Trying to Keep Up

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 spaceA PMA approval for the Synergy Disc®, an expanding cervical disc replacement systemUpdates from MDUFA VI negotiations, including potential improvements to the De Novo processOngoing questions around FDA’s use of AI tools following security concerns and policy shiftsNew and updated FDA guidance and safety communications, including choking response protocolsLinksAI-Enabled Medical DevicesMedical Devices that Incorporate Sensor-Based Digital Health TechnologyAugmented Reality and Virtual Reality in Medical DevicesFDA Update: Choking Rescue ProtocolsConnect Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupMonica Fahrenholtz, PhD | Fahrenholtz Consulting GroupSubscribeSign up to receive a calendar invite for weekly TTKU sessions

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 CoveredCDRH hiring surge and how candidates should apply (hint: LinkedIn > USAJobs)Why De Novo summaries are delayed—and why it matters for strategyAI-enabled imaging and the unexpected PMA pathway (Claire OCT System)Clinical Decision Support (CDS) guidance updates and real-world implicationsFDA’s digital health policy tools and classification challengesLindsey Vonn’s injury: how orthopedic devices enable recoveryRegulatory vs. marketing tension in medtech storytelling Links & Resources MentionedNew PMA: Claire™ OCT Imaging SystemFDA Digital Health Policy NavigatorFDA Guidance: Clinical Decision Support Software ConnectAllison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupMelissa Hall | Statera Regulatory Consulting SubscribeSign up to receive a calendar invite for weekly TTKU sessions

This week on Trying to Keep Up, Allison and Nilo are joined by Véronique Li to unpack a busy week at the FDA.Key TopicsRAPID pathways & reimbursement impactReal-time clinical trials U.S. vs. OUS 510(k) trendsEarly alerts & Class I recallsCybersecurity & SBOM challengesFDA transparency & reclassification updatesLinksRAPID pathway announcement: CMS + FDAReal-time clinical trials (RTCT)MDR coding resourcesAdverse Event Report Data FilesMedical device charging safetyMITRE cybersecurity papersCybersecurity Risk Analysis for Medical Devices in the Era of Evolving Technologies Considerations for Managing Challenges in SBOM Data NormalizationFDA Reclassification databaseFDA Takes Step Forward on Testosterone Therapy for MenConnectAllison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupVéronique Li | ExponentSubscribeSign up to receive a calendar invite for weekly TTKU sessions

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 TopicsDEN250033 De Novo clearance: XplantR explant toolFDA Town Hall insights & prioritiesTAP program & reimbursement challenges (CMS updates)RWE & evolving FDA expectationsMDDT program updatesDigital Health Center of Excellence resourcesUDI system & implications for post-market dataClinicalTrials.gov enforcement & transparency gapsFDA hiring challenges & workforce dynamicsAI in regulatory strategy & upcoming guidanceLinksDe Novo Database (DEN250033)Hjarta XplantR DeviceFDA RST CatalogMDDT ProgramDigital Health Center of ExcellenceCMS NTAP ProposalConnectAllison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupJim Kleinedler, PhD | MedtronicSubscribeSign up to receive a calendar invite for weekly TTKU sessions

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 CoveredDe Novo clearance for Bridge to Life’s perfusion deviceSana Health and emerging light-based therapeuticsBreakthrough vs. STeP vs. TAP: expectations vs. realityTAP Pilot Assessment Report and program implicationsFDA resource constraints and impact on program timelinesReimbursement challenges post-clearanceConference insights: LSI, JPM, CESRAC certification announcements and industry milestonesFDA’s 125th anniversary and agency updatesLinksTAP Pilot Assessment ReportTEMPO Federal Register NoticeStay ConnectedAllison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupSubscribeSign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple Podcasts

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 CoveredRiver Stent System HDE and orphan pathway strategyHDE fundamentals: safety + probable benefit standardPMA Federal Register update and pediatric data expectationsAI in quality systems and validation risksClinicalTrials.gov reporting gaps and compliance challengesFDA trust trends and public perception gapCombination product complexity (device–drug integration)READI Home Innovation Challenge and home-based careNIH HEAL Initiative funding for device researcheMDR system update and usability improvementsExpanded FDA authority request and policy implicationsPost-market vs pre-market regulatory balanceLinksSerenity Medical River™ Stent FDA eMDR Reporting System UpdateFederal Register Notice – PMA Data CollectionFDA Reclassification DatabaseFDA READI Home Innovation ChallengeNIH HEAL InitiativeFDA Commissioner’s Request to CongressStay ConnectedAllison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupHal 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 impactWhen 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 frameworksTEMPO program: timelines, submission variability, and policy implicationsPMA approvals (including AI-enabled breast cancer detection)FDA database limitations: transparency vs. discoveryAEMS (Adverse Event Monitoring System) rollout and implicationsFDA’s internal AI tool (ELSA) and concerns around review transparencyReal-world challenges: reviewer workload, hiring, and infrastructureRegulatory Accelerator and underutilized FDA resources for innovatorsStay Connected:Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupAubrey Shick | Launch and LogicSubscribe:Sign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple Podcasts

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 implicationsNEXUS Aortic Arch Stent Graft PMA: key features and use casesFDA READI Home Innovation Challenge: advancing home-based care technologiesReal-World Evidence (RWE): FDA’s 73 published examples and what they signalTAP Program Expansion: new offices, broader access, and practical impactBreakthrough + TAP dynamics: where programs help and where gaps remainFunding pressure in MedTech: how investor milestones drive premature FDA interactionsWhite Oak 66 venture launch: former FDA leaders shaping early-stage investment strategyEU MDR vs U.S. expectations: leveraging existing clinical data across regionsPost-market vs pre-market shift: industry push toward risk-based regulatory strategiesFDA staffing changes: hiring, attrition, and impact on review timelinesOperational frustrations: delayed summaries, outdated org charts, and transparency gapsLinks:NeuropacsNeuropacs De Novo decision summaryNEXUS Aortic Arch Stent Graft SystemFDA READI Home Innovation ChallengeFDA Real-World Evidence Examples (73 cases)Stay Connected:Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupKristy Katzenmeyer-Pleuss, PhD | KP Medical Device ConsultingSubscribe:Sign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple 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 FDARWE FDA Voices BlogFDA's TAP Program DetailsNeurotech Conference 2026FDA's LinkedInFDA's YouTubeExemptions from Premarket Notification: Class II Medical DevicesReclassification 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 CancerStay Connected:Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupSubscribe:Sign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple Podcasts

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 detectionWhy broad vs. narrow classifications matterPMAs:aura6000™ system for obstructive sleep apneaTrilogy transcatheter heart valve systemBreakthrough devices:MeMed BV Flex™ (bacterial vs. viral test)Noah Labs voice-based heart failure detectionGrowth of home-based diagnostics and telehealth integrationFDA ReDI Conference previewReclassification of melanoma diagnostic devices (Class III → Class II)Benefit-risk considerations across user populationsThe evolving regulatory bar for innovationLinks:NIH – Posting Clinical Trial Informed Consent FormsStay Connected:Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupAlexia Haralambous, MS | Harmonia InsightsSubscribe:Sign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple Podcasts

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 impactShifts in review consistency and timelinesClinical data expectations vs. historical precedentWhere sponsors underestimate regulatory riskHow to use Q-Submissions strategicallyPractical ways to stay ahead of uncertaintyStay Connected:Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupSubscribe:Sign up to receive a calendar invite for weekly TTKU sessionsYouTubeSpotifyApple Podcasts