The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities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.
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
The U.S. FDA has granted a breakthrough device designation to Ancora Heart Inc. for its Accucinch ventricular restoration system. The minimally invasive treatment is intended to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these advanced cell models.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Beigene, G1, Lantern, Novavax, Revolo, Sinovac, Summit.
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities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.
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