Trying to Keep Up

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome Alex Cadotte, former FDA reviewer and current Vice President of Digital Health, AI, and Radiology Regulatory Affairs at MCRA, an IQVIA business, for an in-depth conversation about the rapidly evolving world of AI-enabled medical devices.

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• New draft guidance on substantial evidence for drugs and biologics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

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome two very special guests: Allison’s sister, Erin Gontang, and Michael’s brother, Nick Nilo, for the show’s first-ever sibling edition.

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

This week on Trying to Keep Up, Michael Nilo is flying solo while Allison Komiyama is off galivanting across the pond. Joining him is clinical research and medical device leader Caroline Rhim for a discussion on the current state of clinical trials, emerging technologies, and the evolving regulatory landscape.

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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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA neuroscientist, biochemical engineer, and regulatory consultant Laura Rice, PhD for a fascinating conversation about neurotechnology, brain stimulation, AI-enabled devices, and what it's like to navigate innovation in neuroscience.

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 

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA reviewer and Canon Medical Informatics regulatory leader Jay Vaishnav, PhD, for a deep dive into AI-enabled medical devices, digital pathology, FDA review trends, and the future of software regulation.

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

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA division director and current Director of Medical Affairs at Precision Neuroscience, Vivek Pinto, to talk medical device regulation, innovation, and what FDA reviewers are really thinking during submission review.

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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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by special guest Dave McGurl — regulatory veteran, former FDA reviewer, orthopedic expert, and unofficial “regulatory matchmaker” responsible for introducing Allison and Michael years ago.

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

AI warning letters. Cybersecurity deficiencies. Real-world evidence debates. FDA’s ELSA rollout. This week’s TTKU covered a lot.

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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This week on Trying to Keep Up, Allison and Nilo are joined by Véronique Li to unpack a busy week at the FDA.

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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This week on Trying to Keep Up, Allison and Michael are joined by Jim “SugarJimmy” Kleinedler for a candid conversation on the latest in regulatory affairs.

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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• Sign up to receive a calendar invite for weekly TTKU sessions