Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday. Read More
A U.K. national health service (NHS) hospital has begun offering Allurion Technologies Inc.’s swallowable gastric balloon to patients struggling to lose weight for surgery. The move is a boon for the company amid rising competition in the weight loss market from GLP-1 agonists. Read More
Ovarian cancer diagnostics company, Cleo Diagnostics Ltd. has developed a blood-based diagnostic test for ovarian cancer based on the CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease. Read More
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023. Read More
IMU Biosciences Ltd. has raised £11.5 million (US$14.7 million) in a series A round to further develop and commercialize profiling technology that can identify from a blood sample which of more than 2,000 cell types are present in an individual’s immune system. Read More
The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aifred, Amerisourcebergen, BD, Bruker, Cencora, Centogene, Chemspeed, Debiopharm, Genialis, Intelligent Bio, Sigrid Therapeutics, SS Innovations. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Able Medical, Absolutoins, Croívalve, Enhatch, Intuitive Surgical. Read More
