FDA classifies recall of Boston Scientific device as `most serious`
The Federal Trade Commission is taking a closer look at Boston Scientific’s $3.7 billion proposal to acquire the neuromodulation developer Axonics, a move that could push back the closing of the deal.
WSJ's is the latest media report on a potential bid for Shockwave Medical after Bloomberg News reported last year that Boston Scientific (BSX.N), opens new tab was weighing an offer for the heart device maker.
US FDA approves Boston Scientific's drug-coated heart device
Boston Scientific has received FDA approval for its Agent drug-coated balloon sized to fit within blocked or constricted coronary arteries, nearly a decade after it made its European debut.
Boston Scientific may be shielded from weight-loss drugs hit by procedure recovery
Sept 19 (Reuters) - Medical devices maker Boston Scientific (BSX.N) said on Tuesday it would buy private medical tech company Relievant Medsystems for an upfront cash payment of $850 million, gaining access to an FDA-cleared therapy for chronic pain.
MARLBOROUGH, Mass. and AMSTERDAM, Aug. 27, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE™ Pulsed Field Ablation (PFA) System*, a nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF). The study is the first randomized clinical trial to directly compare the efficacy and safety of the FARAPULSE PFA System against standard-of-care ablation – either radiofrequency or cryoablation – for the treatment of patients with paroxysmal, or intermittent, AF. Findings were presented at ESC Congress 2023, the annual meeting of the European Society of Cardiology, and simultaneously published in The New England Journal of Medicine.
Boston Scientific Corporation announced it has received US Food and Drug Administration (FDA) approval for the POLARx Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.
July 27 (Reuters) - Boston Scientific (BSX.N) raised its annual profit forecast for a second straight quarter on Thursday, banking on resilient demand for its cardiovascular devices as surgical procedure volumes pick up pace.