The U.S. FDA granted Avicenna.AI SAS 510(k) clearance for Cina-VCF, its artificial intelligence-based solution that detects unsuspected vertebral compression fractures (VCFs) in patients undergoing chest or abdomen CT scans. The company hopes that early detection of VCFs will allow patients to be checked for osteoporosis and start treatments early to reduce the risk of their fracture deteriorating. Read More
Omniscient Neurotechnology Ltd. closed a $60 million series C fundraising round to expand its reach in the U.S. market for its Quicktome platform that leverages AI to convert a standard MRI scan into a detailed map of an individual’s brain networks. Read More
The prior authorization practices of Medicare Advantage programs have drawn the ire of industry and physician societies alike recently, prompting the U.S. Centers for Medicare & Medicaid Services to open a request for information in January 2024. Congress seems poised to take matters into its own hands, however, with legislation that would force these plans to work to speed up these prior authorization processes, a bill that has the enthusiastic support of the Medical Device Manufacturers Association. Read More
Avenda Health Inc. said the findings of a new study published in The Journal of Urology demonstrate the ability of artificial intelligence to accurately identify cancer in oncology imaging and diagnostics. Read More
The U.S. Supreme Court unanimously upheld the FDA’s relaxed regulation of the abortion drug mifepristone when it ruled June 13 that the organizations challenging those changes lacked the standing to do so. Read More
The Biosecure Act missed its first chance at a congressional ride June 11 when the U.S. House Rules Committee didn’t include it, as many had expected, on the list of potential riders the House will consider for its version of the National Defense Authorization Act, a must-pass defense spending bill for fiscal 2025. But that doesn’t mean the bill will be stranded by the wayside. Read More
In 2023, med-tech deals culminated in the highest total deal value ever recorded by BioWorld MedTech, totaling $10.63 billion, a 33% increase from the $7.99 billion recorded in 2022. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allmed, Pavmed, Veris, Vyaire, Xeltis. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aktiia, Cario, Providence Medical. Read More
