Insulet Corp. has taken the lead in the race to bring insulin delivery systems to individuals with type 2 diabetes with U.S. FDA clearance of its Omnipod Go device. The delivery system is adapted for use by adults who use once-a-day basal insulin. The company plans to roll out Go in 2024. Read More
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being. Read More
The €15 million (US$16.45 million) loan Smart Reporting GmbH recently received from the European Investment Bank (EIB) will take the company a “long way” as it looks to expand the use of its artificial intelligence (AI)-based medical documentation technology which “helps clinicians improve their workflow and patients to get better care,” co-CEO Peter Vanovertveld, told BioWorld. Read More
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29. Read More
Meio Medical Inc.’s Titian, a surgical robot for navigation in cardiac electrophysiology, has been included in a Green Pathway for approval of medical devices in China, meaning it could get to market faster. Inclusion in the Green Pathway gives the medical device priority for reviewing and shortens the average registration time. Currently, Meio Medical is running a trial of Titian in multiple hospitals in China. Read More
New hires and promotions in the med-tech industry, including: Butterfly Network, C2N Diagnostics, Elucid, KCAS, Veris Health, Science 37, Thomas Scientific. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Moleculight, Myocene. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autism Analytica, Avenda, Click, Concertai, Cryoport, Limber Prosthetics, Nevro, Pathai, Quadrant Biosciences, Siemens, Siemens Healthineers, Trinity Biotech. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carl Zeiss Meditec, Insulet, Proprio. Read More
