Sibling Takeover: AI Devices, SNOO & CGMs
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, new PMA approvals, and the growing role of AI and sensor-based technologies in medical devices. Along the way, they share family stories, debate regulatory policy, troubleshoot mysterious audio issues, and prove that terrible jokes may actually be genetic.
The team breaks down two newly approved PMAs, including the VENTANA PTEN companion diagnostic for prostate cancer treatment selection and Saypha® ChiQ™, a dermal filler approved for cheek augmentation. They also discuss the ongoing debate around product jurisdiction and why certain injectable products continue to land in different FDA centers.
Additional topics include:
FDA’s updated AI-Enabled Medical Devices database
Medical Devices that Incorporate Sensor-Based Digital Health Technology
Augmented Reality & Virtual Reality in Medical Devices updates
Medical Device Shortages List updates
FDA READI-Home Innovation Challenge updates and FAQs
New FDA-cleared over-the-counter continuous glucose monitor for children
Home as a Health Care Hub Initiative
FDA and MHRA collaboration efforts
Challenges and opportunities in digital health regulation
Family dynamics, international consulting, and unexpected audio ghosts
Plus: Scandinavian boats, tired bicycles, chilly dogs, the meaning of “plethora,” and why every TTKU episode seems destined to include at least one technical malfunction.
