Australian respiratory imaging technology company 4dmedical Ltd. raised AU$150 million (US$105 million) in an institutional placement to accelerate U.S. adoption of its CT:VQ lung imaging software to bolster the company’s lead in software-based lung imaging.
Six-month results from the REMAIN-1 trial showed that Fractyl Health Inc.’s Revita procedure cut post-GLP-1 weight regain by about 70% compared with a sham procedure in patients who discontinued incretin-based drugs such as semaglutide and tirzepatide after achieving substantial weight loss.
En Carta Diagnostics SA's EC Pocket Lyme received FDA breakthrough device designation for its rapid, molecular diagnostic test for the early detection of Borrelia bacteria, which causes Lyme disease. The designation marks a pivotal step for the French startup as it will enable closer interaction with the agency, accelerating its route to market, and getting it to patients sooner.
A Jan. 28 report on Medicare spending on lab tests indicated that spending on many types of tests flattened between 2022 and 2024, but spending on genetic tests rose 20% between 2023 and 2024 to $3.6 billion. While the report does not specifically call out fraud as a driver of spending, the U.S. Department of Justice posted a Jan. 26 press release identifying a case of Medicare gene testing fraud that amounted to $52 million, just one of several recent examples of this kind of fraud.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcrev, En, Laborie, Moleculight, Organon, Revbio, Sensible Medical, Symmetry Laser.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CSD Labs, Nextbiomedical, Spectrum Dynamics.