EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high quality, accessible, and cost-effective approach to diagnosing sleep disorders, including sleep apnea.
Sleep apnea is a highly prevalent but often undiagnosed condition that exacerbates cardiovascular diseases like high blood pressure and congestive heart failure, neurodegenerative diseases like Alzheimer’s, metabolic disorders including diabetes, stroke, and more. It is estimated that over 29.4 million Americans have sleep apnea, with more than 80% of cases still undiagnosed.
With early and accurate diagnosis of sleep apnea, clinicians can help prevent complications and reduce healthcare expenses, not only saving lives but also having a profound impact on healthcare economics.
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