Huxley Medical HST approved for cellular data capabilities

By HME News Staff
Updated 8:18 AM CST, Fri February 7, 2025
ATLANTA – Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, has received clearance from the U.S. Food and Drug Administration for its SANSA home sleep apnea test to begin using cellular data upload capabilities. The company says 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 president and 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 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.
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