Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation. Read More
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group. Read More
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure. Read More
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago. Read More
New hires and promotions in the med-tech industry, including: Angiodynamics, Beckman Coulter, Cook Medical, Cytosorbents, Danaher, Spectrum Vascular. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Carmat, Elutia, Sequana Medical, Vicarious Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards. Read More
