Trying to Keep Up

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo catch up on hearing aid software, a CDRH Learn makeover, and draft guidance in a special Halloween Friday edition of Trying to Keep Up. Nilo is a kangaroo. Allison is recovering from conference season. The jokes get dark early.Allison’s discovery of Meta’s July 510(k) clearance kicks off a bigger conversation about hearing aids: more options, different form factors, and why comfort, cost, and appearance can influence whether people actually use them. They trace the hearing aid software pathway back to Apple’s De Novo and discuss the growing overlap between consumer technology and medical devices.Then, something worth celebrating: CDRH Learn is searchable. The hosts applaud the redesign, give Joseph Tartall and the team a shout-out, and have one request: make it easier for newcomers who don’t yet know what to search for.The regulatory discussion continues with:eSTAR for IDEs: The FDA’s draft guidance, the hosts’ mixed feelings about changing submission workflows, and why eSTAR’s embedded guidance and standards links deserve credit.Drug delivery devices: Draft guidance on essential performance characteristics, and why a promising gene therapy still needs a plan to reach the patient.Missing 510(k) summaries: What the hosts noticed while checking recent clearances and why those documents matter when researching predicates.New De Novo: Roche’s Elecsys® HBsAg II quant II RxDx, a companion diagnostic to select and monitor patients with chronic hepatitis B virus (HBV) infection.New Breakthrough Device: Pharaoh Neuro's Neurapheresis™ CSF Management System, designed to remove blood from cerebrospinal fluid following an aneurysmal subarachnoid hemorrhage.Patient education: The FDA’s clear dental aligner webpage and a course on patient-generated and real-world data.Plus: NMCG’s regulatory consultancy award nomination, Nilo’s upcoming trip to MedTech World Malta, and RegulatoryAF updates.Follow Trying to Keep Up for more conversations about the FDA, medical devices, and the questions that don’t come with easy answers. If you’re keeping up with us, rate the show and smash that like button.

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome Michael Owens, MS BME, RAC, a former FDA orthopedic device reviewer and assistant director with nearly 15 years of agency experience. Fresh from The MedTech Conference in Boston, Allison and Owens share insights from conversations with FDA leadership, including updates on Predetermined Change Control Plans (PCCPs), the Safety and Performance Based Pathway, and potential improvements to the De Novo review process. The conversation gets particularly interesting when Owens challenges the group to consider whether PCCPs can work beyond software. Could manufacturers use them to plan material, manufacturing, and compatibility changes before a device even reaches the market? And what happens when those plans reveal future product development strategies to competitors? The team also explores how the FDA can preserve institutional knowledge, reduce reviewer workload, and keep pace with AI-enabled technology. Plus, Nilo shares his firsthand connection to a newly designated Breakthrough Device, and everyone has opinions about using AI to second-guess regulatory experts. Additional topics include:New De Novo: Bioretec’s RemeOs™ Screw LAG Solid, a bioresorbable magnesium-based orthopedic fixation device.New PMA: Vivasure Medical's PerQseal Elite Vascular Closure Device and the importance of rapid hemostasis after large-bore vascular procedures.New Breakthrough Device: Teleflex's Freesolve Resorbable Magnesium Scaffold, including the challenges of developing biodegradable implants.FDA guidance: Regulatory considerations for prescription drug use-related software.PCCP expansion: New FDA examples, authorization statistics, and opportunities for non-software modifications.Safety and Performance Based Pathway: How established performance criteria could simplify substantial equivalence demonstrations.ASCA and real-world evidence: Opportunities to reduce review burdens through accredited testing and stronger evidence programs.TAP and RAPID: Updates on enrollment, review timelines, and efforts to coordinate regulatory authorization with reimbursement planning.De Novo review: Proposed early meetings and non-grantable decisions that could give sponsors more opportunities to address FDA concerns.AI and regulation: Whether regulatory oversight can keep pace with technological change, and why AI-generated feedback can create more work instead of less. Resources discussed:FDA Predetermined Change Control PlansFDA Safety and Performance Based PathwayFDA Guidance: Prescription Drug Use-Related Software

What does it take to go from reviewing medical devices at the FDA to leading a company through PMA approval, fundraising, and commercialization?This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome Shreya Mehta, former FDA cardiovascular device reviewer and current President & CEO of Zenflow, for a candid conversation about the realities of building a medical device company.Shreya traces her journey from engineering and the FDA to Stanford's Biodesign Innovation Fellowship, where the idea for Zenflow began. Twelve years later, the company has secured PMA approval, raised $52 million in Series D funding, and partnered with Cook Medical to bring its technology for benign prostatic hyperplasia (BPH) to more patients.She shares what she's learned about fundraising, managing investor expectations, assembling the right team, and navigating the transition from development to commercialization. The group also discusses why startups need to approach FDA pre-submissions strategically and how regulatory decisions affect business outcomes.Then it's time to catch up on the latest medical device news, including a pediatric heart valve that grows with patients, a new autism diagnostic aid, and three medical innovations recognized by TIME.Additional topics include:FDA to CEO: How regulatory experience helped Shreya build Zenflow and lead the company through PMA approval.Fundraising and commercialization: The emotional intelligence, persistence, and financial discipline required to move from early-stage development to market launch.FDA Q-Subs: Why asking the right questions at the right time matters more than seeking broad feedback.Pediatric devices: Edwards Lifesciences' AUTUS Size-Adjustable Valve, the challenges of pediatric clinical trials, and funding programs that support innovation for children.Autism diagnostics: Argus Cognitive's Neurora and its potential role in supporting earlier autism evaluations.TIME's Best Inventions of 2026: Parcel Health's Tully Tube, Biolinq Shine, and Essilor Stellest.Robotics: The growing role of automated medical procedures, including Vitestro's Aletta blood-draw robot.Real-world evidence: Upcoming FDA Grand Rounds and how RWE could support medical device regulatory decisions.Focused ultrasound: An upcoming FDA workshop exploring neurological and psychiatric applications, including neuromodulation and blood-brain barrier research.RAPID and reimbursement: Whether closer coordination between the FDA and CMS can reduce the gap between regulatory approval and patient access.Global regulatory harmonization: Why navigating multiple regulatory systems remains challenging for medical device companies.Plus: a surprisingly practical conversation about medical devices as holiday gifts.Join Allison, Michael, and Shreya for an inside look at the science, strategy, and persistence behind bringing medical technology to market.

A heart valve designed to expand as a child grows. A ring cleared to measure blood pressure without a cuff. Software that retrains its AI model daily. Allison Komiyama and Michael Nilo unpack a week of device news that raises questions about what innovation can do and how the FDA evaluates it.They start with the Autus Size-Adjustable Valve, a pediatric pulmonary valve that can be widened as a child grows. Then they discuss Happy Health’s cuffless blood pressure ring and ProNova’s VIRTUE QA software, whose authorized predetermined change control plan allows machine-specific AI retraining with automated checks before an updated model goes live.Additional topics include:BridgeSource Medical’s SmartRead device identifier and the cybersecurity questions it raisesThe Juveena Hydrogel System for reducing intrauterine adhesionsEve, a self-balancing exoskeleton designed for hands-free standing and movementMotivista, a digital therapeutic for negative symptoms of schizophreniaBreakthrough Device designations for HeartBeam and SeaStar Medical’s Selective Cytopheretic DeviceThe FDA’s advisory committee nominations, TAP enrollment, and October 19 comment deadline for its generative AI discussion paperThe UK’s work on AI regulation in healthcareThe hosts also share their usual detours, from wearable data and memorable device videos to Halloween jokes and registration for Regulatory AF.

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Tim Marjenin, VP of Neurology Regulatory Affairs at MCRA. Tim spent 16 years at the FDA as a lead reviewer and manager in the neuro group, giving the team plenty to discuss about what happens on both sides of the review process.The conversation starts with a long-awaited update: the FDA finally published the De Novo decision summary for SmartFlow Neuro Cannula after more than two years. The device supports delivery of therapeutics directly into brain tissue, prompting a discussion about neurology, gene therapy delivery systems, and why De Novo decision summaries can take so long to become public.From there, the team digs into one of the increasingly visible issues in medical device submissions: human factors. They discuss the growing scrutiny of usability, the challenges of responding to highly prescriptive deficiencies, and why home-use devices can create especially complex human factors questions.Tim also weighs in on the evolving value of Breakthrough Device Designation. The group discusses whether Breakthrough still delivers meaningful regulatory advantages, how selective review teams have become, and where faster interactions can still make a difference.Additional topics include:The new Liverty™ TIPS Stent Graft PMA and the long road behind PMA productsQ-Sub strategy and why asking the right questions mattersCollaborative FDA review and the value of direct communication with review teamsThe FDA’s FY2027 proposed guidance prioritiesUpcoming guidance for AI-enabled device software and generative AI-enabled conversational devices for mental disordersRobotically assisted surgical devices and increasing levels of autonomyPCCPs, cybersecurity, ASCA, and possible Q-Sub updatesWhy human factors and cybersecurity remain areas every device team should prepare to defendThe FDA’s FY2027 list offers a useful preview of the issues likely to keep regulatory teams busy, and if this episode is any indication, there will be plenty to keep up with.