Medical Devices
EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements
EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices
ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use
ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device
Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries
Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices
HR25: LifeSignals launches cardiac monitoring patch to compete with iRhythm, Philips
Preventive monitoring, Plaque (lesion), Philips, Heart, iRhythm, LifeSignals, Medical Devices
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
Ajax Health and KKR Form New Heart Failure Treatment Platform with Boston Scientific Technology
Ajax Health, KKR, Boston Scientific, FlowMod, heart failure treatment, medical device platform
J&J’s Shockwave Medical Launches Novel Javelin Intravascular Lithotripsy Catheter for Treating Calcified Peripheral Artery Disease
Intravascular lithotripsy, peripheral artery disease, calcified lesions, Shockwave Medical, Johnson & Johnson, medical device, vascular intervention
FDA updates Boston Scientific’s Accolade pacemaker recall, reporting 832 injuries
United States Food and Drug Administration, Mental Recall, Preventive monitoring, trauma qualifier, Medical Devices, Artificial cardiac pacemaker
FDA Moves to Rehire Some Recently Fired Employees Amid Backlash
FDA, layoffs, rehiring, Trump administration, medical device industry, public health agencies
Boston Scientific’s Farapulse PFA System Surpasses $1 Billion in Revenue, Transforming Electrophysiology Market
Boston Scientific, Farapulse, pulsed field ablation, atrial fibrillation, electrophysiology, revenue milestone, medical device innovation