We have hit a huge milestone in our mission to rid the world of obstructive sleep apnea: Our new mmRNA (Modified Mandibular Repositioning Nighttime Appliance) device has officially been granted 510(k) market clearance by the FDA. This device is noninvasive, nonsurgical, and nonpharmaceutical, and it is designed to provide lifelong results by targeting dental tissue anomalies and malformations.
This week, there has been an influx of press about the device as news of clearance becomes available to the public at the perfect time, just as millions of people are searching for efficient alternatives to CPAP after the Philips recall of several of its machines.
One such example is the piece in Medical Device Network, which announced the clearance of the Vivos alternative on August 24, 2021. Thank you for featuring our new device, Medical Device Network! Check it out here to learn more about the FDA clearance of the mmRNA device.