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.
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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aethlon Medical, Fractyl Health, Pacira Biosciences, Ziwig.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Francis Medical, Roche, Truvian.
Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.
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