The U.S. FDA has posted a draft guidance that will overwrite a 2014 draft guidance dealing with MRI compatibility for medical devices, but at least one observer is concerned that the agency posted draft as standards-setting organizations are rewriting their own related device performance standards, a fact that could draw out the time to completion of the draft. Read More
TORONTO – Several U.S. and Canadian patients have recently undergone successful mitral valve surgery featuring a platform designed by Toronto-based Baylis Medical Inc. to provide more precise access to the wall separating the left and right sides of the heart. Robert Harrison, Baylis's director of research and development for cardiology, said in addition to locating the precise puncture point for mitral valve reconstruction, the Versacross transseptal solution has reduced the number of devices exchanged during the procedure to an all-in-one platform. Read More
Medtronic plc, of Dublin, has had a busy week. On Tuesday, it reported that it had received breakthrough device designation from the U.S. FDA for its Valiant TAAA stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). Read More
PARIS – Carmat SA, from Vélizy Villacoublay, France, has just raised $66 million from European specialist investors in the life sciences and medical technologies sector. Read More
The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005. Read More
