Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endonovo Therapeutics, Foundation Medicine, Infobionic, Medtronic.

With an eye on making the U.K. more attractive for clinical trial research, the Medicines and Healthcare products Regulatory Agency took a step Oct. 12 to overhaul its clinical trials regulations by reducing the approval time for the lowest-risk studies.

Responding to the burgeoning field of digital health, the U.S. FDA reported the creation of a new Digital Health Advisory Committee that it expects to be up and running in 2024.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Neoss, Orthofix Medical, Sentiar.

Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy devices, but a new problem has emerged that promises to add yet more drag to the process. Amie Smirthwaite, senior vice president for innovation at RQM+, said EU member states’ competent authorities seem bent on pressing notified bodies (NBs) to treat guidance by the Medical Device Coordination Group (MDCG) as regulation, with the net result that “you almost need guidance for the guidance” in order to successfully navigate the EU market.