Summary Ensosleep is a cloud-based aritifical intelligence/machine learning platform that analyzes polysomnogram and home sleep testing data to score studies according to AASM scoring criteria. It functions similar to automated scoring algorithms but claims greater accuracy because of ongoing machine learning from very large [...]
Summary The SleepImage System is an FDA-cleared Software As a Medical Device (SaMD) for the assessment of sleep quality and sleep apnea diagnosis. Physiological signals are collected using PPG and accelerometry for one or for multiple nights. The recorded signals are uploaded to its [...]
Summary The Ivy bracelet-type wrist wearable reportedly collects heart rate, respiratory rate, and user-entered data to provide “cardiac coherence,” “readiness score” and “wellness score” (using water intake, exercise, meditation time), activity (steps), sleep duration and quality, and reproductive cycle information. The Wellness library contains [...]
Summary CIRCUL+ is a wearable ring pulse oximeter sensor paired with cloud-based analytic software. It acquires PPG and accelerometry and derives HR, ODI, SpO2, BP, and sleep stages. The new CIRCUL+ device added finger temperature, finger blood pressure, and ECG function. Circul+ is FDA-registered [...]
Summary The Oniris is an adjustable (thermoplastic moldable) oral appliance which is FDA cleared to treat snoring in adults only. An FDA search failed to support FDA clearance or approval for the treatment of adult sleep apnea. However, the website does provide a disclaimer [...]
Summary Homni Smart Sleep Solution is a (portable) bedside nearable device and companion Wellness Coach Sleep app that is meant to assist falling asleep and awakening. The device supports different light wavelengths which can be programmed to facilitate sleep onset and awakening. An added [...]
Summary Go2Sleep is a small (6 grams) ring that tracks SpO2 and HR. Using the signals and a proprietary AI algorithm, it records and provides HR, SpO2, AHI, HRV, Sleep Score, total sleep time, light/deep/REM sleep stages, and a “Toss and Turn” score. The [...]
Summary Itamar Medical’s WatchPAT 300 device is a FDA-cleared (Class 2 device for Ventilatory Effort and recorder). The newer (disposable probe) WatchPAT ONE was cleared 6/5/19 based on predicate comparison with the previously cleared WatchPAT 300. WatchPAT is a Type 3 portable home sleep [...]
Summary There are several Wesper iterations. Wesper has two self-adhesive patches containing sensors are placed on the body: one below the right breast and one below the umbilicus. The older version tracked sleep “metrics,” provided reports, and enabled consultation with a sleep specialist (PhD [...]
Summary Genio system received FDA granted Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate (9/21/21). It consists of an implanted stimulator and an external piece which is applied nightly [...]