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FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

TYLER, Texas--(BUSINESS WIRE)-- AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.
FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

AIO BREATHE is a “new mandibular repositioning device” designed by Tyler, Texas based Board Certified Sleep Physician Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM. Ghuge is the founder and CEO of AIOMEGA.

“I designed AIO BREATHE, supported by multiple patents, to overcome several shortcomings of conventional oral appliances used for treatment of OSA,” said Dr. Ghuge

AIO Breathe Summary

AIO Breathe acts by increasing the patient’s airway during sleep, improving ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.

AIO Breathe features right and left protrusive flanges that engage with corresponding right and left vertical flanges. This engagement repositions the jaw to reflect the dentist’s prescribed anterior mandibular advancement and is maintained while mouth is open or closed.

Additionally, mandibular plateaus guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw and work together to maintain advancement in open and closed mouth positions.

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