Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neuromatrix, Snyders Heart Valve, St. Jude Medical, Thermo Fisher Scientific.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alydia Health, Ka Imaging, Procisedx, Thermo Fisher Scientific.
The agenda for the U.S. FDA’s Sept. 8-9 advisory hearing includes a proposed down-classification of bone growth stimulator (BGS) devices to class II, but while the proposal met some resistance from an industry group, the panel sided with the FDA and declared BGS units ready for prime time as 510(k) devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inspiremd, Roche, Theranica.
LONDON – Gyroscope Therapeutics Ltd. is poised to move the field of ocular gene therapy on from the treatment of inherited rare diseases to address more common eye conditions, after receiving FDA 510(k) clearance for its Orbit SDS subretinal delivery device.
HONG KONG – Tokyo-based Cureapp Inc. has received the Ministry of Health, Labour and Welfare (MHLW)’s green light to manufacture and sell Cureapp SC [Smoking Cessation] Nicotine Addiction Treatment App and CO Checker, its therapeutics app to aid patients who are quitting smoking.
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