Poop Tech, Migraine Glasses & Neural Ice
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Keith Christopher, former FDA reviewer and current Director of U.S. Regulatory Affairs at JNPMEDI, for an appropriately global episode: Keith is calling in at 1 a.m. from Korea, Michael is in Philadelphia for the Project MedTech Startup Symposium, and Allison is in Boston preparing to speak at the MEDevice Conference.
The team dives into a packed week of FDA and MedTech news, starting with three very different De Novo authorizations—the groundbreaking Qoramatic automated stool management kit, Avulux® precision optical filters for migraine-associated light sensitivity, and ReneuRx™ (Neural Ice), an injectable cold-energy therapy for chronic knee osteoarthritis pain. Keith brings his ophthalmic regulatory background to the Avulux® discussion and shares perspective on his current work connecting U.S. regulatory strategy with markets across APAC.
The conversation also covers new PMAs for the BAGUERA®C Cervical Disc Prosthesis and RefluxStop® for GERD, an HDE for OncoSil™ intratumoral treatment for bile duct cancer, and two READI-Home Innovation Challenge technologies designed to move more patient monitoring and care into the home (REMI Neuro Monitoring Home Health Hub and Prapela® Therapeutic Vibrational Crib Mattress).
Additional topics include:
FDA’s first authorization of a wearable continuously monitoring both glucose and ketones
Falling De Novo decision times under MDUFA
Proposed changes to how certain medical device accessories are classified
Digitally derived measures (DDMs) and digital health technologies (DHTs) in clinical investigations
Power morcellation during gynecologic laparoscopic surgeries
New FDA hiring and what it could mean for agency capacity
Why deciphering Federal Register notices sometimes requires its own regulatory strategy
Plus: bird jokes, a surprisingly detailed conversation about “dispoosable” fecal management, debates over what FDA’s new glucose/ketone wearable pathway will turn out to be, and three regulatory professionals admitting they could really use track changes for the Federal Register.
