Selective whistleblower allegations, investigative reports hint at drug GMP issues awaiting US FDA inspection resumption; GSK sotrovimab EUA gets root cause provision; API GMP compliance work acknowledged; Aziyo recalls bone matrix associated with tuberculosis outbreak, and other matters in this latest update.

Transcatheter aortic valve replacement (TAVR) is performed routinely using devices providing protection from stroke as standard of care. However, cerebral embolic protection devices currently available do not capture and remove emboli from all three vessels leading to the brain. The Emblok Embolic Protection System from Innovative Cardiovascular Solutions (ICS) has developed an embolic filter designed to protect all three cerebral vessels during TAVR and remove debris from the entire circulatory system.

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by MedDeviceTracker. This edition covers trial announcements from Feb. 11 through Feb. 24, including announcements from CorMatrix Cardiovascular, Hancock Jaffe Laboratories, Toray Industries, Spectral Medical, GI Dynamics, and Check-Cap.

A roundup of recent medtech mergers & acquisitions, strategic alliances, and financings.