Home sleep apnea test receives FDA clearance

Home sleep apnea test receives clearance: ©Onephoto - stock.adobe.com

Huxley Medical announced that the FDA has cleared the SANSA home sleep apnea test to begin using cellular data upload capabilities. This eliminates the need for Bluetooth pairing or smartphone apps commonly required to transmit test data to physicians, addressing a common source of failed home testing, while simplifying the diagnostic process for patients and providers, according to the company.

"Cellular-enabled SANSA paves the way for sleep physicians and technicians to receive data in near real-time once a test is complete, enabling more efficient workflows and accelerating time to care. Simultaneously, it eliminates a common practical headache for patients: the need to download a phone app and pair devices over Bluetooth," said Brennan Torstrick, Huxley president and chief scientific officer, in a statement. "This clearance is an important milestone to expand access to home sleep testing and adds another differentiating feature to SANSA. We are proud to offer the only hands-free, wire-free, and app-free test solution."

SANSA's initial FDA clearance in 2024 validated accuracy against gold-standard polysomnography in a 340-patient clinical trial conducted at seven institutions. The test uniquely combines nine physiological channels—including oximetry, respiratory effort, sleep/wake staging, and a reference electrocardiogram (ECG)—into a single chest-worn patch, enabling expanded insights into cardiopulmonary health.

"These are exciting milestones in the field of sleep apnea diagnostics," said Cathy Goldstein, MD, lead author of a peer-reviewed study on SANSA published in the Journal of Clinical Sleep Medicine. Goldstein, a professor at the University of Michigan Sleep Disorders Center, added, "The test was carefully designed to simplify workflows, and its integration of unique signals like ECG along with AI makes it especially useful for managing complex cases. Now the ability to use built-in cellular upload further distinguishes SANSA from other tests by accelerating our ability to diagnose while eliminating a common practical headache for patients when testing at home."

Since initial clearance, SANSA has been adopted by key opinion leaders through a controlled launch to validate end-to-end operations. "The initial feedback has been overwhelmingly positive, and we are grateful to our early adopters for their continued partnership," said Chris Hallett, Huxley co-founder and chief commercial officer. "We look forward to expanding SANSA's availability to more patients in the coming months, as we continue our mission to make sleep apnea testing easier and more accessible for both patients and providers."