Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beyond Air, Imperative Care, Myocene, Norlase, Panopticai, Stereotaxis.
Neko Health AB raised $260 million in its series B funding round to expand the reach of its artificial intelligence (AI)-driven full body scanning technology to meet growing demand. The fund raise comes amid an increasing shift in behaviors towards more preventative measures in health care in a bid to remove the risk of developing chronic diseases.
Murray Hill, N.J.-based C.R. Bard Inc. agreed to pay roughly $17 million to settle allegations that it violated the Anti-Kickback Statute in connection with the use of a self-referral form for sales of the company’s intermittent catheter.
Researchers from Children’s Hospital Los Angeles and the University of Southern California filed for protection of a pacemaker with a unique shape and configuration which is low profile.
A pair of investor calls on Jan. 22 added clarity to the rapidly evolving cardiac ablation market with Abbott Laboratories and Johnson & Johnson providing updates on their pulsed field ablation programs. Both outlined challenges in the U.S. market that continue to place them at a disadvantage compared to current market leaders Boston Scientific Corp. and Medtronic plc, though bright spots also shone through.
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
Med-tech firms raising money in public or private financings, including: Grey Matter Neurosciences, Median Technologies, Neko Health, Semler Scientific, Xaga Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Spine and Pain Management, Caranx Medical, Eneura, Grey Matter Neurosciences, Milestone Scientific, Recon Supply, Surgery Hero, Sword Health.