FDA approves AI-based at-home sleep test
By HME News Staff
Updated 10:08 AM CST, Thu February 16, 2023
NAMUR, Belgium – Sunrise has received U.S. Food and Drug Administration (FDA) clearance for its second generation at-home sleep apnea test that uses artificial intelligence (AI) to diagnose obstructive sleep apnea and sleep-related breathing disorders. The technology captures Mandibular Jaw Movements (MJM) with one point of contact - a lightweight sensor placed on the chin that records the jaw’s movements. Data is collected through an app, analyzed with an algorithm using AI and made available to health care providers through a secure online portal. “We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing,” said Laurent Martinot, CEO and co-founder of Sunrise. New features on the at-home sleep apnea test include the ability for patients to complete multi-night testing.
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