Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Aug. 19, 2024, SoClean announced it received FDA De Novo clearance for the SoClean 3+, a bacterial reduction device for certain compatible CPAP masks and hoses. About SoClean 3+ The SoClean 3+ is a single-patient home-use cleaning device for compatible CPAP masks [...]
On Aug. 12, 2024, Masimo announced that its Masimo W1 medical watch received FDA 510(k) clearance for connectivity, allowing it to be integrated with the company’s telemonitoring solution. About the Masimo W1 watch The Masimo W1 is a medical watch that detects physiological [...]
On Aug. 8, 2024, Big Health announced it received FDA clearance for its digital therapeutic, SleepioRx, for the treatment of chronic insomnia as an adjunct to usual care in adults. About SleepioRx SleepioRx is a prescription device that delivers cognitive behavioral therapy for [...]
On Aug. 2, 2024, Inspire Medical Systems announced it received FDA approval for the Inspire V therapy system. About Inspire V System Inspire upper airway stimulation is used to treat patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate PAP [...]
On Aug. 1, 2024, ReactDx announced the launch of NiteWatch, an FDA-cleared home sleep monitoring device. About NiteWatch NiteWatch is a home sleep test that measures oxygen saturation, photoplethysmogram, pulse rate, airflow, respiratory effort and heart rate variability. It is worn on the [...]
On July 31, 2024, Huxley Medical announced it received FDA 510(k) clearance for its chest-worn sleep apnea diagnostic patch, SANSA. About SANSA SANSA is a wearable device intended for use in recording, analysis and storage of biophysical parameters to aid in the evaluation of [...]
On June 24, 2024, Harmony Biosciences announced FDA approval of its supplemental new drug application (sNDA) for pitolisant (WAKIX) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 and older with narcolepsy. About pitolisant (WAKIX) Pitolisant is a [...]
On May 14, 2024, Oxehealth announced it received FDA 510(k) clearance for its contactless patient monitoring platform, Oxevision. About Oxevision Oxevision is sleep monitoring software that assesses video footage collected by a camera. It is an activity monitor designed to document and analyze physical [...]
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 [...]