The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.
The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.
Bioventus LLC continues to strengthen its portfolio through acquisitions and investments with a move to exercise its option to purchase Cartiheal Ltd. for $315 million up front and a potential payment of $135 million contingent on achievement of $100 million in trailing 12-month sales. The Cartiheal transaction follows the acquisition of Bioness Inc. and Misonix Inc. last year. Cartiheal developed the Agili-C implant, which received FDA breakthrough device designation in 2020 and premarket approval last week.
Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ariste Medical, Baxter, Bearpac Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alira Health, Canute Medical, Cutera, Electrocore, Endoclot Plus, IBA, Nanovibronix, Olympus, Probo Medical, Sourcia, Unidoc.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
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