Summary Achaemenid is developing 3 novel intra-oral technologies: (1) The rechargeable intra-oral biosensor is incorporated into a custom mandibular advancement device (MAD). According to the company, proof of concept studies have validated the intra-oral biosensor’s ability to provide PPG, p/ox, HR, and multi-axis movement [...]
Summary AcuPebble SA100 is FDA cleared for OSA pre-screening, and AcuPebble OX100 is FDA cleared to aid in OSA evaluation. AcuPebble SA100 is an FDA-cleared type II device (7/6/21) for “prescreening patients for OSA.” AcuPebble SA100 includes: (1) a proprietary sound sensor, attached to [...]
Summary Cadwell offers 3 ApneaTrak models as described in the Claimed capabilities. ApneaTrak claims to allow viewing of respiratory waveforms and claims to record up to three 8 hour nights of data on one battery charge. ApneaTrak reportedly uses the same software as Cadwell [...]
Summary The Accusom device was FDA cleared for Novasom (now bankrupt) in 2011. Serenity claims to manufacture the Accusom device. In addition to direct physician ordering, Serenity offers enhanced sleep management solutions for providers and offers direct-to-patient programs. It is unclear if clinicians are [...]
Summary The Cradlewise Smart Crib is a combination crib and bassinet which purports to identify and intervene (with crib bouncing/ rocking) upon infant arousals. This device uses a proprietary 3D camera with sensor array and microphone to detect signs of infant arousal. Parents can [...]
Summary The ARES claims to be a prescription type III home sleep apnea device that records up to 3 nights. The unicorder is held on the forehead using a headband which also attaches a nasal canula. A respiratory belt is optional. The patient downloads [...]
Summary The Cerebra Sleep System is capable of collecting data required for Level 2 home PSG and Level 3 HSAT studies. Mailed to the patient’s home, the Cerebra Sleep System includes video instructions for patients to self-apply sensors to the forehead, head, chest, abdomen, [...]
Summary SleePATh is a companion app for the WatchPAT HSAT. SleePATh app presents 3 sets of questionnaires to the user: the intake questionnaire, the bedtime (pre-study) questionnaire, and the morning (post-study) questionnaire. The intake questionnaire includes a full set of sleep history questions, not [...]
Summary Per FDA clearance information, SleepCheckRx provides the user with a binary outcome of either minimal to mild risk (AHI < 15) or moderate to severe risk for OSA (AHI > 15) upon test completion. ResApp’s proprietary (questionnaire and sound analysis) software algorithm claims [...]
Summary The Dawn House system includes an adjustable base, mattress, and “biometric health sensors.” The technology behind the Dawn House bed was developed by their parent company, Ergomotion. The adjustable base allows for head, foot, and height adjustment. The head of the bed reportedly [...]