Huxley Medical's SANSA Receives Diagnostic ECG Clearance from FDA, Paving Way for First Solution to Systematically Detect Arrhythmias During Home Sleep Testing

ATLANTA, Dec. 18, 2025 /PRNewswire/ -- Huxley Medical, Inc. announced the SANSA® home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, making SANSA the first home sleep apnea test capable of offering diagnostic insight into cardiac arrhythmias, such as atrial fibrillation, from a single chest-worn patch.

This regulatory milestone positions the SANSA platform at the intersection of cardiology and sleep medicine, two specialties with significant patient overlap and rising demand for home testing.

"SANSA has simplified access to home sleep apnea testing while providing cardiac insights that can identify patients who may benefit from longer-term monitoring, intervention, or both," said Jodie Hurwitz, MD, of the North Texas Heart Center and former president of the Heart Rhythm Society. "As electrophysiologists and cardiologists focus on addressing modifiable risk factors like sleep apnea to optimize outcomes, this efficient workflow will improve value, help expedite therapy, and become a complementary tool for cardiologists to enable guideline-directed care at scale."

"The rapid shift to home sleep apnea testing has dramatically improved access and cost-effectiveness for patients. However, the electrocardiographic (ECG) assessment provided by lab polysomnography has been lost in that transition," said Dr. Ravi Aysola, Clinical Professor and Director of Sleep Medicine at UCLA Center for Sleep Medicine. "SANSA's patch form factor and ECG channel, combined with its function as a 9-channel home sleep apnea test, restore and streamline these capabilities with actionable ECG strips rather than proxy signals. With this clearance, sleep medicine practitioners will increasingly be able to identify arrhythmias in routine practice and enable earlier intervention by routing them to appropriate cardiology care."

Building on previously published investigational data, Huxley, in collaboration with physician investigators, will share real-world data employing SANSA for the detection of arrhythmias during sleep apnea testing at upcoming electrophysiology meetings.  "This marks our fourth FDA clearance in six quarters as we continue to expand SANSA's functionality," said Brennan Torstrick, PhD, Chief Scientific Officer of Huxley. "This milestone in particular is a landmark step for multi-diagnostic use and sets our team up well to continue executing our clinical and technology strategy in 2026."

Media Contact
Brennan Torstrick, PhD
Chief Scientific Officer
Huxley Medical
[email protected]

About Huxley Medical
Huxley Medical, Inc. creates diagnostic solutions that make care more accessible for patients. The company holds proprietary expertise in biosensor development, physiological signal analysis, and artificial intelligence. In partnership with clinician customers, Huxley is on a mission to streamline care for any patient, anywhere. To learn more, visit huxleymed.com or email [email protected]. 

SOURCE Huxley Medical, Inc.