The U.S. FDA has given the green light to Aeye Health Inc. for its autonomous diagnostic screening system for diabetic retinopathy. The Aeye Diagnostic Screening (Aeye-DS) uses artificial intelligence (AI) to diagnose the eye condition from retinal images captured by a fundus, or retinal, camera.
Cybersecurity has become one of the core concerns for med tech in this part of the 21st Century, and a collaboration between the FDA and the Mitre Corp., has yielded a new playbook that calls for a regional response to issues such as ransomware. However, this new document calls on medical device manufacturers to take part in cybersecurity exercises along with health care delivery organizations, an exercise that some manufacturers might not be prepared to undertake.
The U.S. Department of Health and Human Services (HHS) has issued a bulletin in connection with the Venus ransomware, the latest in a running series of such malware to hit computer systems across the globe.
Acotec Scientific Holdings Ltd. obtained marketing approval from the U.S. FDA for its peripheral support catheter Vericor, designed to enhance access to peripheral vessels.
Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests.
The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.
Acting on its new promise to restore “rigorous enforcement” of the U.S. ban on unfair methods of competition, the FTC filed an amicus brief Nov. 10 supporting Avadel CNS Pharmaceuticals LLC’s motion to delist a Jazz Pharmaceuticals Inc. patent from the FDA’s Orange Book.
Viatris Inc.’s chief information officer, Ramkumar Rayapureddy, is facing an SEC insider trading complaint, along with criminal charges brought by the fraud division of the U.S. Department of Justice. Another man, Brian Wong, was charged with illegal trading ahead of Merck & Co. Inc.’s acquisition of Pandion Therapeutics Inc.
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year.
The U.S. FDA hit a Phoenix-based Abraxis Biosciences LLC facility with a warning letter citing out-of-control aseptic manufacturing processes for Abraxane (paclitaxel), a key chemotherapy drug. The letter, posted Nov. 8, noted that multiple media fill failures occurred last year during simulated aseptic processing operations on the Abraxane filling line.
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