Summary The Bía sleep mask claims to improve sleep by both blocking light and through an overall process of neurofeedback therapy. The Bía app claims to provide access to the neurofeedback features, calming sleep sounds, a sunrise wakeup function, a sleep histogram (awake, light, [...]
Summary Fitbit trackers are activity monitoring devices that track health and wellness data, such as steps, distance, calories burned, heart rate, and sleep. FitBits use a triaxial accelerometer to capture body motion in 3D space, which is then analyzed, with PPG data, by Fitbit [...]
Summary The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device that uses a triaxial accelerometer to acquire and store data while worn during normal activities and/or during sleep. This watch also has a near-body skin temperature sensor and event marker. [...]
Summary The Oxevision software device is FDA cleared (4/3/24) as a software as a medical device (SaMD) to monitor and analyze subject activity/ movement (e.g., position, reading, eating, location), sleep (in bed awake, in bed asleep, out of bed), and physiologic signs (HR, RR) [...]
Summary Truvaga Plus is a consumer handheld vagus nerve stimulator purported to improve sleep quality. Truvaga™ is a general wellness product (and thus does not require FDA evaluation). Its intended users are those with insomnia. No exclusion populations or warnings are posted. The user locates their [...]
Summary Fitbit smartwatches are wearable monitoring devices with advanced smartwatch features. They are designed to help users track their health and fitness goals while also providing notifications, apps, music control, and other features typically associated with a smartwatch. Fitbits track health and wellness data, [...]
Summary Fibion wearables use a small sensor that provides a cloud-based actigraphy monitoring system to deliver 24-hour data about sleep/wake behavior, circadian rhythms, and daytime physical activity. The core sensor is marketed separately for separate activities and uses. Fibion SENS, Fibion Sleep, Fibion Circadian [...]
Summary Sleepiz One+ is a 510(k) FDA cleared (8/18/23) contactless nearable device intended to measure HR, RR, and movement in adult patients at rest or during sleep. It is CE (European) cleared, but not FDA cleared, as an HSAT. It is not indicated for [...]
Summary The FDA previously issued a statement that ozone and UV light products are not approved for consumer cleaning of CPAP accessories (mask, tubing). SoClean 2 and 3 devices underwent an 11/16/23 voluntary recall. The FDA posted an FDA SoClean safety communication (12/4/23) with [...]
Summary Five Alpha-Stim devices have been FDA cleared between 1983-1992. While the two current Alpha-Stim products are not specifically listed on the FDA website, the company website indicates that these are updated versions. Alpha-Stim AID with earclips reportedly treats insomnia, anxiety, and depression. Alpha-Stim [...]