At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” aims to support the iterative improvement central to many algorithms while minimizing potential issues with safety and efficacy.
The congressional finger-pointing at pharmacy benefit managers (PBMs) continues. The latest singling out is in a bipartisan letter from four House members calling on the U.S. Department of Justice to investigate and hold PBMs accountable for the role they played in the nationwide opioid crisis.
Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
Neo Medical SA received certification under the EU Medical Device Regulation for its entire portfolio of spine surgical technologies. The approval means that the company can continue selling its products, which helps with the surgical treatment of back pain, across markets in Europe as they are in compliance with the high-quality control standards required for medical devices.
Alveogene Ltd. has announced its novel inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency, AVG-002, has been awarded orphan drug designation by the FDA.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. won local approval of the first China-made trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC), sacituzumab tirumotecan, as a third-line therapy for advanced breast cancer.
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