The FDA has given 510(k) clearance to Huxley Medical's sleep apnea diagnostic patch, SANSA.
The device is an at-home diagnostic tool that uses signal processing technology and AI to measure "blood oxygen saturation, EKG-derived heart rate, respiratory effort, chest movement, sleep staging, snoring, body position and actigraphy," according to an Aug. 7 news release from Huxley Medical.
The designation clearance allows Huxley to market the device in the U.S.