Huxley Medical Launches FDA-Cleared Device for Central Sleep Apnea Detection and Appoints New Medical Director
Huxley Medical, Inc. made a groundbreaking announcement today regarding its recent approval from the U.S. Food and Drug Administration (FDA) for the 510(k) clearance of its central sleep apnea detection device, SANSA®. This commercially launched home sleep apnea test is set to redefine patient care in sleep medicine, ensuring easier access to crucial diagnostic services. The announcement also included the appointment of Dr. Nancy A. Collop as the Medical Director of Sleep Medicine, a significant addition to the team that is expected to drive forward clinical innovation in the field.
The FDA clearance comes in light of the promising SANSA clinical performance data presented earlier this year at the SLEEP meeting. This robust study evaluated data from 325 patients spanning seven clinical sites. Through this data, SANSA's advanced scoring algorithm was shown to possess an impressive 100% sensitivity and 99% specificity in identifying central sleep apnea (CSA), classified by a central apnea index of 10 or more. These results accentuate SANSA's potential, particularly in diagnosing conditions that often accompany cardiovascular issues, such as heart failure and atrial fibrillation.
Dr. Rami Khayat, who is the Director of Sleep Services at Penn State, remarked on the critical nature of distinguishing between central sleep apnea and obstructive sleep apnea, stating, "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." Huxley Medical’s Chief Scientific Officer, Brennan Torstrick, PhD, further emphasized the uniqueness of SANSA, noting that few home sleep tests have received FDA approval to differentiate between the two forms of apnea.
Utilizing cutting-edge artificial intelligence techniques to analyze physiological signals related to CSA, SANSA's performance enables healthcare professionals to confidently select it as an appropriate diagnostic tool. This technology offers strong clinical performance, building upon extensive validations performed across diverse clinical settings and patient demographics.
In conjunction with the announcement, Dr. Nancy Collop joins Huxley Medical's executive team as Medical Director of Sleep Medicine. With a storied career aimed at enhancing patient care, Dr. Collop previously served as the Director of the Emory Sleep Center and has held the presidency at the American Academy of Sleep Medicine (AASM). Her involvement with AASM on task forces related to home sleep testing underlines her aptitude for guiding the clinical and technological strategies that Huxley aims to adopt. "I am pleased to join Huxley Medical and support its mission to deliver more actionable and accessible diagnostic tools," she stated.
Dr. Collop will play an instrumental role in steering SANSA’s development, aiming to further advance the innovation within the domain of sleep medicine. Her extensive editorial experience in the Journal of Clinical Sleep Medicine will significantly contribute to research and knowledge dissemination in this field. Huxley's CEO, Chris Lee, expressed gratitude for Dr. Collop's leadership, stating, "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."
In essence, Huxley Medical's introduction of the SANSA test represents a pivotal moment in sleep medicine by enhancing diagnostic accuracy and patient management capabilities. The FDA's clearance not only validates the clinical importance of this technology but underscores Huxley’s commitment to facilitating improved patient outcomes in the realm of sleep health.
The FDA clearance comes in light of the promising SANSA clinical performance data presented earlier this year at the SLEEP meeting. This robust study evaluated data from 325 patients spanning seven clinical sites. Through this data, SANSA's advanced scoring algorithm was shown to possess an impressive 100% sensitivity and 99% specificity in identifying central sleep apnea (CSA), classified by a central apnea index of 10 or more. These results accentuate SANSA's potential, particularly in diagnosing conditions that often accompany cardiovascular issues, such as heart failure and atrial fibrillation.
Dr. Rami Khayat, who is the Director of Sleep Services at Penn State, remarked on the critical nature of distinguishing between central sleep apnea and obstructive sleep apnea, stating, "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." Huxley Medical’s Chief Scientific Officer, Brennan Torstrick, PhD, further emphasized the uniqueness of SANSA, noting that few home sleep tests have received FDA approval to differentiate between the two forms of apnea.
Utilizing cutting-edge artificial intelligence techniques to analyze physiological signals related to CSA, SANSA's performance enables healthcare professionals to confidently select it as an appropriate diagnostic tool. This technology offers strong clinical performance, building upon extensive validations performed across diverse clinical settings and patient demographics.
In conjunction with the announcement, Dr. Nancy Collop joins Huxley Medical's executive team as Medical Director of Sleep Medicine. With a storied career aimed at enhancing patient care, Dr. Collop previously served as the Director of the Emory Sleep Center and has held the presidency at the American Academy of Sleep Medicine (AASM). Her involvement with AASM on task forces related to home sleep testing underlines her aptitude for guiding the clinical and technological strategies that Huxley aims to adopt. "I am pleased to join Huxley Medical and support its mission to deliver more actionable and accessible diagnostic tools," she stated.
Dr. Collop will play an instrumental role in steering SANSA’s development, aiming to further advance the innovation within the domain of sleep medicine. Her extensive editorial experience in the Journal of Clinical Sleep Medicine will significantly contribute to research and knowledge dissemination in this field. Huxley's CEO, Chris Lee, expressed gratitude for Dr. Collop's leadership, stating, "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."
In essence, Huxley Medical's introduction of the SANSA test represents a pivotal moment in sleep medicine by enhancing diagnostic accuracy and patient management capabilities. The FDA's clearance not only validates the clinical importance of this technology but underscores Huxley’s commitment to facilitating improved patient outcomes in the realm of sleep health.
Topics Health）
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