Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On May 6, 2024, Masimo announced it received FDA approval of Stork, its baby monitoring system that provides parents and caregivers visual and audible alarms if an infant’s pulse rate (PR) and oxygen saturation (SpO2) readings fall outside of preset ranges. About Masimo Stork [...]
On April 29, Philips announced its first quarter results and announced it has reached an agreement to resolve the personal injury litigation and the medical monitoring class action in the U.S. According to a progress update report from the company, the settlement addresses approximately [...]
Philips Respironics announced it has reached a final agreement with the U.S. Food and Drug Administration (FDA) and U.S. Department of Justice (DOJ) regarding the consent decree proposed earlier this year. The consent decree with the U.S. government comes nearly three years after [...]
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 [...]