Huxley Medical Announces Commercial Launch of FDA-Cleared Central Sleep Apnea Detection and Appointment of Medical Director of Sleep Medicine

ATLANTA, Dec. 17, 2025 /PRNewswire/ -- Huxley Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and commercial release of central sleep apnea (CSA) detection for its SANSA® home sleep apnea test. 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.

Central Sleep Apnea Clearance

The FDA clearance follows the presentation of SANSA clinical performance data earlier this year at the SLEEP meeting. The study, drawing on 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."

"Few home sleep apnea tests are FDA cleared to differentiate central from obstructive sleep apnea," said Huxley Chief Scientific Officer, Brennan Torstrick, PhD. "By applying artificial intelligence to the hallmark physiological signals of CSA, we deliver strong clinical performance. Our extensive validation across multiple clinical sites and a diverse patient population further expands SANSA's multi-diagnostic capabilities and gives physicians even more confidence to choose SANSA for determining the most appropriate path to treatment."

Dr. Nancy Collop to Serve as Medical Director of Sleep Medicine

As Medical Director of Sleep Medicine, Dr. Nancy 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."

Dr. Collop has chaired multiple foundational AASM taskforces on home sleep testing, including the development of the organization's formative clinical guidelines and technology evaluations. She currently serves as Editor Emeritus of the AASM's flagship journal, the Journal of Clinical Sleep Medicine, and the Section Editor of Sleep Medicine for Up-To-Date.

"Dr. Collop has been a champion for patient-first innovation for decades and has fundamentally shaped the field of sleep medicine," said Chris Lee, PhD, Chair and CEO of Huxley. "Her contributions to SANSA's development have been instrumental. We are honored that she will take on an expanded role as we continue working to streamline care for any patient, anywhere."

Media ContactBrennan Torstrick, PhDChief Scientific OfficerHuxley Medical[email protected]

About Huxley Medical Huxley Medical, Inc. creates diagnostic solutions that make care more accessible for patients. The company holds proprietary expertise in biosensor development, physiological signal analysis, and artificial intelligence. In partnership with clinician customers, Huxley is on a mission to streamline care for any patient, anywhere. To learn more, visit huxleymed.com or email [email protected]. 

SOURCE Huxley Medical, Inc.