Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
Boston Scientific
Boston Scientific stock is up as Farapulse drives Q1 beat, raised guidance
Boston Scientific shares got a boost this morning on first-quarter results that came in ahead of the consensus forecast. Shares of Boston Scientific ticked up nearly 7% to $73.66 apiece in early-morning trading today. They got as high as $74.39 during the day, marking a 52-week best for the company. MassDevice’s MedTech 100 Index — […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system to block or occlude blood flow to specific blood […]
Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific announced today that it began a new study of its Faraview software module for the Farawave pulsed field ablation (PFA) catheter. The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave Nav catheter expand the capabilities of the Boston Scientific […]
FTC wants more info on Boston Scientific, Axonics deal with closing timeline pushed back
Boston Scientific said today that the FTC requested additional information regarding its planned $3.7 billion acquisition of Axonics (Nasdaq:AXNX). In an SEC filing, Boston Scientific said both it and Axonics received requests from the FTC (U.S. Federal Trade Commission). The agency seeks to gather more information in connection with its review of the merger. Reports […]
Boston Scientific, Scivita partner on endoscopic devices
Boston Scientific and Scivita Medical announced that they entered into an expanded strategic cooperation arrangement focused on endoscopic technology. Scivita, a China-based medtech company, provides minimally invasive diagnosis and treatment solutions. It focuses on R&D and commercialization for medical endoscopes and related products. The company aims to globalize its operations through strategic cooperations with companies […]
Axonics stockholders approve Boston Scientific acquisition
Axonics (Nasdaq:AXNX) announced that its stockholders voted to adopt its $3.7 billion merger agreement with Boston Scientific . Boston Scientific announced its intent to buy Axonics on Jan. 8. Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. […]
Boston Scientific has positive Agent DCB study results
Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]
FTC reportedly may scrutinize Boston Scientific’s Axonics deal
Bloomberg reports that the U.S. Federal Trade Commission (FTC) may look into the $3.7 billion acquisition of Axonics (Nasdaq:AXNX) by Boston Scientific . A new Axonics regulatory filing with the SEC discloses that the companies refiled their Hart Scott Rodino (HSR) Act notification to the FTC on March 4 — a move that companies sometimes […]
FDA approves Boston Scientific’s Agent drug-coated balloon
Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]