Belgian sleep-focused digital health startup Sunrise has received FDA 510(k) clearance for its home sleep apnea test that's placed on a user's chin at night.
The Sunrise technology fits into a single point of contact 8-gram sensor and offers results available within minutes. The sensor analyzes bio-signals from mandibular jaw movements, which can help calculate respiratory disturbance often found in sleep apnea patients. It also evaluates airflow and oximetry during sleep to aid in diagnosing sleep-related breathing disorders and sleep apnea.
Results are then sent to an AI-enabled app that analyzes the data, which users can share with a healthcare provider via an online portal.
Professional sleep apnea tests often involve overnight monitoring at a sleep center, but recently, home testing companies are emerging that allow patients to test for this disorder at home.
In 2021, a UK-based wearable medical device company Acurable's AcuPebble SA100 received FDA 510(k) clearance. The device senses, records and interprets physiological signals, like a patient's respiratory pattern, while they sleep to prescreen for obstructive sleep apnea.
Along the same lines, South Korea has approved its first digital therapeutics (DTx) solution to treat insomnia. The software as a medical device (SaMD) app, Aimmed’s Sommz, relies on a cognitive behavioural therapy (CBT) approach that has been put through its paces in clinical trials conducted within South Korea.
The app was among a crop of digital therapeutics that were reviewed via a new process for innovative medical devices that was introduced last year and provides a framework for assessing and approving artificial intelligence (AI), big data, and digital health technologies.
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