The US Food & Drug Administration (FDA) has cleared Huxley Medical’s Sansa home sleep apnoea test to begin using cellular data upload capabilities.

Huxley is a commercial-stage medical technology firm based in Atlanta, Georgia, and focused on streamlining detection of sleep and heart disorders. This breakthrough 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 alike.

“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,” said Brennan Torstrick, Huxley chief scientific officer. “Simultaneously, it eliminates a common practical headache for patients: the need to download a phone app and pair devices over Bluetooth. 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 tester.”

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 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 apnoea diagnostics,” said Cathy Goldstein, lead author of a peer-reviewed study on Sansa published in the Journal of Clinical Sleep Medicine (jcsm.aasm.org/doi/10.5664/jcsm.11522), and a professor at the University of Michigan. “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 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 apnoea testing easier and more accessible for both patients and providers.”

Huxley Medical (huxleymed.com) is a privately held medical technology company developing products and services that streamline care for any patient anywhere. The company has received funding from the National Science Foundation, National Institutes of Health, Georgia Research Alliance Venture Fund, Invest Georgia, Georgia Tech Foundation Research Impact Fund, and Duke Capital Partners.