The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for many such applications. However, the draft states that clinical testing may be required when a manufacturer intends to claim that their guides could reduce surgical times.
Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups.
South African Rugby and the U.S. National Football League (NFL) are actively studying ways to more quickly and reliably diagnose concussions and find more effective treatment for their sequelae. Researchers at the University of Birmingham and Marker Diagnostics Ltd. have identified a biomarker that signals a concussion has occurred, while a team at Electrocore Inc. is working with the NFL to address post-concussion headaches.
Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.
Five months after raising $45 million, Lunaphore Technologies SA reported its consent to be acquired by Bio-Techne Corp., a reagents and instruments manufacturer for the diagnostic market. This acquisition by the Nasdaq-listed bio-tech giant, “will enable us to begin a worldwide commercial rollout of our products and automated spatial biology technology,” Ata Tuna Ciftlik, co-founder and CEO of Lunaphore Technologies, told BioWorld. The amount of the transaction was not disclosed. This acquisition is expected to close in the third quarter of 2023.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.
The U.S. CMS posted a draft rule for home health payments for calendar year 2024, but the agency is not out of the woods yet with the established rule for CY 2023. The National Association for Homecare & Hospice (NAHC) announced July 6 that it has filed a lawsuit in the District Court for the District of Columbia seeking a reversal of rate cuts imposed by the agency for 2023, the results of which could spill over into the current round of rulemaking for home health payments.
The black box warning appended to the label of Alzheimer’s disease (AD) drug Leqembi (lecanemab) took some on Wall Street mildly aback but failed to surprise others, as analysts mulled what the full approval, granted July 6 by the U.S. FDA, might mean for other developers in the space.
The Association for Accessible Medicines fired off a constitutional challenge in U.S. federal court July 5 to provisions included in Minnesota’s new budget law that would restrict price increases for generic and off-patent drugs.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
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