Huxley Medical acquires FDA clearance for its sleep apnoea diagnostic patch

Huxley Medical has received FDA 510(k) clearance for its SANSA sleep apnea diagnostic patch. This innovative, chest-worn device simplifies the diagnosis of sleep apnea, a condition linked to serious health issues. As a first-of-its-kind at-home diagnostic tool, SANSA requires no additional attachments, belts, wires, or hoses.

The patch uses a patented sensor combination to monitor eight physiological parameters: heart rate (EKG-derived), blood oxygen saturation, chest movement, respiratory effort, sleep staging, body position, snoring, and actigraphy. This clearance positions SANSA as the only FDA-approved chest-worn patch utilizing advanced signal processing and AI.

The SANSA technology, evaluated in a clinical trial with 533 patients across seven US sites, including the University of Michigan and Emory University, demonstrated high reliability and performance in diagnosing sleep apnea. The device’s non-invasive design enhances patient comfort and compliance, contributing to its effectiveness and accuracy. Huxley Medical is now poised to market the device, offering a cutting-edge tool for improved diagnostic accuracy and patient outcomes.