Medical Devices

Health & Wellness 7 min Four AI Devices Reach Medicare Patients Without Clearance, or a Review Board The FDA's TEMPO pilot sets aside more than marketing authorisation. Enforcement discretion also covers the IDE... AM Amelia Wong 3 Sep Health & Wellness 6 min No Pacemaker Stopped Working. New Patients Cannot Be Enrolled. The reporting says the incident has hit pacemakers. Therapy was never involved and existing monitoring still w... AM Amelia Wong 1 Sep Cybersecurity 7 min Boston Scientific Cannot Ship, and That Is the Emergency A cyber incident took out order processing and shipping worldwide at a maker of pacemakers and stents. Nothing... KE Kenji Tanaka 27 Aug Health & Wellness 6 min J&J Says the FDA Authorised Its OTTAVA Surgical Robot — Almost Nothing in the Announcement Can Be Checked Yet The release never says "nine procedures". Both performance claims cite unpublished internal documentation. And... AM Amelia Wong 26 Jul Health & Wellness 5 min Bayesian Health Wins First FDA Clearance for Continuous AI Sepsis Monitor, Study Shows 18% Mortality Drop Bayesian Health's TREWS system became the first AI device cleared by the FDA to continuously monitor all hospi... AM Amelia Wong 1 Jun Health & Wellness 5 min FDA Clears ArteraAI Breast: The First AI Digital Pathology Tool to Guide Breast Cancer Chemotherapy Decisions On 6 May 2026, Artera's ArteraAI Breast became the first FDA-cleared digital pathology AI tool to stratify ear... AM Amelia Wong 1 Jun