Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system. The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to […]
Farapulse
Boston Scientific has more positive Farapulse pulsed-field ablation data
Researchers shared positive data from a large, real-world registry of patients treated with the Boston Scientific Farapulse system. Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. […]
Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million. Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support preclinical-to-clinical development activities. That includes first-in-human studies slated to begin in early […]
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 […]
Report: Medtech dollars, deals hit new highs in first half of 2021
Fueled at least in part by exceptionally strong IPO and M&A markets, hedge funds, venture capitalists, private equity firms and corporate investors are committing more time and money into privately held medical devices companies, according to a new “Healthcare Investments and Exits” report issued by Silicon Valley Bank. The report examining the first half of […]
Boston Scientific pulls trigger on Farapulse acquisition
Boston Scientific (NYSE:BSX) announced today that it exercised its option to acquire the remaining shares of Farapulse. Marlborough, Mass.-based Boston Scientific first announced its intent to acquire Farapulse in September 2020, when it signed an investment agreement with an option to acquire the pulsed-field ablation (PFA) technology developer. Boston Scientific has been an investor in […]
DTW Podcast: Can Boston Scientific close the gap?
Following the killing of George Floyd in June, medtech companies stood strongly against inequality and racism and promised to push for change. Boston Scientific’s executive committee, including CEO Michael Mahoney, issued one of the earliest statements to condemn “injustice and discrimination and to reaffirm our commitment to live by our values and cultivate a workplace […]
The top 5 MassDevice stories of the week — September 25, 2020
The past week in medtech saw Boston Scientific (NYSE:BSX) make an interesting move in the Afib space — and much more. Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top […]
Boston Scientific may buy Afib treatment startup Farapulse
Boston Scientific (NYSE:BSX) announced today that it signed an investment agreement with an option to acquire Farapulse. Menlo Park, Calif.-based Farapulse has developed a pulsed-field ablation (PFA) system for treating atrial fibrillation (Afib) and other cardiac arrhythmias. The PFA system is designed with a sheath, a generator and catheters to ablate heart tissue through a therapeutic […]
