Right now, the biggest stories for medical device professionals: FDA’s AI and software rules are tightening fast; New rules are reshaping how device evidence gets built; CMS coverage expansion sends TAVR names higher — and 2 more. Real stories, real sources, updated every few hours. Not generated guesses.
AIhigh engagement
FDA’s AI and software rules are tightening fast
A cluster of articles on how AI-enabled devices, regulated eQMS workflows, Annex I cybersecurity evidence, and software classification are being handled under evolving FDA and MDR expectations.
Draft a post from this →regulationmedium engagement
New rules are reshaping how device evidence gets built
Signals about how FDA, UK, EU, and broader regulatory frameworks are shaping statistical methodology, Bayesian trial design, and evidence requirements for diagnostics and other regulated medical technologies.
Draft a post from this →reimbursementhigh engagement
CMS coverage expansion sends TAVR names higher
Multiple signals point to a CMS proposal expanding Medicare coverage for transcatheter aortic valve replacement, driving fresh attention to Edwards Lifesciences and read-throughs for Medtronic and Abbott.
Draft a post from this →manufacturingmedium engagement
Medtech manufacturers race to harden supply and quality
A manufacturing-oriented cluster covering medical silicone tubing, USP Class VI tubing, medical-grade plastics, ISO 13485, sterilization guidance, batch records, and distribution hub buildouts for major medtech firms.
Draft a post from this →accessmedium engagement
Device makers chase access wins across CMS and FDA
Stories about CMS coding approval, VA/DoD access, OTC glucose monitor expansion, CLIA waiver and 510(k) clearance, plus broader commentary on reimbursement and value-based procurement.
Draft a post from this →