The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth. Read More
A brighter future awaits radiotherapy if Flash and LIGHT live up to their promise. Announcements made last week by Varian Medical Systems and Advanced Oncotherapy plc indicate results should be seen soon. Varian reported that the first human clinical trial of Flash, Fast-01, completed its treatment phase last week at the Cincinnati Children’s/University of Cincinnati Health Proton Therapy Center. Advanced Oncotherapy plc presented results from a modeling study of Linac for Image Guided Hadron Therapy (LIGHT) technology at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting demonstrating that LIGHT enables both the high, super-quick dose delivery of Flash and good conformality of dose delivery to tumor tissue. Read More
The U.S. Department of Justice (DoJ) reported a new set of policies dealing with federal prosecutions of corporate misconduct that includes a far-reaching policy on disclosure. Deputy attorney general Lisa Monaco announced Oct. 28 that companies will have to disclose all non-privileged information in connection with alleged misconduct rather than just information regarding those who were “substantially involved.” Read More
The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead. Read More
PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes. Read More
Asahi Intecc Co. Ltd. is tapping Hexagon Manufacturing Intelligence Inc.’s non-linear structural analysis software, Marc, to develop delivery devices that carry markers to the vicinity of cancers in preparation for endoscopic surgery. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alaycare, Delta Health, Dariohealth, Inagene, Granville Biomedical. Read More
