New hires and promotions in the med-tech industry, including: Butterfly Network, C2N Diagnostics, Elucid, KCAS, Veris Health, Science 37, Thomas Scientific.
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.
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.
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.
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.
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.
Avanos Medical Inc. recalled 1,000 units of two of its Ballard Access suction systems for use in clearing artificial airways in neonatal and pediatric patients because of multiple complaints of cracked device manifolds. The recall affects 1,000 units distributed in the U.S. between October 2022 and January 2023, but this is the second recall of Avanos products in less than a year.
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