Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure. Read More
Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from existing shareholders. Read More
The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders. Read More
The U.K. National Institute for Health and Care Excellence announced an increase in the cost effectiveness thresholds for its health technology assessment program, but this new threshold falls far short of where the figure should be when adjusting for inflation. Read More
SS Innovations International Inc. is experiencing rapid growth and rising demand for its SSi Mantra 3 surgical robotic system. Its revenues are increasing, and so are installations and procedures driven by the design features and affordability of the SSi Mantra, said Sudhir Srivastava, chairman of the board and CEO of SS Innovations. “The system that we have created is, in my personal opinion, better than anything that exists out there because of its various differentiating features and cost effectiveness,” he told BioWorld. Read More
So much for stability at the U.S. FDA. Three weeks after accepting the position as director of the FDA’s CDER, Richard Pazdur has informed the agency of his intention to retire at the end of the year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aethlon Medical, Fractyl Health, Pacira Biosciences, Ziwig. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Tau, Bionex Solutions, Companion Spine, CQ Medical, Hemasense, Mainz Biomed, O2matic, Openwater, Paradigm Spine, Seastar Medical, Xtant Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Francis Medical, Roche, Truvian. Read More
