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 [...]
Summary The Fisher Wallace Stimulator, a cranial electrical stimulator (CES) headband, has been used to treat insomnia, anxiety, and depression. It was previously known as the LISS Cranial Stimulator which was FDA cleared in 1990 to treat insomnia and/or anxiety, and the company is [...]
Summary There are both adult (Restore 1 and 2) and pediatric (Rest Go, Rest 2nd gen, Rest + 2nd gen) Hatch products. All are (sound, light, and alarm) nearables with apps. Hatch Restore 1 offers music, sounds, stories, mind/body exercises, bedside lighting, and light [...]
Summary URGOnight consists of a wearable EEG headband connected to an app via Bluetooth. URGOnight has two dry measuring electrodes over the sensorimotor cortex in positions C3 and C4, with reference and ground positioned on the left and right mastoids. The headband EEG data [...]
Summary Modius Sleep is a prescription headset for adult insomnia treatment. It resembles a headband across the top of the head, with wires which are applied over the mastoid bone bilaterally. Users are recommended to sit in a chair at approximately 8-9pm (bedtime 1-5 [...]
