Sleep apnea device earns FDA clearance

Aiomega, a biomedical company based in Tyler, Texas, received FDA clearance for its sleep apnea device.

AIO Breathe treats obstructive sleep apnea by increasing the user's airway during sleep, enabling them to better exchange air, according to a Feb. 28 news release.

The device has right and left protrusive flanges which engage with the two corresponding vertical flanges to reposition the jaw to reflect the anterior mandibular advancement prescribed by a dentist. 

The device was designed by Raghavendra Ghuge, MD, a sleep physician and the founder and CEO of Aiomega.

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