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Boston Scientific Corporation develops and markets less invasive medical devices and therapies used by healthcare professionals and institutions globally. News about BSX centers on operating results, business highlights, capital-structure updates and product developments across cardiovascular, respiratory, digestive, oncological, neurological and urological care.
Recurring company updates include clinical evidence and regulatory milestones for platforms such as FARAPULSE pulsed field ablation, WATCHMAN left atrial appendage closure, EKOS endovascular therapy and the Asurys Fluid Management System. Coverage also reflects conference presentations, FDA clearances, trial results and management discussions of quarterly performance across the company’s medical-technology portfolio.
BTG Specialty Pharmaceuticals, a division of Boston Scientific (NYSE:BSX), announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for Voraxaze® (glucarpidase). This application aims to authorize Voraxaze® for treating adults and children at risk of methotrexate toxicity due to delayed elimination. The MAA is underpinned by clinical data and real-world experience, having previously treated nearly 3,000 patients in the US since FDA approval in 2012. A decision from the EMA could lead to marketing authorization across the EU and additional countries.
Boston Scientific reported Q2 2020 sales of $2.003 billion, marking a decline of 23.9% year-over-year. The company faced a GAAP loss of $147 million or $(0.11) per share, a drop from earnings of $154 million or $0.11 per share in the prior year. Adjusted EPS was $0.08, down from $0.39. Sales declined across all segments due to the COVID-19 pandemic, with declines of 29.6% in MedSurg and 33.2% in Rhythm and Neuro. The company received multiple FDA approvals, boosting its product pipeline.
Boston Scientific received FDA approval for the WATCHMAN FLX Left Atrial Appendage Closure Device, aimed at reducing stroke risk in patients with non-valvular atrial fibrillation. This next-generation device enhances maneuverability and offers a fully recapturable and repositionable design. Positive results from the PINNACLE FLX study showed a 0.5% major complication rate and high effectiveness with 100% effective closure at 12 months. The device is available in broader sizes, increasing its market potential. A limited launch in the U.S. is set to commence.
Boston Scientific Corporation (NYSE: BSX) will host a conference call on July 29, 2020, at 8:00 a.m. EDT, to discuss its second-quarter financial results for the period ending June 30, 2020. The call, led by CEO Mike Mahoney and CFO Dan Brennan, will include insights on business highlights. The company plans to release its financial results prior to the call. Investors can access the call and its replay on the Boston Scientific Investor Relations website.
Boston Scientific (NYSE: BSX) has obtained FDA 510(k) clearance for its LUX-Dx™ Insertable Cardiac Monitor (ICM) System, designed to detect arrhythmias related to conditions like atrial fibrillation and cryptogenic stroke. This new device features a dual-stage algorithm for verifying arrhythmias and allows remote programming via the LATITUDE Clarity™ Data Management System. The LUX-Dx ICM can identify key cardiac events and reduces false positives, enhancing clinical decision-making. A limited market release will start immediately, with full launch later this year.