Summary: The US FDA has granted 510(k) clearance to a contactless, under-the-mattress device designed to aid in the diagnosis of obstructive sleep apnea (OSA). The device is clinically validated for home screening, using sensors to monitor sleep, breathing, and cardiovascular … [Read more...]
FDA Clears Prescription Digital Insomnia Therapeutic SleepioRx
Summary: The US Food and Drug Administration (FDA) has cleared SleepioRx, a digital therapeutic developed by Big Health for the treatment of chronic insomnia. SleepioRx employs cognitive behavioral therapy for insomnia (CBT-I) to address the cognitive and behavioral factors that … [Read more...]
FDA Clears Vyvo’s LifeWatch Wellness Tracker that Rewards Users
Summary: Vyvo Smart Chain has received FDA 510(k) clearance for its wearable health and wellness tracking device, LifeWatch. This device promotes a user-centric health monitoring model and leverages Decentralized Physical Infrastructure network technology to enable users to … [Read more...]
FDA Clears Snap’s Next-Gen Wearable Home Sleep Test
Summary: Snap Diagnostics has received FDA 510(k) clearance for its new wearable home sleep testing device, the Sleep Apnea Monitor (SAM) Model 9-10000. This next-generation device is designed to be smaller, easier to set up, and offers enhanced diagnostics compared to its … [Read more...]
FDA Clears EEG Brain Monitoring Headset
Summary: The US Food and Drug Administration has granted 510(k) clearance to Zeto Inc’s next-generation electroencephalography (EEG) brain monitoring device, ONE, for use in various settings including hospitals, homes, ambulances, and air transport. The device, which features 21 … [Read more...]
Vivos Gains After FDA Clears Oral Appliances for Severe OSA
Summary: According to the Vivos Therapeutics fourth-quarter and total-year 2023 report, there has been beneficial momentum considering the fact that the Food and drug administration clearance of its Treatment oral appliances for severe OSA in grownups. This momentum is evidenced … [Read more...]
FDA Clears Beacon Biosignals’ Autoscoring Software
Crucial Factors: The software program was formulated centered on intensive information from hundreds of thousands of hours of slumber experiments, exhibiting efficiency on par with or excellent to human industry experts in scientific validation checks. It is the very first … [Read more...]