Johnson & Johnson (NYSE: JNJ) is launching the latest version of its intravascular lithotripsy catheter for cracking calcium within the coronary arteries, which the company said it designed to cut treatment times in half. The Shockwave C2 Aero Fly catheter delivers ultrasonic energy at double the speed of its previous version and with less … [Read more...] about J&J launches faster Shockwave coronary catheter in the US
Pre-Market Approval (PMA)
Haemonetics wins FDA approval of PerQseal Elite vascular closure system
Haemonetics (NYSE: HAE) has received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures, following the company's $116.4 million acquisition of Vivasure Medical in January 2026. The FDA approval, announced yesterday, expands Boston-based Haemonetics' U.S. portfolio of large-bore closure devices for … [Read more...] about Haemonetics wins FDA approval of PerQseal Elite vascular closure system
FDA approves Gore bridging stent graft in complex aortic aneurysms
W. L. Gore & Associates received expanded FDA approval, broadening the use of its balloon-expandable stent graft, opening it up for the treatment of complex aortic aneurysms. The Viabahn VBX endoprosthesis was greenlit for use in both fenestrated and branched endovascular aortic repairs, known as FEVAR and BEVAR, where an aneurysm develops … [Read more...] about FDA approves Gore bridging stent graft in complex aortic aneurysms
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
Artivion earns FDA nod for aortic arch prosthesis device
Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis device. The approval covers acute Debakey Type 1 aortic dissections with either clinical or radiographic malperfusion. Atlanta-based Artivion estimates that this population comprises approximately 60% of all Debakey Type 1 aortic … [Read more...] about Artivion earns FDA nod for aortic arch prosthesis device
Stereotaxis MAGiC cardiac ablation catheter wins FDA approval
Stereotaxis (NYSE:STXS) has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be eligible for cardiac ablation to treat complex and critical heart rhythm disorders. MAGiC is short for "magnetic interventional ablation catheter," an abbreviation … [Read more...] about Stereotaxis MAGiC cardiac ablation catheter wins FDA approval
Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Edwards Lifesciences [WtwhTicker symbol="EW"](NYSE: EW)[/WtwhTicker] has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR). The company said it's the first approval for a transcatheter MR therapy utilizing a transseptal approach. The approval came earlier than Edwards expected. The … [Read more...] about Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
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
Instylla earns FDA premarket nod for hydrogel embolic system
Instylla announced today that it received FDA premarket approval (PMA) for its flagship Embrace hydrogel embolic system (HES). The Bedford, Massachusetts-based company received approval for Embrace for the embolization of hypervascular tumors (HVTs) in peripheral arteries ≤ 5mm. HVTs commonly occur in the liver, kidney, bone and other organs, … [Read more...] about Instylla earns FDA premarket nod for hydrogel embolic system
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
