The U.S. FDA reported July 11 a class I recall for patient return electrodes used during electrosurgical procedures that may burn the patient with sufficient severity to induce a third-degree burn. More than 21,000 of the electrodes, made by Raritan, N.J.-based Ethicon Inc.’s Megadyne division, are subject to the recall, although the agency said the manufacturer is still conducting a root cause analysis of the issue.
Five long years after the publication of the now-notorious Katsanos paper, the U.S. FDA has issued a final determination about whether devices indicated for treatment of peripheral artery disease carry the threat of excess mortality when using paclitaxel as an antiproliferative.
Cymedica Orthopedics Inc. is relaunching its wearable knee pain relief treatment under the Motive Health Inc. brand, following U.S. FDA clearance for direct-to-consumer (DTC) use. The muscle stimulating Motive Knee band is now available without a prescription for anyone suffering from knee pain.
U.S. FDA clearance of Mobi pumped up Tandem Diabetes Care Inc. on Tuesday. The miniaturized insulin pump is indicated for individuals with diabetes, aged 6 years and up, with the FDA action boosting Tandem’s share price from $26.41 to $29.20 in morning trading before falling back to $27.12 by the end of the day.
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for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.
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.
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.
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.
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
Leadless cardiac electrophysiology devices have been around for a while now, but Abbott Laboratories of Abbott Park, Ill., has managed to beat the competition in the market for dual chamber pacing via two leadless devices. The company reported July 5 that the U.S. FDA has approved the Aveir DR, a two-unit device configuration that provides pacing for both the right ventricle and the right atrium and which some analysts believe helps to make Abbott shares an underappreciated asset for investors.
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