The US Food and Drug Administration (FDA) has cleared the SANSA home sleep apnea test to begin using cellular data upload capabilities, eliminating the need for Bluetooth pairing or smartphone apps to transmit test data to physicians.
Huxley Medical now touts a hands-free, wire-free, and app-free test solution. “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,” says Brennan Torstrick, Huxley president and chief scientific officer, in a release. “This clearance is an important milestone to expand access to home sleep testing and adds another differentiating feature to SANSA.”
SANSA’s initial FDA clearance in 2024 validated accuracy against 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.
“These are exciting milestones in the field of sleep apnea diagnostics,” said Cathy A. 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, says in a release, “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 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,” says Chris Hallett, Huxley co-founder and chief commercial officer, in a release. “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.”
