Boston Scientific (NYSE: BSX) announced today that it will purchase Ajax Health's Cortex and its FDA-cleared OptiMap system to guide physicians performing ablation procedures to treat AFib Financial terms of the deal were not disclosed. Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing … [Read more...] about Boston Scientific to acquire Cortex and its cardiac mapping tech
Catheters
Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Merit Medical Systems (Nasdaq:MMSI) announced today that it completed its acquisition of Cook Medical’s lead management portfolio. South Jordan, Utah-based Merit announced its agreement to buy the portfolio for $210 million in September. Merit funded the acquisition through a combination of cash on hand and borrowings under a long-term credit … [Read more...] about Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Johnson & Johnson completes pilot enrollment in Omnypulse trial
Johnson & Johnson MedTech today announced the completed enrollment of the pilot phase of a clinical trial for its Omnypulse platform. The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase … [Read more...] about Johnson & Johnson completes pilot enrollment in Omnypulse trial
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer … [Read more...] about Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Jupiter Endovascular reports first patient treated in U.S. study of Vertex pulmonary embolectomy system
Jupiter Endovascular today announced the first U.S. patient treated in its SPIRARE II U.S. pivotal study for the Vertex system. The first U.S. patient treated follows last month's announcement of the first Vertex use in the SPIRARE I study in Poland. SPIRARE II evaluates the Vertex pulmonary embolectomy system in the treatment of acute pulmonary … [Read more...] about Jupiter Endovascular reports first patient treated in U.S. study of Vertex pulmonary embolectomy system
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical … [Read more...] about FDA approves IDE for Medtronic Prevail drug-coated balloon
Nerve ablation tech developer Autonomix to effect a reverse stock split
Autonomix (Nasdaq:AMIX) announced today that it filed to effect a 1-for-20 reverse stock split of its common stock. The Woodlands, Texas-based Autonomix plans for the split to take effect at 11:59 p.m. ET on Oct. 24, 2024. It plans for its common stock to open trading on the Nasdaq market on Oct. 25, 2024, on a post-split basis, under the … [Read more...] about Nerve ablation tech developer Autonomix to effect a reverse stock split
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused by cancer. The novel, proprietary therapy platform is indicated for treating tracheobronchial strictures produced by … [Read more...] about Peytant wins FDA de novo nod for covered stent system
Gradient adds former Edwards exec to board as FDA approves trial expansion
Gradient Denervation Technologies announced today that it appointed medical device entrepreneur and executive Stanton Rowe to its board. Paris-based Gradient also said the FDA approved an expansion of its early feasibility study of its hypertension treatment. The company develops a minimally invasive, ultrasound-based catheter device for … [Read more...] about Gradient adds former Edwards exec to board as FDA approves trial expansion
Okami Medical closes $32.5M financing to support catheter tech for peripheral vascular occlusion
Okami Medical announced today that it closed a $32.5 million financing round to support its catheter-based technologies. Aliso Viejo, California-based Okami develops multiple technologies for peripheral vascular occlusion. To date, it developed the LOBO (low-profile braided occluder) vascular occlusion system and the Sendero … [Read more...] about Okami Medical closes $32.5M financing to support catheter tech for peripheral vascular occlusion
