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

FDA clears Owlet Dream Sock for infant pulse oximetry

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 [...]

2024-09-24T21:03:30-05:00November 10th, 2023|Industry|

FDA clears Modius Sleep device for chronic insomnia

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. [...]

2024-09-24T21:05:22-05:00November 1st, 2023|Industry|

Sleepiz One+ bedside monitoring device receives FDA clearance

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. [...]

2024-09-24T21:06:42-05:00October 11th, 2023|Industry|

FDA clears AI-assisted sleep monitoring device Dreem 3S

Beacon Biosignals announced in a press release on Sep. 13, 2023 that it received FDA 510(k) clearance for the Dreem 3S, an artificial intelligence (AI)-assisted wearable headband for sleep monitoring. The device allows patients to participate in home-based electroencephalogram (EEG) data collection. About the [...]

2024-09-24T21:09:16-05:00September 14th, 2023|Industry|

FDA clears circul pro Ring as pulse oximeter

On Sep. 7, 2023, BodiMetrics announced that its circul pro Ring has received FDA 510(k) clearance as a pulse oximeter. According to the company, the device’s form factor and LED technology make it uniquely designed to accurately measure blood oxygen level on people with any skin [...]

2024-09-24T21:10:06-05:00September 9th, 2023|Industry|

FDA approves remedē System for MRI conditional use

On May 24, 2023, Zoll announced the FDA has approved the remedē System for conditional use with magnetic resonance imaging (MRI). The implantable transvenous phrenic nerve stimulation therapy is a treatment for adults with moderate to severe central sleep apnea (CSA). About the [...]

2024-09-24T21:13:02-05:00May 25th, 2023|Industry|
Go to Top