The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
Venus Medtech (Hangzhou) Inc. received the green light in China for its transcatheter pulmonic valve replacement (TPVR) system Venusp-Valve. It is a self-expanding TPVR product for the treatment of severe pulmonary regurgitation (≥3+) in patients after a congenital heart defects procedure with native right ventricular outflow tract.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Centinel Spine, Onkos Surgical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Avrobio, Immedica, Neoimmunetech, Orthox, Provepharm, Rznomics, SK.
Infervision Medical Technology Co. Ltd. received approval from China’s NMPA for its radiological computer-assisted triage and notification software device Inferread CT Stroke. This is the first class III approval that the firm obtained in the cerebro-cardiovascular field. Class III approvals are for high-risk medical devices.
The U.S. FDA’s two-day meeting of the patient engagement advisory committee (PEAC) covered a range of issues surrounding augmented reality (AR) and virtual reality (VR) products, but patient information and education was one of the key considerations. Naiem Nassiri of Yale Medicine cautioned, however, that a 15-minute briefing between doctor and patient during a face-to-face encounter would likely create more confusion than clarity, a conclusion that would suggest that other patient education methods will likely be needed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpheus, Bone Solutions, Venus Medtech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Bellus, Byondis, Citius, Cyxone, Dyne, Fresenius, Greenwich, Novartis, Y-mabs.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Ancora Heart, Aurora Spine, Eko.
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