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 [...]

Summary The NTX100 Nidra (bilateral leg) device is a novel technology which uses high-frequency, low-level electrical stimulation to provide tonic motor activation (TOMAC) of the leg peroneal nerve(s). The leg bands (worn below the knees over the fibular heads all night) allow for self-delivery [...]

Summary The Hapbee products emit ultra-low radio frequency energy (ulRFE) to reproduce low-power electromagnetic signals the company refers to as “biostreams.” These biostreams were developed from previously recorded magnetic signals using a SQUID magnometer, and claim to replicate the effects melatonin, caffeine, nicotine, CBD, [...]

Summary Masimo Sleep™ uses a single-use disposable, lightweight, adhesive fingertip sensor tethered to a wrist strap (Radius PPG™) to obtain up to 7 nights of sleep monitoring. Each kit also includes a reusable chip ot transmit data, however the sensor and strap are discarded [...]