B-Temia Inc.’s Keeogo mobility device is on the move in the U.S. now that it has received 510(k) clearance from the U.S. FDA. Unlike currently available exoskeletons that move for patients, the Keeogo (keep on going) Dermoskeleton system amplifies signals from patients who can initiate movement but need additional assistance.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, B-Temia, Fitbit, Micron Medical.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Cycle, Essa, Gan & Lee, Gannex, Kiadis, Mateon, Novartis, Pharmacyte, Regeneron, Reven, Sanofi, SK, Seneca, Supernus, Vaxart, Vertex, Ziopharm.
LONDON – With just four months to go until Brexit is activated, the start of September finally saw the med-tech industry get official guidance on the licensing regime for medical devices in the U.K. once the Medicines and Healthcare Products Agency (MHRA) becomes the standalone regulator Jan. 1, 2021.
PARIS – For the past three years, French health care establishments, hospitals, radiotherapy centers and medical biology laboratories have had to report any security incidents affecting their IT systems. The French national agency for digital health care (ANS) has just released its latest annual report.
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