Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for its pulsed field ablation (PFA) system. The approval allows Pulse to proceed with the initiation of the NANOCLAMP AF study. NANOCLAMP AF evaluates the company's nanosecond PFA (nsPFA) Cardiac Surgery System for treating AFib. According … [Read more...] about Pulse Biosciences wins FDA IDE to conduct study of PFA tech for AFib
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Kardium gets FDA green light for Globe pulsed field ablation system
Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software. With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like … [Read more...] about Kardium gets FDA green light for Globe pulsed field ablation system
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company's first — allows it to begin a pivotal clinical trial of the technology. Central airway … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Boston Scientific has a serious recall for carotid WallStent monorail endoprosthesis
The FDA issued a notice outlining a serious recall of the Boston Scientific carotid WallStent monorail endoprosthesis. According to the FDA, the device may cause serious injury or death with continued use, making it the most serious type of recall. Boston Scientific instructed users to immediately stop using affected devices and remove them from … [Read more...] about Boston Scientific has a serious recall for carotid WallStent monorail endoprosthesis
Stereotaxis gets FDA green light for robotic electrophysiology mapping catheter
Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its Magic Sweep navigation catheter. The company touts Magic Sweep as the world's first robotically navigated high-density electrophysiology (EP) mapping catheter. High-density mapping enhances cardiac ablation procedures through more efficient, detailed and precise … [Read more...] about Stereotaxis gets FDA green light for robotic electrophysiology mapping catheter
Edwards recalls certain arterial cannula devices
The FDA today issued a notice warning of a recall of arterial perfusion cannula devices made by Edwards Lifesciences (NYSE: EW). Edwards offers its arterial perfusion cannulae for adult patients undergoing cardiopulmonary bypass. They provide arterial perfusion of oxygenated blood in the extracorporeal circuit for up to six hours. The company … [Read more...] about Edwards recalls certain arterial cannula devices
Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA
Johnson & Johnson MedTech today announced FDA approval for an update to its Varipulse platform's irrigation flow rate. The company said the update to its pulsed field ablation (PFA) platform reflects its commitment to the evolution of PFA innovation. Its update came on the back of real-world clinical practice. Johnson & Johnson MedTech's … [Read more...] about Johnson & Johnson MedTech gets updated FDA nod for Varipulse PFA
Boston Scientific wins expanded FDA nod for Farapulse PFA
Boston Scientific (NYSE: BSX) announced today that the FDA approved an expansion to the label of its Farapulse pulsed field ablation (PFA) system. Farapulse, one of the leading PFA systems for treating AFib, received a much-anticipated FDA approval last year. The system treats AFib by delivering pulsed field energy through a catheter to ablate … [Read more...] about Boston Scientific wins expanded FDA nod for Farapulse PFA
FDA adds Gradient denervation tech to advisory program
Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle 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 medical devices. The company expects its acceptance into … [Read more...] about FDA adds Gradient denervation tech to advisory program
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) … [Read more...] about Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
