This week on Trying to Keep Up, Allison and Michael unpack a major De Novo clearance, debate the real value of Breakthrough and STeP designations, and highlight what’s changing across the regulatory landscape.

They cover the Bridge to Life perfusion device milestone, Sana Health’s emerging technology, and the newly released Total Product Lifecycle Advisory Program (TAP) pilot assessment report. The conversation also dives into the growing pressure for companies to pursue Breakthrough status—and whether the regulatory and reimbursement benefits actually deliver.

Plus: conference chatter (LSI, JPM, CES), FDA updates, and a shoutout to new RAC certificants.

If you’re navigating device strategy in 2026, this episode helps you separate signal from noise.

Key Topics Covered

• De Novo clearance for Bridge to Life’s perfusion device
• Sana Health and emerging light-based therapeutics
• Breakthrough vs. STeP vs. TAP: expectations vs. reality
• TAP Pilot Assessment Report and program implications
• 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

Links

• TAP Pilot Assessment Report
• TEMPO Federal Register Notice

Stay Connected

• 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 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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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
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In the first episode of Trying to Keep Up, Michael Nilo and Allison Komiyama unpack the evolving regulatory landscape at the FDA, from workforce disruptions to shifting expectations around clinical data and submission strategy.

They cut through the noise to focus on what impacts medtech teams right now: how review dynamics are changing, where risk is increasing, and how companies can stay proactive instead of reactive.

This is not a scripted podcast. It’s a working conversation between two regulatory professionals trying to keep up in real time.

Key Topics Covered:

• FDA workforce reductions and operational impact
• Shifts in review consistency and timelines
• Clinical data expectations vs. historical precedent
• Where sponsors underestimate regulatory risk
• How to use Q-Submissions strategically
• Practical ways to stay ahead of uncertainty

Stay Connected:

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

Subscribe:

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