Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies

Philips Respironics resolves personal injury claims

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 [...]

2024-05-06T13:39:28-05:00April 30th, 2024|Industry|

Philips Respironics reaches agreement with U.S. government

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 Philips’ [...]

2024-04-11T13:31:58-05:00April 11th, 2024|Featured, Industry|

Beacon Biosignals receives FDA clearance for sleep staging software

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 [...]

2024-04-25T09:03:22-05:00March 28th, 2024|Industry|

EnsoData receives FDA clearance for AI-powered sleep diagnosis using pulse oximeters

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. By [...]

2024-02-23T15:33:24-06:00February 21st, 2024|Industry|

X-trodes receives FDA clearance for ‘Smart Skin’ monitoring

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 [...]

2024-02-27T09:13:50-06:00February 21st, 2024|Industry|

FDA clears first over-the-counter fingertip pulse oximeter

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 [...]

2024-02-27T09:17:30-06:00February 14th, 2024|Industry|

FDA clears home sleep test worn on forehead

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. [...]

2024-02-01T09:39:33-06:00December 5th, 2023|Industry|

FDA clears Vivos oral appliance for severe obstructive sleep apnea

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 [...]

2024-01-09T09:29:48-06:00November 30th, 2023|Industry|
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