Huxley Medical receives FDA approval for SANSA sleep test for CSA

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% sensitivity and 99% specificity for the detection of CSA (defined as central apnea index ≥10). "While less common than obstructive sleep apnea, central sleep apnea is more prevalent in patients with cardiovascular disease such as heart failure and atrial fibrillation," said Rami Khayat, MD, director of Sleep Services at Penn State, who presented the validation study results. "Accurately distinguishing between these conditions is critical, as it can significantly alter treatment decisions. This is an exciting step that will help clinicians stratify and manage patients more efficiently." The company also announced that Nancy A. Collop, MD, former director of the Emory Sleep Center and past president of the American Academy of Sleep Medicine (AASM), has joined Huxley as medical director of Sleep Medicine. In her new role, Collop will help guide the company's clinical and technology development strategy. "I am pleased to join Huxley Medical and support its mission to deliver more actionable and accessible diagnostic tools," said Dr. Collop. "My career has focused on advancing innovation in patient care, and I believe SANSA has significant potential to further evolve the field of sleep medicine."