BodiMetrics’ FDA-cleared circul pro™ ring, paired with EnsoSleep PPG advanced AI/ML analysis, offers accessible, comfortable home sleep testing
MADISON, WI – December 3, 2024 – BodiMetrics, a leader in well-being and fitness monitoring devices, announces a partnership with EnsoData, a pioneer in healthcare AI, to power BodiMetrics’ FDA-cleared circul pro™ smart ring with the FDA-cleared EnsoSleep PPG software as a medical device (SaMD) to increase affordability and accessibility of home sleep apnea testing and longitudinal sleep monitoring.
The collaboration between BodiMetrics and EnsoData aims to expedite the patient care journey from initial home testing to longitudinal therapy monitoring. The accuracy, comfort and flexibility of the circul pro™ ring, coupled with EnsoSleep PPG software, provides clinicians across the medical spectrum with an anytime, anywhere sleep diagnostic and ongoing monitoring solution.
With over a decade of development and more than five years of commercial history BodiMetrics’ devices offer a proven track record of high-quality clinical use in sleep diagnostics, remote patient monitoring, veterans’ care and clinical trials. The circul pro™ smart ring features sensor stabilization technology (SST), a spring loaded and tapered design, to eliminate movement and slippage and ensure an optimal fit to collect the highest acuity data for patients of all skin tones, ensuring health equity across all populations.
As EnsoData’s third FDA clearance for an SaMD in sleep medicine, EnsoSleep PPG provides AI sleep scoring and analysis of the data collected by FDA-cleared pulse oximetry devices. The algorithm was validated by comparing results of PPG-based testing against simultaneously recorded PSGs, demonstrating strong accuracy in detecting sleep disordered breathing events, identifying sleep stages, and determining total sleep time. With this partnership, clinics will have the option of incorporating the circul pro™ ring for sleep testing with the accuracy and reliability of EnsoSleep PPG AI-powered diagnosis.
The partnership offers an affordable and scalable solution to test patients at home and across multiple nights. Research shows that missed diagnoses of OSA in home testing can be as high as 10% of patients across nights. That is why multi-night testing is so important, as highlighted by Dr. Meir Kryger, MD, FRCPC, Professor Emeritus of the Yale School of Medicine and Chief Scientific Advisor of BodiMetrics.
“Episodic and spot measurements of sleep data may miss the times when oxygen levels change quickly during sleep in some conditions. This leaves patients at risk of misdiagnosis,” said Dr. Kryger. “However, when devices can continuously measure oxygen saturation during sleep over multiple nights and AI can analyze that data, you can improve patient outcomes rather dramatically.”
Brock Hensen, COO of EnsoData, added:
“This partnership is another significant advancement in expanding patient access to quality sleep testing and patient monitoring. We are excited to launch this collaboration with BodiMetrics and further expand the EnsoData ecosystem of partnerships with the circul pro™ ring. Simple, accessible options like this will ultimately be the way we address sleep apnea at scale,” said Hensen.
To learn more about the collaboration, visit www.ensodata.com/partners-bodimetrics.
About BodiMetrics: BodiMetrics is dedicated to empowering consumers and patients alike with products, services, and solutions that will allow them to take charge of their healthcare, lower overall costs, and improve their well-being. All BodiMetrics products are tested by independent third-party labs to clinical standards as well, where indicated, approved by the FDA. For more information, visit https://circul.health/ by https://bodimetrics.com.
About EnsoData: EnsoData is a healthcare technology company that uses artificial intelligence (AI) and machine learning (ML) technology to connect sleep disorder diagnosis to therapy, simplifying and accelerating the sleep care pathway for both physicians and patients.
About EnsoSleep PPG: Cleared by the FDA in 2024, EnsoSleep PPG accelerates the identification, diagnosis, and treatment of sleep disordered breathing with accurate, cost-effective, AI-driven analysis of photoplethysmogram (PPG) signals captured by pulse oximeters, all displayed in a single, cloud-based platform. For more information, visit ensodata.com.
