Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices. Read More
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air. Read More
A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly. Read More
The U.K. National Institute for Health and Care Excellence (NICE) has seen the nation’s spending numbers for diabetes, which is said to account for roughly 10% of healthcare spending in the U.K., and responded in a collaboration with the National Health Service (NHS). Read More
Med-tech firms raising money in public or private financings, including: Apyx Medical, Biosig Technologies, Elucid Bioimaging, Myriad Genetics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artivion, Cryolife, Davion, Koru Medical Systems, Liquid Biosciences, Mainz Biomed, Mediview XR, Neuronetics, Neurx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Holdings, Owlet, Schemaview. Read More
