The clearance means Huxley Medical’s SANSA can systematically detect cardiac arrhythmias, aiming to restore a key function of in-lab polysomnography.
Key takeaways:
- The SANSA HST received FDA clearance to be used as a diagnostic ECG monitor.
- It can provide diagnostic insight into cardiac arrhythmias, like atrial fibrillation, from a single chest-worn patch.
- The technology aims to restore the ECG assessment capabilities lost in the clinical shift from in-lab polysomnography to home testing.
- This clearance allows sleep medicine practitioners to identify potential arrhythmias and facilitate earlier referrals to cardiology care.
- This is Huxley Medical’s fourth FDA clearance for the SANSA platform in 18 months.
The US Food and Drug Administration (FDA) has granted regulatory clearance to Huxley Medical Inc’s SANSA home sleep test (HST) for use as a diagnostic electrocardiogram (ECG) monitor.
The clearance means the SANSA HST is capable of offering diagnostic insight into cardiac arrhythmias, such as atrial fibrillation, from a single chest-worn patch. This positions the platform at the intersection of sleep medicine and cardiology, two specialties with significant patient overlap.
“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,” says sleep physician Ravi Aysola, MD, clinical professor and director of sleep medicine at UCLA Center for Sleep Medicine, in a release. “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.”
The dual-diagnostic capability is also intended to improve workflows for cardiologists who screen for sleep apnea as a modifiable risk factor.
“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,” says cardiologist Jodie Hurwitz, MD, an electrophysiologist at the North Texas Heart Center and former president of the Heart Rhythm Society, in a release. “As electrophysiologists and [other] 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.”
Huxley plans to share real-world data using SANSA for arrhythmia detection 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,” says Brennan Torstrick, PhD, chief scientific officer of Huxley, in a release. “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.”
