Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone. Read More
Intersect ENT Inc., of Menlo Park, Calif., picked up Fiagon AG Medical Technologies less than two years ago in a bid to expand its footprint in the ear/nose/throat (ENT) business, but that acquisition is about to be undone. The U.S. Federal Trade Commission (FTC) said Intersect will have to jettison Fiagon because of Dublin-based Medtronic plc’s acquisition of Intersect, thus unwinding a transaction that was valued at €60 million (US$62.4 million) in September 2020. Read More
Germitec SA has raised €11 million (US$11.6 million) to finance commercial scale-up, as it prepares to submit for FDA 510k approval of its ultrasound probe disinfection system. Read More
Following the termination of a planned merger with SPAC Medtech Acquisition Corp., Tel Aviv-based Memic Innovative Surgery Ltd. is looking to slowly roll out its Hominis surgical platform. Nasdaq-listed SPAC Medtech and Memic called off the agreement due to “market volatility and world events.” Read More
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance. Read More
Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter. Read More
In an effort to increase global access to COVID-19 technologies, the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool finalized a licensing agreement May 12 with the U.S. NIH for research tools, early stage vaccines and diagnostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biofourmis, Bio-Techne, Eurekare, Eureking, Exagen, Lucira Health, Luminex, Makromed, Medx Health, Neuronetics, Nonagen Bioscience. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Medmira, Remedee Labs, Wysa. Read More
