This week on Trying to Keep Up, Allison Komiyama and Michael Nilo unpack the latest FDA digital health developments, startup funding realities, and the growing uncertainty around general wellness policy.

The conversation dives into FDA’s upcoming General Wellness Town Hall, newly released draft guidance on cuffless blood pressure devices, and the ripple effects of recent software guidance changes.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• FDA Draft Guidance: Cuffless Blood Pressure Devices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

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory strategist and former FDA reviewer Allison Kumar to unpack the FDA news dump nobody had time to read.

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

Michael Nilo is out this week, but the show must go on. Allison Komiyama welcomes longtime FDA colleague and regulatory strategist Caroline Rhim for a fast-moving conversation on breakthrough devices, FDA review realities, new cancer technologies, and the return of CDRH News.

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

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

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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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 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 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 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