Data from Meril Life Sciences Pvt Ltd.’s Landmark trial showed that its series of Myval transcatheter heart valves were non-inferior compared with Edwards Lifesciences Corp.’s Sapien BEV and Medtronic plc’s Evolut SEV devices, with regards to safety and effectiveness in patients undergoing transcatheter aortic valve implantation.
Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.
May Health SAS closed a $25 million series B financing round to advance its Ovarian Rebalancing therapy for polycystic ovary syndrome (PCOS)-related infertility. The round brings the total funds raised by the Paris-based company to date to $35 million, May Health CEO Anne Morrisey told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro, Oxehealth, Qiagen, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corepath, GTC, IDT, Molecular Health, Neuronetics, Rapid Medical, Sevaro.
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
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