The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
Twelve-month results from Fractyl Health Inc.’s real-world registry show sustained, significant weight loss following treatment with its Revita procedure, which uses ablation to resurface the mucosal lining of the duodenum.
Croívalve Ltd. raised $16 million in a series B financing round that will be used to fund a clinical trial in the U.S. looking at the safety and performance of its Duo system to treat patients with severe or greater symptomatic tricuspid regurgitation.
Seoul, South Korea-based Adel Inc. raised ₩17 billion (US$12.39 million) in bridge financing to advance its pipeline of Alzheimer’s disease therapies, including its tau antibody-based ADEL-Y01 candidate, currently in a U.S.-based phase I study.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Lensar, Orthogrid Systems, Paragonix, Unilabs, C2N Diagnostics, Vicarious Surgical, Zimmer Biomet.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aventamed, Centerline Biomedical, Huxley Medical, Medtronic.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Guardant Health, Icecure Medical, Materna Medical.
The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
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