FDA OKs Huxley Medical’s Simultaneous ECG & Sleep Apnea Diagnostic

Huxley Medical, developer of tech to streamline cardiopulmonary care, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SANSA chest-worn sleep apnea diagnostic patch.
 
The patch is an at-home diagnostic device with a single point of contact on the skin. It doesn’t require additional attachments, wires, belts, or hoses.
 
Its sensors and materials measure blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position, and actigraphy. According to the company, SANSA the first, only FDA-cleared chest-worn patch that uses advanced signal processing and AI to spot sleep-disordered breathing while providing an EKG reference channel to record the heart’s electrical signals.
 
“Our SANSA technology offers healthcare providers a cutting-edge tool to enhance diagnostic accuracy and patient outcomes,” said Chris Hallett, Huxley Medical’s co-founder and chief commercial officer. 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.

More data on the SANSA platform

SANSA has undergone a 533-patient clinical trial at seven sites. Data demonstrated measurement reliability to diagnose mild, moderate, and severe sleep apnea.
 
High accuracy, sensitivity, and specificity were found in spotting sleep apnea compared to in-lab sleep tests. Its non-invasive nature was shown to improve patient compliance and comfort.
 
SANSA also showed excellent performance on all skin tones, which has been a challenge in the past.
 
“As electrophysiologists, we are already quite comfortable in using patch-based EKG monitors for arrhythmia monitoring,” said Dr. Suneet Mittal, Chair of Valley Health System’s Cardiovascular Service Line as well as director of electrophysiology. “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.”