Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Appili, Cordis, Gradient Denervation, ITM Isotop, Radiopharm.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Trax Surgical.
Regeneron Pharmaceuticals Inc. was the successful bidder for 23andme Holding Co.’s personal genome service, total health and research services business lines, including its biobank and associated assets, in the bankruptcy auction to sell 23andme's assets.
Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
Step aside, Marco Polo: Kakao Healthcare Corp. plans to bring PASTA to Japan. PASTA is Kakao's AI-based continuous glucose monitoring (CGM) management mobile application, which will be available in Japan through a new subsidiary as the health care company works to expand its global presence.
Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based
diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
In what represents just the company’s third PCT filing, Houston-based Starling Medical Inc.’s co-founders, Hannah McKenney and William Hendricks, seek to gain further protection for their at-home urine diagnostic patient-monitoring platform that eliminates the traditional use of catching containers and dipsticks.