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 guidance updates, pediatric innovation programs, and one very important question: what exactly is a neurosurgical patty?

They also unpack a fascinating Pennsylvania lawsuit against Character.ai that raises major questions about AI, mental health, and whether chatbots are crossing the line into practicing medicine.

Plus: dad jokes, Guinness commentary, regulatory gossip, and the official TTKU jingle.

Key Topics Covered

• A new De Novo for PTSD treatment using vestibular nerve stimulation

• A new PMA tied to Parvovirus B19 testing during pregnancy

• FDA’s new one-day inspectional assessments

• International surprise inspections

• New orthopedic patient-matched guide guidance

• FDA’s HALO platform and “Elsa 4.0” AI rollout

• Neurosurgical patty supply disruptions

• Pediatric device innovation and consortium programs

• FDA vaccine publication controversy

• Why everyone suddenly wants a shingles vaccine

• eMDR System Enhancements

• Regulatory conference and webinar updates

• MPDC Pediatric Device Showcase: Cardiovascular Focus

• RAPID / SDRAN regulatory talk

• READI home innovation challenge webinar