On March 27, 2024, Beacon Biosignals announced it received FDA 510(k) clearance for SleepStage ML, its artificial intelligence (AI)/machine learning (ML) software that analyzes polysomnography (PSG) recordings and automatically scores sleep stages. About SleepStage ML According to a press release from the company, SleepStage [...]

On Feb. 20, 2024, EnsoData announced it received FDA 510(k) clearance for technology that enables artificial intelligence (AI)-powered sleep diagnosis using FDA-cleared pulse oximetry devices. About EnsoSleep PPG EnsoSleep PPG enables AI-driven analysis using photoplethysmogram (PPG) signals recorded by compatible FDA-cleared pulse oximeters. [...]

On Feb. 20, 2024, X-trodes announced the FDA has granted 510(k) clearance for its Smart Skin solution, a new wireless wearable technology for advanced electrophysiological monitoring. About X-trodes Smart Skin X-trodes’ Smart Skin is comprised of dry-printed multi-modal electrode patches that conform to the [...]

Masimo announced it received FDA clearance of MightySat Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available over-the-counter direct to consumers without a prescription. About MightySat Medical MightySat Medical is a direct-to-consumer option for a medical device with hospital-grade pulse [...]

On Feb. 9, 2024, Samsung Electronics announced the sleep apnea feature on the Samsung Health Monitor app received De Novo authorization from the FDA. About the Galaxy Watch sleep apnea feature Using a compatible Samsung Galaxy Watch and Phone, the new feature will [...]

Compumedics announced on Dec. 4, 2023, that its Somfit home sleep test received FDA 510(k) clearance to be marketed in the U.S. About Somfit The Somfit system is a non-invasive prescription device intended for home use with patients suspected to have sleep-related breathing disorders. [...]

On Nov. 29, 2023, Vivos Therapeutics announced it received FDA 510(k) clearance for its line of Complete Airway Repositioning and/or Expansion (CARE) oral appliances for the treatment of severe obstructive sleep apnea (OSA). About Vivos CARE oral appliances Vivos’ removable CARE oral appliances represent [...]

On Nov. 9, 2023, Owlet announced it received De Novo clearance from the FDA for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants. The device provides infants’ real-time health information to parents and caregivers. About the Owlet Dream Sock According [...]

Neurovalens announced Oct. 31 it has received FDA 510(k) clearance for its Modius Sleep device intended to treat chronic insomnia. By delivering a small and safe electrical pulse to the head for 30 minutes before bed, Modius Sleep is designed to improve insomnia. [...]

Sleepiz received FDA Class II 510(k) clearance for Sleepiz One+, a contactless device intended to measure heart rate and respiration rate in adult patients at rest or during sleep. About Sleepiz One+ Sleepiz One+ uses Doppler radar technology to provide passive vital signals. [...]