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Latest EnsoData FDA Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices

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 […]

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Sunrise Receives FDA Clearance for At-Home Sleep Apnea Test

Sunrise, announced the U.S. Food and Drug Administration (FDA) has cleared for use of its second-generation at-home sleep apnea test that uses artificial intelligence (AI) to aid in the diagnosis of obstructive sleep apnea and sleep-related breathing disorders. The Sunrise team is using a novel way to measure sleep through […]

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GE Healthcare Receives FDA Clearance for First X-Ray AI to Help Assess ET Tube Placement

GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on […]

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Circadiance Added to SleepGlad AI Mask Fitter Formulary

Circadiance’s SleepWeaver masks are now on the SleepGlad formulary, a mask selection tool driven by artificial intelligence to help PAP patients find the perfect fit on the first try. This partnership puts Circadiance’s SleepWeaver PAP masks onto the SleepGlad mask formulary. SleepGlad is the world’s first remote, 3D-scanning PAP/NIV mask fitter, requiring no […]

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New EnsoSleep FDA Clearance Includes Total Sleep Time for HSATs, Pediatric Scoring & Web-Based Platform

EnsoData announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, a leading AI-assisted sleep scoring solution. With a substantial clinical study size, EnsoSleep’s validation metrics support diagnostic accuracy, helping sleep labs and healthcare systems provide care more efficiently and improve patient outcomes across the globe. […]