Baxter International Inc. wasted no time in tackling its New Year’s resolution to trim down the business. On Friday morning, the company revealed details around the divestitures it foreshadowed in its third quarter 2022 earnings call with the announcement that it planned a tax-free spin off its Renal Care and Acute Therapies businesses into an independent, publicly traded company within the next 12 to 18 months. Read More
Nuralogix Corp. is taking its selfie-based health monitoring platform to the next level, offering continuous health and vital signs tracking during video calls. The launch of Anura Telehealth is the newest addition its Anura app, which uses video cameras on smartphones and other consumer devices to extract facial blood flow information and provide a personalized snapshot of health and wellness. Read More
Playwright George Bernard Shaw is credited with coining the phrase, “better late than never,” a piece of advice the U.S. FDA seems to have taken to heart when it comes to posting the regulations for first-of-a-kind devices. The agency has posted eight regulations for de novo devices just between Jan. 4 and Jan. 5, 2023, five of those arriving on the latter of those two days in a post-holiday scramble to catch up. Read More
Skynor Medical (Shanghai) Co. Ltd. has raised ¥100 million (US$15 million) in a financing round to step up its efforts in product development and market expansion. More specifically, the Shanghai-based company intends to use the funds to develop its interventional treatment solutions for neuro and peripheral vascular diseases, as well as expand them to markets at home and abroad. Read More
The European Union’s (EU) Artificial Intelligence Act (AI Act) drew a fair amount of criticism when it was first released, but Team-NB, the association of notified bodies (NBs) for the EU, has weighed in with some less than flattering observations. The group’s position paper on the legislation said that the act would not only up-classify some artificial intelligence algorithms to a higher risk class but would also resurrect the backlog of applications because of burdensome new requirements for NBs, thus exacerbating an existing crisis of med tech availability in the EU. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AA Medical, Aquifer Imaging, Assure, Bomimed, Bruker, Cancer Research Horizons, Cardiac Insight, Certified Endoscopy, Diacarta, Fresnius, Helix, Life Spine, Mindray, Neuroprotect Neuromonitoring, Nonagen Bioscience, Prophase, Qiagen, Stella, Suono Bio, Turbine. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Prapela. Read More
