The U.S. FDA’s intended use rule has been in flux for the past half-decade, with yet another draft rule making the rounds for comment. Despite any concerns that speech regarding off-label use might again be seen as a primary driver of prosecution, Sara Bloom, senior litigation counsel at the U.S. Department of Justice’s District of Massachusetts office, said distribution of the product in question is frequently the key feature where federal prosecutors are concerned. Bloom said communication of off-label use often serves primarily as a confirmatory element of the manufacturer’s intent rather than as the decisive part of the prosecution’s case.
The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. Patient enrollment is expected to begin in early 2021.
Keeping you up to date on recent developments in orthopedics, including: HSS bone study sheds light on complications after spinal surgery; Simplify Medical reports first implant of its cervical artificial disc in the U.S. following FDA 1-Level approval; Scientists say xenon improves properties of maxillofacial and orthopedic implants.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott Laboratories, Apollo Endosurgery, Aroa Biosurgery, Avenda Health, Biotronik, Miach Orthopaedics, Okami Medical, Spark Biomedical, Transenterix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aroa Biosurgery, Hancock Jaffe Laboratories, Smith+Nephew, Twistrand Biosciences, Veracyte.
PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals.
RSS
