The European Commission has granted CE mark approval to Medtronic plc for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). The device is the first Medtronic SCS to sense an individual’s biological cues and make adjustments in real time to control pain all day long. Dublin-based Medtronic plans to launch Inceptiv in Europe in the coming months. Read More
A first-in-human clinical trial conducted by researchers at the Cleveland Clinic demonstrated that deep brain stimulation (DBS) applied to the dentate nucleus region of the cerebellum could help patients recover function in their upper extremities up to three years after a stroke. Results of the study were published in Nature Medicine. Read More
The U.S. Department of Justice (DOJ) has been aggressively pursuing fraud perpetrated on the American public in connection with the COVID-19 pandemic, but the formal end of the U.S. public health emergency might seem to suggest that these efforts would be winding down. Nonetheless, deputy attorney general Lisa Monaco has announced that DOJ will open two new strike force offices under the agency’s COVID fraud operations, making clear that the agency is still intent on chasing down fraudsters across the U.S. Read More
The French National Insurance Fund, known as La Caisse Nationale d’Assurance Maladie, a division reporting to the Ministry of Health and the Ministry of Economics and Finance in France, has released its annual report containing proposals aimed at achieving financial balance in the nation’s health insurance expenditures. The 100-page document will be submitted to the parliament to be voted upon this fall. “These are precise, concrete recommendations drawn up after an in-depth analysis of trends in expenditure and practices,” said Thomas Fatôme, general director of the National Insurance Fund. Read More
SK Bioscience Co. Ltd. and Vaxxas Pty. Ltd. have entered into a joint development agreement that could revolutionize vaccines by developing a vaccine-delivery device combination product using Vaxxas’ high-density microarray patch (HD-MAP) coupled with SK Bioscience’s typhoid vaccine, Skytyphoid. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Boston Scientific, Medtronic, Paragonix, Susmed. Read More
