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# Huxley Gains Clearance for At-Home Apnea Test
- URL: https://www.fdaweb.com/huxley-gains-clearance-for-at-home-apnea-test/
- Published: 2024-08-08T12:00:00.000Z
- Updated: 2026-09-14T14:37:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157538

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.