#USA #Atlanta #Sleep Apnea #Huxley Medical #SANSA Test

Huxley Medical's Breakthrough in Sleep Apnea Testing

Huxley Medical, a pioneering medical technology firm, has made a significant stride in the realm of sleep and heart disorder diagnostics with its recent announcement regarding the SANSA home sleep apnea test. On February 5, 2025, the company unveiled that the U.S. Food and Drug Administration (FDA) has granted clearance for SANSA to utilize cellular data upload capabilities, a development set to transform the patient experience and healthcare provider workflows.

Enhancing Accessibility and Efficiency

One of the primary challenges faced by patients undergoing home sleep testing has been the requirement for Bluetooth pairing or smartphone applications to transmit data. These steps not only add complexity to the process but are also often points of failure that could lead to inconclusive results. Huxley's SANSA test directly addresses these issues by allowing data to be uploaded securely through cellular networks. This means that once a test is concluded, healthcare providers can receive information in near real-time, facilitating more effective and timely diagnoses.

Brennan Torstrick, Huxley's President and Chief Scientific Officer, remarked, "The cellular-enabled SANSA not only empowers sleep physicians and technicians by streamlining workflows but also alleviates common burdens placed on patients. Our aim was to create the only hands-free, wire-free, and app-free solution on the market, and we believe that this FDA clearance marks a crucial step towards broader access to home sleep testing."

Proven Clinical Efficacy

This latest development follows SANSA's initial FDA clearance in 2024, which validated its accuracy against established polysomnography methods through a clinical trial involving 340 patients across seven institutions. The SANSA test is designed to collect a robust data set by integrating nine physiological channels into a single chest-worn patch. These channels monitor vital indicators such as oximetry, respiratory effort, sleep stages, and a reference electrocardiogram (ECG), providing comprehensive insights into a patient's cardiopulmonary health.

Dr. Cathy Goldstein, a leading expert in sleep disorders and a professor at the University of Michigan, underscored the importance of SANSA's design in simplifying workflows. She stated, "The integration of unique signals like ECG along with artificial intelligence enhances the test's utility, particularly in managing complex cases. With the addition of cellular upload capabilities, SANSA distinguishes itself further from other testing methods by accelerating diagnostics while removing burdens on patients."

Future Prospects for SANSA

Following its recent clearance, SANSA has begun to gain traction within the medical community. The product has been initially adopted by select healthcare leaders in a controlled launch aimed at validating operational processes. Early feedback has been overwhelmingly positive, indicating strong satisfaction among early users.

Chris Hallett, Co-Founder and Chief Commercial Officer of Huxley Medical, expressed gratitude towards the early adopters, emphasizing the company's commitment to expanding SANSA's reach. "The initial feedback has been encouraging, and we are eager to extend SANSA's availability to more patients soon, continuing our mission to simplify and improve access to sleep apnea diagnostics."

About Huxley Medical

Huxley Medical, Inc. is a privately held entity dedicated to enhancing patient care through innovative medical technologies. The company is supported by various funding sources, including the National Science Foundation and the National Institutes of Health, as it seeks to broaden its technological offerings. For further information regarding their services or products, visit huxleymed.com.