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
Trump’s Tariffs Threaten to Disrupt Healthcare Supply Chain and Increase Costs
Trump tariffs, medical supply chain, healthcare costs, drug shortages, medical devices, pharmaceutical industry, import taxes
FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025
FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development
Roche Advances Alzheimer’s Disease Diagnosis with Breakthrough Blood Test
Alzheimer’s disease, blood test, Roche, Eli Lilly, FDA breakthrough device designation, pTau217, amyloid pathology, early diagnosis.