Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x Genomics, Boston Scientific, Cleerly, Bunkerhill Health, Deepqure, Discure Technologies, Levee Medical, Lunit, Microlight3D, Optellum, Parse Biosciences, Spinal Stabilization Technologies, Volpara.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Shandon Diagnostics.
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million up front and $200 million upon achievement of a regulatory milestone.
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
RSS
