EnsoData receives clearance for AI-powered sleep diagnosis
By HME News Staff
Updated 9:20 AM CST, Tue February 20, 2024
MADISON, Wis. – EnsoData has received 510(k) clearance from the Food and Drug Administration for AI-driven analysis of PPG signals (EnsoSleep PPG) which supports the diagnosis of sleep disorders using any FDA-cleared pulse oximeter. EnsoSleep, EnsoData's previously FDA-cleared diagnostic AI analysis and sleep scoring solution, uses machine learning to analyze data from traditional sleep studies to aid physicians in diagnosing sleep disorders. With this new clearance, EnsoSleep PPG will provide more opportunities for clinicians to effectively reach an undiagnosed patient population by enabling AI-driven analysis using the photoplethysmogram (PPG) signals recorded by pulse oximeters. “Expanding EnsoData’s capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep disordered breathing events, including sleep apnea,” said Justin Mortara, president and CEO of EnsoData. “With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions.” By lowering the barrier for patients to receive an accurate sleep test to more widely available pulse ox devices, clinicians can expedite the diagnostic process and provide patients with answers to their health problems more quickly, says EnsoData.
- Listen to Justin Mortara talk about using AI to make health care better
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