Tag: Huxley Medical
Huxley Medical receives FDA approval for SANSA sleep test for CSA
December 18, 2025HME News Staff
ATLANTA – Huxley Medical, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for central sleep apnea (CSA) detection for its SANSA home sleep apnea test. The FDA clearance follows the presentation of SANSA clinical performance data at the SLEEP meeting earlier this year. The data, collected from 325 patients across 7 clinical sites, compared SANSA's scoring algorithm versus gold-standard polysomnography and demonstrated 100%...
Huxley Medical HST approved for cellular data capabilities
February 7, 2025HME News Staff
ATLANTA – Huxley Medical, a commercial-stage medical technology firm focused on streamlining detection of sleep and heart disorders, has received clearance from the U.S. Food and Drug Administration for its SANSA home sleep apnea test to begin using cellular data upload capabilities. The company says this breakthrough eliminates the need for Bluetooth pairing or smartphone apps commonly required to transmit test data to physicians, addressing a common source of failed home testing, while simplifying...