The chest-worn sleep apnea diagnostic patch measures eight physiological channels with a single point of contact.
RT’s Three Key Takeaways:
- FDA Clearance: Huxley Medical’s SANSA, a chest-worn sleep apnea diagnostic patch, received FDA 510(k) clearance.
- Innovative Design: The SANSA patch measures eight physiological channels without additional attachments and is validated against polysomnography.
- Clinical Validation: Trials demonstrated SANSA’s high accuracy, sensitivity, and patient comfort, with effective performance across all skin tones.
Huxley Medical, a developer of technologies that streamline cardiopulmonary care, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its chest-worn sleep apnea diagnostic patch, SANSA.
With this clearance, Huxley Medical can move forward to market its device.
The patch is an at-home, single-point-of-skin-contact diagnostic device that does not require additional attachments, wires, belts, or hoses.
Its patented combination of sensors and materials measures eight physiological channels: blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy.
The chest-worn patch utilizes advanced signal processing and artificial intelligence to detect sleep-disordered breathing while simultaneously providing an electrocardiogram (EKG) reference channel to record electrical signals from the heart.
“Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes,” says Chris Hallett, Huxley Medical’s co-founder and chief commercial officer, in a release.
The announcement is the latest milestone for the company, which has raised more than $20 million in investment capital and grant funding since its founding in 2019.
“From my prior experience developing programs to engage sleep physicians and cardiologists, I know first-hand the difficulties in getting patients with sleep apnea and comorbid arrhythmias diagnosed and managed,” Hallett says in a release. “SANSA will begin to eliminate these barriers for physicians and patients.”
Clinical Validation
The SANSA platform has already undergone a clinical trial involving 533 patients across seven US sites, including the University of Pennsylvania, the University of Michigan, Emory University, and Atrium Health Wake Forest Baptist. SANSA has demonstrated its efficacy in measurement reliability and performance for use in diagnosing mild, moderate, and severe sleep apnea.
The clinical trial provided data supporting SANSA’s safety and effectiveness, including:
- High accuracy, sensitivity, and specificity in sleep apnea detection compared to in-lab sleep tests;
- Improved patient compliance and comfort due to its non-invasive nature;
- Excellent performance on all skin tones for diverse patient management, which had been a challenge in the past.
“As electrophysiologists, we are already quite comfortable in using patch-based EKG monitors for arrhythmia monitoring,” says Suneet Mittal, MD, chair of Valley Health System’s Cardiovascular Service Line as well as director of electrophysiology, in a release. “The ability to diagnose sleep apnea using the same platform using the SANSA device represents an exciting opportunity to manage two diseases that often co-exist, namely atrial fibrillation and sleep apnea.”
Douglas Kirsch, MD, past president of the American Academy of Sleep Medicine and medical director of Atrium Health Sleep Medicine, adds in a release, “It’s excellent news for the sleep community that Huxley’s SANSA device has been cleared by the FDA to evaluate obstructive sleep apnea at all severity levels with reliable performance across all skin tones. This eight-channel wearable patch, including an EKG sensor, should be easy for patient self-application and improve the experience for diagnosis of obstructive sleep apnea.”
Photo caption: SANSA
Photo credit: Huxley Medical
