Trying to Keep Up

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Hal Stowe to unpack a deceptively busy week at the FDA: HDE pathways, AI misuse in compliance, clinical transparency gaps, and shifting trust in the agency—plus implications for MedTech strategy. 

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

This week on Trying to Keep Up, Allison and Michael are joined by former FDA Digital Health Center of Excellence advisor Aubrey Shick. They unpack what FDA’s latest moves signal for generative AI, digital health policy, and regulatory strategy. From Breakthrough designations for AI-powered recovery tools to TEMPO uncertainty and real-world FDA workflow challenges, this episode blends insider perspective with real-time industry implications—plus a few jokes that hit a little too close to home.

Key Topics Covered

• Digital Health Center of Excellence: role, attrition, and impact
• When software becomes a medical device (and why it’s still unclear)
• Breakthrough designation for RecoveryAI (GenAI in regulated space)
• FDA’s evolving approach to generative AI within existing frameworks
• TEMPO program: timelines, submission variability, and policy implications
• PMA approvals (including AI-enabled breast cancer detection)
• FDA database limitations: transparency vs. discovery
• AEMS (Adverse Event Monitoring System) rollout and implications
• FDA’s internal AI tool (ELSA) and concerns around review transparency
• Real-world challenges: reviewer workload, hiring, and infrastructure
• Regulatory Accelerator and underutilized FDA resources for innovators

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Aubrey Shick | Launch and Logic

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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Kristy Katzenmeyer-Pleuss for a fast-paced discussion on FDA updates, including Neuropacs De Novo, TAP expansion, real-world evidence adoption, and how funding pressure is reshaping regulatory strategy.

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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• YouTube
• Spotify
• Apple Podcasts

This week on Trying to Keep Up, Allison and Michael unpack a busy stretch across the FDA and medtech landscape. From new real-world evidence (RWE) examples and patient preference guidance to hiring insights and TAP program expansion, the conversation blends regulatory updates with practical perspective. They also highlight global innovation and share candid takes on FDA culture, communication, and what it really takes to “keep up.”

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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This week on Trying to Keep Up, Allison and Michael are joined by Alexia Haralambous to break down the latest regulatory activity. They also dive into breakthrough device trends, melanoma device reclassification, and what it all means for innovation, patients, and the future of care at home.

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

When does an AI chatbot become a medical device, and how do you regulate technology that can change the way it responds to patients?

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 and Michael are joined by former FDA leader and regulatory consultant Melissa Hall to break down what’s actually happening inside FDA right now—and what it means for medtech companies trying to navigate it.

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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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory consultant Monica Fahrenholtz, who shares a firsthand account of the unprecedented disruption inside FDA during the past year—from mass layoffs to return-to-office chaos and the ripple effects still being felt across the MedTech ecosystem.

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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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current MDIC NEST leader Jemin Dedania for a fast-moving conversation on FDA reclassification proposals, new AI-enabled devices, real-world evidence, and the latest regulatory headlines.

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

Connect

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

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This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory affairs leader Nicholas Werner for a wide-ranging conversation on FDA updates, global regulatory uncertainty, robotic surgery controversy, and why nobody seems to know what’s happening with harmonization anymore.

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