Drugs

Huxley Gains Clearance for At-Home Apnea Test

FDA has cleared a Huxley Medical 510(k) for its at-home sleep apnea diagnostic patch, Sansa. “Unlike current patches, rings, watches, or finger probes, Sansa does not require additional attachments, wires, belts, or hoses,” the company says. “Its patented combination of sensors and materials precisely measures eight physiological channels including blood oxygen saturation, EKG [electrocardiogram]-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy.”

The chest-worn patch uses advanced signal processing and artificial intelligence to detect “sleep-disordered breathing” while also providing an electrocardiogram (EKG) channel to record electrical signals from the heart, Huxley says.

The company says the clearance is based on clinical trial data from 533 patients across seven U.S. sites, which demonstrated the device’s efficacy in measurement reliability and performance for use in diagnosing mild, moderate, and severe sleep apnea.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome