Wearable Chest Sleep Apnea Test Receives FDA Clearance

The Food and Drug Administration (FDA) has granted 510(k) clearance to SANSA (Huxley Medical, Atlanta, GA), a sleep apnea patch that is worn on the chest. SANSA is an at-home, single-point-of-contact diagnostic device that does not require additional attachments such as belts, wires, or hoses. The device uses artificial intelligence (AI) and advanced signal processing to detect disordered breathing during sleep, record EKG signals from the heart, and provide other biophysical parameters that can be used by clinicians in their evaluation of potential sleep-related breathing disorders in adults suspected of having sleep apnea.

SANSA was cleared based on data from a clinical trial that included 533 participants with mild, moderate, or severe sleep disordered breathing across 7 sites in the United States. Results from the clinical trial demonstrate that SANSA was accurate in detecting sleep apnea.

• The sensitivity of SANSA in sleep apnea detection was 88.2% (95% CI, 81.3 to 93.2).
• The specificity was 87.3% (95% CI, 82.1 to 91.5).
• The device was shown to perform well regardless of participant skin tone.

"It's excellent news for the sleep community that Huxley's SANSA device has been cleared by the FDA to evaluate obstructive sleep apnea at all severity levels with reliable performance across all skin tones," said Douglas Kirsch, MD, former president of the American Academy of Sleep Medicine and Medical Director of Atrium Health Sleep Medicine. "This 8-channel wearable patch, including an EKG sensor, should be easy for patient self-application and improve the experience for diagnosis of obstructive sleep apnea."