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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arctic Vision, Biophytis, Hemogenyx, Iovance, Marker, Myopax, Sensorion, Spinogenix.
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Changzhou Biowin, Getinge, Motive Health, Shineco.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 28 Bio, Bioarctic, Epicentrx, Ichnos, Ips Heart, NS, Transcenta.
The U.S. FDA’s draft guidance for patient-matched guides for orthopedic surgical implants is presumably a much-needed document for makers of these guides, and bench testing may suffice for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.
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