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 Balloon System, and what FDA’s proposed down-classification list could mean for orthopedic, spinal, dental, and surgical device manufacturers. They also discuss emergency use authorizations, rare disease initiatives, digital health leadership changes, and why regulatory precedent matters more than most startups realize.

Plus: bad doctor jokes, cow jokes, and a surprising amount of discussion about medical lube classifications.

Key Topics Covered

• Delivery Date AI De Novo clearance

• Allurion Gastric Balloon System PMA approval

• GLP-1 drugs vs. medical device weight-loss technologies

• FDA proposed down-classification and exemption updates

• Orthopedic and spinal instrument regulatory strategy

• Real-world evidence and MDIC NEST initiatives

• Digital health leadership changes at FDA

• Emergency use authorizations and respiratory testing

• FDA framework for ultra-rare disease therapies

• Why regulatory intelligence matters for startups

Links

• FDA Reclassification Database

• Federal Register Notice: Medical Device Exemptions

• FDA Framework for Ultra-Rare Diseases