Industry Articles
Updates about sleep-related diagnostic devices, therapies, products and companies
On Sept. 9, 2024, Withings announced that it received FDA 510(k) clearance for its Sleep Rx mat, a contactless device for diagnosing obstructive sleep apnea (OSA). About Sleep Rx Sleep Rx is an under-the-mattress device intended to aid in the diagnosis of OSA [...]
On Aug. 28, 2024, OxiWear announced it received FDA 510(k) clearance for its oxygen data collection device, an ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO2) and pulse rate. About the OxiWear System The OxiWear System is a [...]
In March 2024, the AASM hosted a webinar featuring an interactive panel discussion addressing uncertainties stemming from the announcement by Philips Respironics that it is discontinuing various sleep and respiratory care devices in the U.S. The discussion also addressed the consent decree between Philips, the [...]
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 [...]