FDA Clears Novel Device for Snoring and Sleep Apnea
The FDA has granted Signifier Medical Technologies De Novo approval for its novel eXciteOSA device for reducing snoring and mild obstructive sleep apnea in adults.
The prescription-only device is the first approved by the agency for use while awake to help improve tongue muscle function. The device can help over time to prevent the tongue from collapsing backwards and obstructing the airway while the patient is asleep.
The daytime therapy works by providing electrical muscle stimulation through a mouthpiece that sits around the tongue. For the first six weeks, patients use the device once a day in a 20-minute session, followed by once-weekly sessions afterward.