Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily.
The second day of the U.S. FDA’s orthopedic devices advisory panel included a proposal to down-classify semi-constrained toe joint prostheses as class II devices, but the panel was adamant that such devices be slotted in class III, with one panelist referring to the literature for these devices as “garbage.”
Minnetronix Medical Inc. has won the U.S. FDA’s nod for its Mindseye Expandable Port for neurosurgical procedures. The company touts the device as the first minimally invasive, retractable deep brain access system for use in the treatment of stroke, cancer and other conditions.
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.
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