database since 2013. They discuss why some legacy Class III devices may make more sense as Class II products today and how newer De Novo authorizations can help demonstrate that older classifications deserve another look.

Additional topics include:

• Lower-extremity exoskeletons and their potential uses in healthcare and industry
• FDA’s proposed Class I treatment of certain medical device accessories
• What counts as an “accessory” for blood pressure and ECMO systems
• Why seemingly minor device components can still carry meaningful regulatory risk
• The role of public feedback in shaping FDA’s approach to generative AI
• FDA’s latest commissioner nomination
• What Allison will be speaking about at the MEDevice conference in Boston
• Why robots drawing blood somehow seem less terrifying than robots outrunning humans

The episode opens with a deeper look at CaRi-Heart, Caristo Diagnostics' recently classified AI-powered cardiovascular risk prediction software. Allison and Michael discuss the newly released De Novo classification order, including FDA's use of post-market performance management as a special control and what it could mean for future AI-enabled predictive devices.

The conversation then shifts to FDA and CMS's formally proposed RAPID coverage pathway, examining how earlier coordination between regulators and payers could streamline reimbursement planning for Breakthrough Devices while raising new questions about IDE studies and Medicare enrollment requirements.

The hosts also discuss FDA's updated guidance for over-the-counter medical devices, the growing importance of human factors engineering, and why more companies should be thinking about how their devices can safely migrate from clinical settings into patients' homes. Along the way, they highlight FDA's proposal to down-classify digital breast tomosynthesis (3D mammography), preview the upcoming GRAIL Galleri PMA advisory panel, and spotlight FDA's Patient and Caregiver Connection program as an underutilized resource for incorporating patient perspectives into regulatory decision-making.

Additional topics include:

• RAPID pathway public comment period
• Home Use Devices FAQs
• Regulatory Science Innovations Catalyzing Medical Device Development public meeting, co-sponsored with MDIC
• FY2027 FDA user fees

As always, the conversation mixes practical regulatory strategy with real-world MedTech experience, a healthy appreciation for patient-centered innovation, and enough terrible jokes to keep everyone humble.

Daysi shares her unique perspective on biocompatibility evaluation, ISO 10993 updates, and how risk assessment is evolving beyond simple testing checklists toward a more comprehensive, science-based evaluation of medical devices throughout their entire lifecycle. The discussion also explores where artificial intelligence may fit into toxicological risk assessments and why experienced scientific judgment will remain essential.

The team reviews FDA's newest De Novo authorization for CaRi-Heart, an AI-powered software that predicts long-term cardiovascular outcomes using coronary CT imaging and clinical risk factors, along with a newly approved companion diagnostic PMA for melanoma patients, an emergency use authorization for a monkeypox diagnostic assay, and new AI-powered imaging software for breast ultrasound interpretation.

Additional topics include:

• FDA's recognition of ISO 10993-1:2025 and upcoming biocompatibility town hall
• eSTAR 7.0 and the new Human Factors requirements
• AI-generated 510(k) summaries—and why Allison isn't a fan
• FDA's TEMPO Digital Health pilot expands with HypertensionOS
• AI-powered pathology receives FDA Breakthrough Device Designation
• Companion diagnostics and precision medicine
• Over-the-counter medical device resources
• CDRH's updated Patient and Caregiver Connection program
• The future of preventive medicine, reimbursement, and personalized diagnostics

The conversation explores how regulatory teams are beginning to integrate AI into their daily workflows—from monitoring global regulatory changes to building customized regulatory intelligence tools—while highlighting why experienced regulatory professionals remain essential for strategy, critical thinking, and submission quality.

The team also discusses De Novo authorization for Johnson & Johnson's OTTAVA™ Robotic Surgical System, Freenome’s PMA approval for the SimpleScreen™ CRC blood-based colorectal cancer screening test, FDA's first freeze-dried plasma product, and the potential impact of recent FDA organizational restructuring.

Additional topics include:

• The future of RAPID and FDA/CMS collaboration
• New ISO/DTS 24971-2 guidance for applying ISO 14971 to AI-enabled medical devices
• Why 513(g) requests continue to frustrate regulatory professionals
• Human factors guidance implementation, updated eSTAR requirements, and key takeaways from the July 22 Town Hall
• Medical Device User Fee Rates for FY2027
• Updated List of FDA-Authorized Companion Diagnostic Devices (In Vitro and Imaging Tools)
• New Guidance: Hemodialysis Blood Tubing Sets for 510(k) Submissions
• FDA's modernization of pasteurized orange juice standards
• Updated FAQs for bringing radiation-emitting products to market

Together, they discuss the proposed MDUFA VI changes, including shorter 510(k) review goals, new pre-submission fees, focused follow-up Q-Subs, De Novo introductory meetings, and what these proposals could mean for both reviewers and industry.

The conversation also covers FDA's announcement of the first participant in the TEMPO Digital Health Pilot, newly authorized and breakthrough devices, and the growing role of AI in orthopedics and diagnostics. Mike shares perspectives from more than two decades at FDA, offering insight into how review teams think, why some regulatory programs succeed, and where innovation can sometimes outpace policy. The episode wraps up with a look at emerging home health technologies, including smarter pulse oximeters and passive patient monitoring devices that could reshape care outside the hospital.

Additional topics include:

• Stryker's SportSuite Vision Software De Novo authorization
• TorEx Lung Perfusion System PMA
• Breakthrough Devices for multi-cancer screening and meniscus replacement
• The evolving value of FDA's Breakthrough Devices Program
• FDA's Voluntary Improvement Program (VIP) and Accreditation Scheme for Conformity Assessment (ASCA) initiatives
• Human Factors Town Hall highlights
• AI-enabled surgical navigation and diagnostics
• Home healthcare and passive monitoring technologies

Links

• Kalshi Opens Betting Market for Pharmaceutical Trials and FDA Decisions
• Register for the FDA’s public meeting on MDUFA VI

The conversation covers FDA's newest De Novo authorization for an augmented reality surgical navigation platform, AI-powered diagnostic software receiving Breakthrough Device Designation, and why one ADHD digital therapeutic caught the panel's attention.

The group also takes a deep dive into the FDA's third-party review program, small business fee waivers, FDA recruitment, biocompatibility town halls, non-device software function reporting, why 513(g) requests still aren't anyone's favorite pathway, and whether the Humanitarian Device Exemption (HDE) pathway still works as intended.

Links

• Third Party 510(k) Program: Performance Metrics and Q2 2026 Report
• Small Business Designation (SBD) deadlines
• The FDA Public Health Pillars
• Presentation, Slides, and Transcript from the READI-Home Innovation Challenge Webinar
• Upcoming FDA biocompatibility town halls
  • Biocompatibility Risk Assessment (9/9/26)
  • Biocompatibility and Chemical Characterization Testing – Extractions (9/23/26)
  • Biocompatibility and Toxicological Risk Assessment (10/7/26)

The conversation begins with the newly authorized Claria System, a De Novo-cleared minimally invasive hysterectomy device designed to improve tissue extraction while reducing recovery time and patient risk. Allison explains the history of power morcellation, why containment systems matter, and why this authorization represents an important advancement for women's health technology.

The team discusses the FDA's latest women's health communications surrounding metals detected in tampons and menstrual products, explaining why "detected" does not necessarily mean "dangerous" and how FDA toxicology research helps put alarming headlines into context. They also emphasize Marina Dinekho's thoughtful perspective on risk communication and biocompatibility.

A major topic this week is FDA's proposed Medical Device User Fee Amendments (MDUFA VI), including the possibility of charging user fees for Pre-Submissions, new focused follow-up pre-submission meetings, earlier sponsor interactions for De Novo submissions, and the upcoming public meeting on MDUFA reauthorization. The conversation highlights the value of Pre-Subs, when companies rely on them too heavily, and how these proposed changes could affect future FDA interactions.

Additional topics include:

• MDIC’s best practices for validating medical device cybersecurity through penetration testing
• Updates on FDA's TEMPO pilot and Experiential Learning Program (ELP)
• FDA's increasingly entertaining Instagram food safety campaign
• Early reports on FDA leadership candidates
• Upcoming MedTech conferences and Bluestocking Health's new 2026 conference calendar

As always, the conversation mixes practical regulatory insights with questionable jokes, industry observations, and plenty of side conversations.

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They discuss two newly approved PMAs, including Artivion's hybrid prosthesis for treating acute Type A aortic dissections and LungFX's Centralized Lung Evaluation System, designed to evaluate previously unacceptable donor lungs for transplantation. They also highlight FDA's expanded approval of Casgevy, making the groundbreaking gene therapy available to children as young as two years old with sickle cell disease or transfusion-dependent beta thalassemia.

The conversation also covers:

• FDA's TAP Program now enrolling devices across all OHTs
• eMDR system enhancements and adverse event reporting improvements
• Changes to FDA's Clinical Decision Support Software FAQs following ONC's HTI-1 predictive decision support rule
• Organ preservation technologies and transplantation innovation
• Upcoming RegAF Conference updates

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Alex shares his perspective from both inside FDA and industry on what it takes to bring AI products through regulatory review, why companies still misunderstand Predetermined Change Control Plans (PCCPs), and why FDA's cautious approach to generative AI may actually be exactly what patients need.

The group also discusses one of the first patient-facing large language model (LLM) diabetes management tools, why FDA reviewers sometimes struggle to "let go" of post-market changes, and what companies should consider before investing in a PCCP strategy.

Along the way, they unpack recent De Novo and PMA approvals, cybersecurity expectations, human factors updates, data integrity issues at testing laboratories, and the growing importance of reimbursement planning long before FDA clearance.

As always, there are terrible dad jokes, regulatory tangents, startup war stories, and plenty of honest discussion about where medtech regulation is headed next.

This episode also covers:

• The HepQuant SHUNT® Liver Diagnostic Test PMA
• One of the first patient-facing LLM-enabled diabetes management platforms
• FDA's approach to generative AI-enabled medical devices
• Practical advice for developing AI regulatory strategies
• When PCCPs make sense—and when they don't
• Cybersecurity expectations for modern medical devices
• Human factors considerations for device design
• FDA data integrity notifications and testing laboratory concerns
• New draft guidance on substantial evidence for drugs and biologics
• Breakthrough Device trends and what sponsors should expect
• Why reimbursement strategy should begin before FDA submission

The conversation spans three time zones and two continents as the group discusses the latest FDA developments, digital health initiatives, and the growing role of AI and sensor-based technologies in medical devices. Along the way, they share family stories, debate regulatory policy, and prove that terrible jokes may actually be genetic.

The team breaks down two newly approved PMAs, including the VENTANA PTEN companion diagnostic for prostate cancer treatment selection and Saypha® ChiQ™, a dermal filler approved for cheek augmentation. They also discuss the ongoing debate around product jurisdiction and why certain injectable products continue to land in different FDA centers.

Additional topics include:

• FDA’s SNOO Warning Letter to Happiest Babies
• FDA’s updated AI-Enabled Medical Devices database
• Medical Devices that Incorporate Sensor-Based Digital Health Technology
• Augmented Reality & Virtual Reality in Medical Devices
• Medical Device Shortages List
• FDA READI-Home Innovation Challenge updates & FAQs
• New FDA-cleared over-the-counter continuous glucose monitor for children
• FDA & MHRA collaboration efforts
• Challenges & opportunities in digital health regulation

Michael and Caroline dive into what sponsors are experiencing in today's clinical research environment, from enrollment and site challenges to shifting evidence expectations and the increasing need to align regulatory, clinical, and reimbursement strategies early in development. Drawing on Caroline's experience across MedTech and clinical operations, the discussion focuses on practical lessons for companies trying to move innovative technologies from concept to commercialization.

The episode also covers:

• The current clinical trial landscape and sponsor challenges
• FDA approval of the AbsorbaSeal™ Vascular Closure Device
• SpinaFX's Triojection® IDE approval and breakthrough technologies
• Myopia treatment innovation and emerging clinical evidence
• New FDA draft guidance on communications with payors
• Reimbursement planning and market access strategy
• Human factors guidance updates and the upcoming FDA town hall
• FDA classification orders for newborn screening, SARS-CoV-2 testing, and tinnitus devices
• EUDAMED implementation and MDR certification considerations
• Trends in breakthrough device designations and what they mean for innovators

Plus: cow jokes, clinical trial war stories, regulatory detours, and Michael doing his best to keep the show on the rails while Allison is away.

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Laura shares unique perspective from reviewing neurological & psychiatric devices at FDA, her unexpected departure during the 2025 workforce reductions, and her transition into consulting across neuroscience, software as a medical device (SaMD), diagnostics, & AI. The discussion explores some of the most exciting recent FDA authorizations in neurotechnology, including new non-invasive treatments for PTSD & depression that could expand access to care while reducing treatment burden for patients.

The group also dives into the science behind electrical stimulation therapies, the evolution of neurotechnology from ECT to modern neuromodulation platforms, and how FDA is evaluating increasingly sophisticated neuroscience products.

Key Topics Covered:

• FDA workforce reductions & impact on reviewers
• Neurovalens Modius Spero for PTSD symptoms
• Neurolief Proliv Rx for depression
• Non-invasive brain stimulation tech
• PTSD, anxiety, sleep, & depression treatments
• AI-enabled neurological diagnostics
• Neuropacs & Parkinsonian syndrome diagnostics
• Human factors guidance updates
• Real-world evidence initiatives
• eSTAR updates
• Patient engagement in medical device development

Links

• Webinar: READI-Home Innovation Challenge
• Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, & Similar Entities 

The group unpacks several major FDA authorizations and breakthrough designations, including the DeepView AI® System for burn wound assessment and Cardiosense’s PCWP Analysis Software — a breakthrough AI-enabled heart failure monitoring tool with an approved Predetermined Change Control Plan (PCCP).

Jay shares perspective from both FDA and industry on why AI diagnostics are finally gaining traction, what companies still misunderstand about validation burden, and why PCCP adoption remains surprisingly low despite FDA’s push toward lifecycle-based AI oversight.

The episode also covers:

• FDA’s 50th anniversary of the Medical Device Amendments
• New De Novo authorizations for AI-enabled diagnostics
• AI in digital pathology and cardiovascular monitoring
• PCCPs and why companies struggle to implement them
• Human factors guidance updates and FDA inconsistency frustrations
• MDUFA V performance metrics and sponsor response delays
• ISO 10993-1:2025 recognition updates
• FDA staffing, hiring, and TAP program recruiting
• Leadership turnover at FDA and what it actually means operationally
• Why radiology and cardiology continue leading AI adoption

Plus: giraffe jokes, zebra jokes, crab-cheetah hybrids, office nostalgia, and a surprisingly emotional conversation about FDA reviewers packing up their offices during layoffs.

Links

• FDA Human Factors Website
• FDA Standards Recognition Database
• JAMA Health Forum: Use and Public Reporting of PCCPs for AI-Enabled Medical Devices

Vivek shares stories from his 12+ years at FDA, including his time leading teams in physical medicine and neuromodulation, mentoring reviewers, and helping shape decisions around emerging technologies like brain-computer interfaces (BCIs). The group dives into FDA culture, the realities of balancing risk and access, and why understanding the patient journey matters more than ever.

The episode also covers:

• FDA’s new RAPID pilot program and the future of CMS/FDA collaboration
• Key takeaways from the 2026 REdI Conference
• Why sponsors need to “tell the story” in submissions
• New PMA approvals, including Signatera™ CDx and Atellica IM free PSA II
• FDA’s growing focus on real-world evidence (RWE)
• Patient-focused drug/device development and patient-reported outcomes
• Challenges with the Office of Combination Products (OCP)
• How FDA staff think about benefit-risk and access decisions
• The emotional impact of seeing devices change patients’ lives

Plus: new CDRH Learn modules, updated ELP topics, digital health and TEMPO, and the importance of flexibility and creativity inside FDA.

As always, there are terrible medical jokes, regulatory tangents, and strong opinions about healthcare innovation.

Links

• REdI Conference Speaker Biographies
• ELP Areas of Interest
• Patient Preference Information Guidance
• TEMPO Pilot Module

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The trio dives into a packed week of FDA and medtech news, including leadership shakeups at FDA, new AI initiatives, orthopedic guidance updates, pediatric innovation programs, and one very important question: what exactly is a neurosurgical patty?

They also unpack a fascinating Pennsylvania lawsuit against Character.ai that raises major questions about AI, mental health, and whether chatbots are crossing the line into practicing medicine.

Plus: dad jokes, Guinness commentary, and the official TTKU jingle.

Key Topics Covered

• A new De Novo for PTSD treatment using vestibular nerve stimulation
• A new PMA tied to Parvovirus B19 testing during pregnancy
• FDA’s new one-day inspectional assessments
• International surprise inspections
• New orthopedic patient-matched guide guidance
• FDA’s HALO platform and “Elsa 4.0” AI rollout
• Neurosurgical patty supply disruptions
• FDA vaccine publication controversy
• Why everyone suddenly wants a shingles vaccine
• eMDR System Enhancements
• Regulatory conference and webinar updates
  • MPDC Pediatric Device Showcase: Cardiovascular Focus
  • RAPID / SDRAN regulatory talk
  • READI home innovation challenge webinar

The conversation dives into FDA’s upcoming General Wellness Town Hall, newly released draft guidance on cuffless blood pressure devices, and the ripple effects of recent software guidance changes. Allison and Michael also discuss how medtech startups are navigating tighter budgets, where companies are making risky cost-cutting decisions, and why quality systems still matter even when funding gets thin.

They also recap what they’re hearing from JPMorgan Healthcare Week, reflect on the passing of legendary medtech innovator Thomas Fogarty, and debate whether AI-generated 510(k)s are helping—or creating bigger regulatory problems.

Plus: pirate eye patches, ophthalmology jokes, and FDA social media commentary.

Key Topics Covered

• FDA General Wellness Policy Town Hall
• FDA Draft Guidance: Cuffless Blood Pressure Devices
• Digital health and Software as a Medical Device (SaMD) changes
• Medtech fundraising and JPMorgan Healthcare Conference trends
• Startup quality system risks and regulatory shortcuts
• AI-generated regulatory submissions
• Fraudulent test lab concerns
• Remembering Thomas Fogarty and the Stanford Biodesign legacy
• FDA LinkedIn and Instagram strategy

The trio dives into FDA’s rollout of QMSR, updates to compliance and audit procedures, the launch of the TEMPO Pilot program for digital health technologies, and what recent hiring activity could mean for review timelines and agency capacity. They also unpack the latest MDUFA performance data, PMA publication delays, evolving real-world evidence expectations, and why device-specific guidances may finally be getting more useful.

Along the way, they discuss the new SQUID PMA approval, CDRH Learn updates, eSTAR 6.1 changes, and the growing importance of AI, cybersecurity, and chronic disease technologies at FDA.

Plus: regulatory jokes, dental device trauma, Super Bowl gambling talk, and Allison Komiyama’s accidental lip-filler era.

Key Topics Covered

• FDA QMSR implementation and compliance program updates
• Tempo pilot program for digital health devices
• MDUFA performance metrics and review timelines
• FDA reviewer hiring and return-to-office discussions
• Real-world evidence in De Novos and PMAs
• eSTAR 6.1 updates for De Novo submissions
• Cybersecurity and software guidance updates
• SQUID PMA approval for chronic subdural hematoma treatment
• Device-specific guidance documents and blood pressure device guidance
• CDRH annual report highlights

Links

• Brendan O’Leary MDUFA analysis
• CDRH Learn
• FDA eSTAR Program
• FDA QMSR Resources
• FDA RWE Guidance

They unpack two newly authorized devices making headlines: the Amferia Wound Dressing De Novo and the Optune Pax PMA for pancreatic cancer treatment. Caroline explains how tumor treating fields work, why the technology is so compelling, and what these approvals could signal for the future of medical devices.

The conversation then shifts to one of the biggest topics in medtech right now: FDA Breakthrough Device Designation and TAP. Allison and Caroline discuss what the programs actually help with, where companies get tripped up, investor misconceptions, reimbursement expectations, and why “breakthrough” definitely does not mean “easy.”

They also cover:

• The 2025 CDRH Annual Report
• FDA staffing and communication challenges
• Whether CDRH News is finally back from the dead
• Upcoming Real-World Evidence initiatives
• FDA hierarchy, appeals, and how major regulatory decisions can change at the highest levels
• Bald eagles, hummingbirds, ravens, and aggressively competitive birds of prey

Plus: terrible jokes, medtech optimism, and a surprisingly deep conversation about regulatory nuance.

Key Topics Covered

• Amferia Wound Dressing De Novo
• Optune Pax PMA for pancreatic cancer
• Tumor Treating Fields technology
• FDA Breakthrough Device Designation
• TAP (Total Product Life Cycle Advisory Program)
• Reimbursement and investor expectations
• FDA appeals and hierarchy
• 2025 CDRH Annual Report
• CDRH News revival
• Real-World Evidence Town Hall
• General Wellness guidance updates

The episode starts exactly where you’d expect: terrible jokes, awkward livestream energy, and an unforgettable discussion about the now-infamous RFK Jr./Kid Rock HHS video. From there, the team dives into several notable FDA approvals and clearances, including Optune Pax for pancreatic cancer treatment, the LimiFlex Dynamic Sagittal Tether as a spinal fusion alternative, and newly approved orthokeratology lenses designed to reshape the eye overnight.

Nick also shares insights from the ophthalmic device world, including the growing conversation around myopia control and how FDA’s approach differs globally.

The conversation then shifts into some of the biggest regulatory debates happening right now:

• Intuitive Surgical’s controversial new 510(k)
• Real-world evidence guidance becoming officially active
• Questions around QMSR expectations for IDE studies
• FDA down-classification discussions
• MHRA’s decision to indefinitely recognize CE-marked devices
• Proposed MDR amendments in Europe
• The potential impact of Melissa Torres leaving FDA on global harmonization efforts

As always, the team balances serious regulatory discussion with plenty of chaos, sarcasm, and stories about daycare illnesses, pirates wearing eye patches, and whether hamster balls could solve pediatric infection control.

Key Topics Covered

• FDA PMA approvals: Optune Pax and LimiFlex
• Orthokeratology lenses and myopia control
• Antimicrobial wound dressing De Novo classification
• Intuitive Surgical’s new robotic surgery 510(k)
• FDA real-world evidence guidance rollout
• QMSR expectations for IDE clinical trials
• FDA device down-classification discussions
• MHRA recognition of CE-marked devices
• MDR amendment proposals in Europe
• Melissa Torres leaving FDA and harmonization concerns
• Moderna vaccine review reversal
• Why CDRH Learn returning matters to industry

The group breaks down a newly cleared AI pregnancy timing tool, a PMA approval for the Allurion Gastric Balloon System, and what FDA’s proposed down-classification list could mean for orthopedic, spinal, dental, and surgical device manufacturers. They also discuss emergency use authorizations, rare disease initiatives, digital health leadership changes, and why regulatory precedent matters more than most startups realize.

Plus: bad doctor jokes, cow jokes, and a surprising amount of discussion about medical lube classifications.

Key Topics Covered

• Delivery Date AI De Novo clearance
• Allurion Gastric Balloon System PMA approval
• GLP-1 drugs vs. medical device weight-loss technologies
• FDA proposed down-classification and exemption updates
• Orthopedic and spinal instrument regulatory strategy
• Real-world evidence and MDIC NEST initiatives
• Digital health leadership changes at FDA
• Emergency use authorizations and respiratory testing
• FDA framework for ultra-rare disease therapies
• Why regulatory intelligence matters for startups

Links & Resources Mentioned

• FDA Reclassification Database
• Federal Register Notice: Medical Device Exemptions
• FDA Framework for Ultra-Rare Diseases

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• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Jemin Dedania | MDIC NEST

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Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current precision medicine regulatory expert Josh Levin to unpack the latest developments across medical devices, diagnostics, AI, and regulatory policy.

The team dives into FDA’s newest De Novo authorizations, including the AurieSystem reusable catheter platform and a home HPV collection device designed to expand access to cervical cancer screening.

Josh shares insights from the latest AMDM meeting, including why FDA reviewers are repeatedly flagging “cybersecurity, cybersecurity, cybersecurity” as a major issue for IVD companies. The group also discusses MDIC’s latest work around real-world evidence, pediatric device development, and the ongoing challenge of balancing innovation with data quality expectations.

Other topics include:

• FDA’s new ELSA 4.0 AI rollout
• HALO platform consolidation
• QMSR inspection growing pains
• FDA’s one-day inspection pilot
• Precision medicine & companion diagnostics
• Why FDA hiring restrictions may hurt reviewer recruitment
• ELP program applications reopening
• New guidance on patient-matched orthopedic implant guides

Links

• FDA ELSA 4.0 Announcement
• FDA eSTAR Program Update (new FAQs)
• FDA One-Day Inspection Pilot
• FDA Guidance: Patient-Matched Guides for Orthopedic Implants

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Josh Levin | IronLine Consulting, GSK

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Monica walks through what it was actually like inside FDA during the “Valentine’s Day massacre,” including abrupt terminations, communication breakdowns, and how review teams continued hitting regulatory deadlines despite extreme instability. The conversation highlights the resilience of FDA reviewers and the operational risks companies should still be planning for today.

The team also breaks down key regulatory updates:

• A new De Novo clearance for LifeVac, an anti-choking device now formally entering the regulated space
• A PMA approval for the Synergy Disc®, an expanding cervical disc replacement system
• Updates from MDUFA VI negotiations, including potential improvements to the De Novo process
• Ongoing questions around FDA’s use of AI tools following security concerns and policy shifts
• New and updated FDA guidance and safety communications, including choking response protocols

Links

• AI-Enabled Medical Devices
• Medical Devices that Incorporate Sensor-Based Digital Health Technology
• Augmented Reality and Virtual Reality in Medical Devices
• FDA Update: Choking Rescue Protocols

Connect 

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Monica Fahrenholtz, PhD | Fahrenholtz Consulting Group

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From a surge in CDRH hiring to delays in De Novo summaries, the team unpacks how regulatory realities are evolving in real time. They also dive into a surprising PMA approval for an AI-enabled breast imaging system and what it reveals about inconsistency in classification decisions.

Plus: a deep (and slightly gruesome) look at Lindsey Vonn’s injury and recovery highlights the real-world impact of orthopedic devices—from external fixation systems to plates, screws, and ligament reconstruction technologies that make modern recovery possible.

As always, the conversation blends practical regulatory insight with candid commentary—and a few terrible jokes.

Key Topics Covered

• CDRH hiring surge and how candidates should apply (hint: LinkedIn > USAJobs)
• Why De Novo summaries are delayed—and why it matters for strategy
• AI-enabled imaging and the unexpected PMA pathway (Claire OCT System)
• Clinical Decision Support (CDS) guidance updates and real-world implications
• FDA’s digital health policy tools and classification challenges
• Lindsey Vonn’s injury: how orthopedic devices enable recovery
• Regulatory vs. marketing tension in medtech storytelling

Links & Resources Mentioned

• New PMA: Claire™ OCT Imaging System
• FDA Digital Health Policy Navigator
• FDA Guidance: Clinical Decision Support Software

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Melissa Hall | Statera Regulatory Consulting

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Key Topics

• RAPID pathways & reimbursement impact
• Real-time clinical trials
• U.S. vs. OUS 510(k) trends
• Early alerts & Class I recalls
• Cybersecurity & SBOM challenges
• FDA transparency & reclassification updates

Links

• RAPID pathway announcement: CMS + FDA
• Real-time clinical trials (RTCT)
• MDR coding resources
  • Adverse Event Report
  • Data Files
• Medical device charging safety
• MITRE cybersecurity papers
  • Cybersecurity Risk Analysis for Medical Devices in the Era of Evolving Technologies
  • Considerations for Managing Challenges in SBOM Data Normalization
• FDA Reclassification database
• FDA Takes Step Forward on Testosterone Therapy for Men

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Véronique Li | Exponent

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They break down a newly cleared De Novo device, unpack takeaways from the FDA Town Hall in Minneapolis, and dive into real-world challenges—from transparency and testing expectations to hiring struggles at the FDA. Along the way, they explore evolving programs like TAP, MDDT, and digital health initiatives, plus what recent enforcement around ClinicalTrials.gov means for industry.

Key Topics

• DEN250033 De Novo clearance: XplantR explant tool
• FDA Town Hall insights & priorities
• TAP program & reimbursement challenges (CMS updates)
• RWE & evolving FDA expectations
• MDDT program updates
• Digital Health Center of Excellence resources
• UDI system & implications for post-market data
• ClinicalTrials.gov enforcement & transparency gaps
• FDA hiring challenges & workforce dynamics
• AI in regulatory strategy & upcoming guidance

Links

• De Novo Database (DEN250033)
• Hjarta XplantR Device
• FDA RST Catalog
• MDDT Program
• Digital Health Center of Excellence
• CMS NTAP Proposal

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Jim Kleinedler, PhD | Medtronic

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In this episode of Trying to Keep Up (TTKU), Allison Komiyama and Michael Nilo unpack the growing industry focus on FDA programs like Breakthrough Devices, STeP, and TAP. They discuss why companies are pursuing these pathways so aggressively, what these programs offer, and how perception, investor pressure, commercialization strategy, and regulatory reality all intersect.

They also cover early-year medtech updates, industry conversations coming out of JPM Week, new approvals making headlines, and the increasing pressure companies feel to stand out in a crowded market.

As always, TTKU blends practical regulatory insight with candid industry commentary, side conversations, jokes, and the kind of anti-doom-scroll discussion that helps medtech teams keep up with what actually matters.

Key Topics Covered

• De Novo clearance for Bridge to Life’s perfusion device
• Sana Health and emerging light-based therapeutics
• Why everyone suddenly wants Breakthrough designation
• The growing interest in STeP and TAP programs
• What the FDA TAP Pilot Assessment report reveals
• FDA resource constraints and impact on program timelines
• Reimbursement challenges post-clearance
• Conference insights: LSI, JPM, CES
• RAC certification announcements and industry milestones
• FDA’s 125th anniversary and agency updates

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group

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Key Topics Covered

• River Stent System HDE and orphan pathway strategy
• HDE fundamentals: safety + probable benefit standard
• PMA Federal Register update and pediatric data expectations
• AI in quality systems and validation risks
• ClinicalTrials.gov reporting gaps and compliance challenges
• FDA trust trends and public perception gap
• Combination product complexity (device–drug integration)
• READI Home Innovation Challenge and home-based care
• NIH HEAL Initiative funding for device research
• eMDR system update and usability improvements
• Expanded FDA authority request and policy implications
• Post-market vs pre-market regulatory balance

Links

• Serenity Medical River™ Stent
• FDA eMDR Reporting System Update
• Federal Register Notice – PMA Data Collection
• FDA Reclassification Database
• FDA READI Home Innovation Challenge
• NIH HEAL Initiative
• FDA Commissioner’s Request to Congress

Stay Connected

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Hal Stowe | Eurofins Biopharma Services

Key Topics Covered:

• Neuropacs De Novo: AI-driven Parkinsonian diagnostic and its clinical implications
• NEXUS Aortic Arch Stent Graft PMA: key features and use cases
• FDA READI Home Innovation Challenge: advancing home-based care technologies
• Real-World Evidence (RWE): FDA’s 73 published examples and what they signal
• TAP Program Expansion: new offices, broader access, and practical impact
• Breakthrough + TAP dynamics: where programs help and where gaps remain
• Funding pressure in MedTech: how investor milestones drive premature FDA interactions
• White Oak 66 venture launch: former FDA leaders shaping early-stage investment strategy
• EU MDR vs U.S. expectations: leveraging existing clinical data across regions
• Post-market vs pre-market shift: industry push toward risk-based regulatory strategies
• FDA staffing changes: hiring, attrition, and impact on review timelines
• Operational frustrations: delayed summaries, outdated org charts, and transparency gaps

Links:

• Neuropacs
• Neuropacs De Novo decision summary
• NEXUS Aortic Arch Stent Graft System
• FDA READI Home Innovation Challenge
• FDA Real-World Evidence Examples (73 cases)

Stay Connected:

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Kristy Katzenmeyer-Pleuss, PhD | KP Medical Device Consulting

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• Sign up to receive a calendar invite for weekly TTKU sessions
• YouTube
• Spotify
• Apple Podcasts

Links:

• OxyCare Uganda (Children’s Prize winner)
• FDA ReDI Conference (May 19-20, 2026)
• Real-World Evidence at FDA
• RWE FDA Voices Blog
• FDA's TAP Program Details
• Neurotech Conference 2026
• FDA's LinkedIn
• FDA's YouTube
• Exemptions from Premarket Notification: Class II Medical Devices
• Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group

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Key Topics Covered:

• De Novo clearance: TytoCare Insights for eardrum bulging detection
• Why broad vs. narrow classifications matter
• PMAs:
  • aura6000™ system for obstructive sleep apnea
  • Trilogy transcatheter heart valve system
• Breakthrough devices:
  • MeMed BV Flex™ (bacterial vs. viral test)
  • Noah Labs voice-based heart failure detection
• Growth of home-based diagnostics and telehealth integration
• FDA ReDI Conference preview
• Reclassification of melanoma diagnostic devices (Class III → Class II)
• Benefit-risk considerations across user populations
• The evolving regulatory bar for innovation

Links:

• NIH – Posting Clinical Trial Informed Consent Forms

Stay Connected:

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Alexia Haralambous, MS | Harmonia Insights

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• Sign up to receive a calendar invite for weekly TTKU sessions
• YouTube
• Spotify
• Apple Podcasts

Allison Komiyama and Michael Nilo kick things off by diving into the FDA news, guidance changes, and medtech industry shifts already making waves in 2026. The conversation explores what regulatory and clinical teams should actually pay attention to—without spiraling into doomscroll mode.

As always, the goal is simple: help medtech teams stay informed without losing their minds.

Plus: jokes about aging, running for five straight days, and throwing your back out reaching for toilet paper.

Key Topics Covered

• Infection Control Branch confusion and changes
• CDS Guidance updates
• General Wellness Guidance updates
• Removal of the SaMD guidance
• TEMPO / ACCESS initiatives
• FDA reviewer performance impacts
• Last-minute labeling change requests
• Early 2026 FDA and medtech trends
• Recent approvals since January 1
• Remembering Mike Fogarty

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group

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