Sleep apnea device earns FDA clearance

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

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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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