The FDA has greenlit an expanded indication for the WaveWriter Alpha spinal cord stimulator systems from Boston Scientific . The approval now includes the treatment of painful diabetic peripheral neuropathy, a diabetes complication affecting the lower extremities. Diabetic neuropathy, a form of nerve damage often found in the legs and feet, is caused by prolonged […]
Boston Scientific
Report: Boston Scientific to open first China factory in Shanghai
According to reports, U.S.-based medtech company Boston Scientific says it intends to open its first factory in China. Reuters reported that Boston Scientific shared the news in a statement on its WeChat social media account. The report said the company shared its interest in expanding regional production in supply chains. Its factory will be in […]
Boston Scientific launches next-gen insertable cardiac monitor
Boston Scientific announced today that it launched its next-generation LUX-Dx II+ insertable cardiac monitor (ICM) system. The system offers long-term monitoring for arrhythmias associated with conditions such as AFib, cryptogenic stroke and syncope. Insertable cardiac monitors are a competitive space. Abbott won FDA clearance in May for its Assert-IQ ICM, while Medtronic continues to release […]
Boston Scientific wins FDA nod for intravascular ultrasound system
Boston Scientific announced today that the FDA cleared its Avvigo+ multi-modality guidance system. The next-generation system provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures. Boston Scientific’s PCI business continues to […]
Boston Scientific completes enrollment in next-gen aortic valve registry
Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment. The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across […]
Boston Scientific targets M&A, AI to reach ‘next level’
Mike Mahoney uses fantasy football to describe Boston Scientific : He says that, if creating a medtech team, “it would be the draft you want.” Speaking at the company’s 2023 Investor Day event, the CEO set the theme as “next level.” He explained his aim to make Boston Scientific a “compelling” and “fantastic place to […]
Boston Scientific to acquire nerve ablation tech developer Relievant Medsystems for $850M
Boston Scientific announced today that it entered into a definitive agreement to acquire Relievant Medsystems. The transaction includes an upfront cash payment of $850 million. Additional payments are contingent on sales performance over the next three years. Minneapolis-based Relievant developed and commercialized the Intracept intraosseous nerve ablation system for chronic pain. The minimally invasive, FDA-cleared, […]
FDA approves next-gen Watchman FLX Pro from Boston Scientific
A string of positive news continues for Boston Scientific , which today announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA 510(k) clearance for its […]
Boston Scientific stock rises on positive Farapulse results — analysts expect FDA approval, rapid adoption
Boston Scientific announced positive 12-month results from the trial of its Farapulse pulsed-field ablation (PFA) system. Shares of BSX rose more than 5% at $53.58 apiece by afternoon trading today. MassDevice’s MedTech 100, — which includes stocks of the world’s largest medical device companies — was up slightly. The pivotal ADVENT trial evaluated the nonthermal […]
Boston Scientific wins expanded FDA clearance for Visual Ice cryoablation system
Boston Scientific announced today that it received expanded FDA 510(k) clearance for its Visual Ice cryoablation system. News of the regulatory nod comes just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib. Clearance grants the device an indication expansion for use in the treatment of pain associated with tumors. […]
The biggest medtech personnel moves so far in 2023
More than halfway through 2023, we’ve seen plenty of movement in the personnel department across medtech. Last July, we broke down the biggest personnel moves in medtech so far in 2022. That was followed up by the full-year report in December. Through more than eight months, the changes atop medtech companies continue to arrive. Some […]