Trying to Keep Up

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo dive into another busy week in medical device regulation, highlighting new FDA activity affecting sponsors, startups, and regulatory professionals.   The conversation begins with the newly authorized Claria System , a De Novo-cleared minimally invasive hysterectomy device designed to improve tissue extraction while reducing recover...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo celebrate a holiday-week edition of the podcast while unpacking several important developments affecting medical device and biotechnology companies.   They discuss two newly approved PMAs, including Artivion's hybrid prosthesis for treating acute Type A aortic dissections and LungFX's Centralized Lung Evaluation System, designed to...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo welcome Alex Cadotte , former FDA reviewer and current Vice President of Digital Health, AI, and Radiology Regulatory Affairs at MCRA, an IQVIA business , for an in-depth conversation about the rapidly evolving world of AI-enabled medical devices.   Alex shares his perspective from both inside FDA and industry on what it takes to b...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo welcome two very special guests: Allison’s sister, Erin Gontang , and Michael’s brother, Nick Nilo , for the show’s first-ever sibling edition.   The conversation spans three time zones and two continents as the group discusses the latest FDA developments, digital health initiatives, and the growing role of AI and sensor-based tech...

This week on Trying to Keep Up , Michael Nilo is flying solo while Allison Komiyama is off galivanting across the pond. Joining him is clinical research and medical device leader Caroline Rhim for a discussion on the current state of clinical trials, emerging technologies, and the evolving regulatory landscape.   Michael and Caroline dive into what sponsors are experiencing in today's clinical res...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by former FDA neuroscientist, biochemical engineer, and regulatory consultant Laura Rice, PhD for a fascinating conversation about neurotechnology, brain stimulation, AI-enabled devices, and what it's like to navigate innovation in neuroscience.   Laura shares unique perspective from reviewing neurological & psychiat...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by former FDA reviewer and Canon Medical Informatics regulatory leader Jay Vaishnav, PhD , for a deep dive into AI-enabled medical devices, digital pathology, FDA review trends, and the future of software regulation.   The group unpacks several major FDA authorizations and breakthrough designations, including the DeepVie...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by former FDA division director and current Director of Medical Affairs at Precision Neuroscience , Vivek Pinto , to talk medical device regulation, innovation, and what FDA reviewers are really thinking during submission review.   Vivek shares stories from his 12+ years at FDA, including his time leading teams in physic...

This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by special guest Dave McGurl — regulatory veteran, former FDA reviewer, orthopedic expert, and unofficial “regulatory matchmaker” responsible for introducing Allison and Michael years ago.   The trio dives into a packed week of FDA and medtech news, including leadership shakeups at FDA, new AI initiatives, orthopedic gui...

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 chang...

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...

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...

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...

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 Ba...

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 au...

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...

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...

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 t...

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 explo...

Everywhere you look in medtech right now, companies are talking about Breakthrough, STeP, or TAP. But are these programs changing outcomes or just becoming the industry’s newest obsession?   In this episode of Trying to Keep Up (TTKU), Allison Komiyama and Michael Nilo unpack the growing industry focus on FDA programs like Breakthrough Devices, STeP, and TAP. They discuss why companies are pursuin...

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...

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 pers...

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...

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, an...

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. narro...