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.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anthos, Arcutis, Can-Fite, Iterum, Lipocine, Perrigo, Pfizer, SCG.
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception.
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