11/15/2025
AIOMEGA™ Receives Pediatric Clearance for AIO Breathe®—Expanding Innovative Sleep Apnea Treatment to Children
Tyler, Texas – November 06, 2025 – AIOMEGA, a Texas biomedical company, today announced that the U.S. Food & Drug Administration (FDA) has granted clearance for the pediatric use of its flagship device, the AIO Breathe®, in children and adolescents with mild to moderate obstructive sleep apnea (OSA). The pediatric version features identical design, engineering, and therapeutic technology as the adult device—offering a seamless adaptation to the pediatric patient population.
“As a company committed to advancing airway and sleep health across the lifespan, we are thrilled to make AIO Breathe available to younger patients,” said Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM, the Founder and Chief Executive Officer of AIOMEGA. “Obstructive sleep apnea in children is often under‑recognized yet carries profound implications—from impaired neurocognitive development and growth delays to cardiovascular and metabolic disturbances.”
Studies estimate prevalence in the general pediatric population at approximately 1 %–4 %. (Frontiers) In practice, the risks are even higher among children with craniofacial abnormalities, neuromuscular disorders, or obesity. (Dove Medical Press).
Dr. Ghuge continued, “With clearance of the pediatric version of AIO Breathe, we are now positioned to offer a novel, non‑invasive airway enhancement solution that may fill a critical gap in pediatric sleep‑disordered breathing management. Our goal is to support improved sleep, growth, behavior, and cardiovascular wellness for children impacted by OSA.”
About AIO Breathe (Pediatric Version)
The pediatric version of AIO Breathe maintains the same patented AAVOAT (Adaptive Antero-Vertical Open Airway Therapy) design that gives the adult version clearance and is optimized in size for children. Key features include:
● Non‑invasive oral‑airway-enhancement device engineered to reduce airway collapsibility during sleep
● FDA‑cleared indication for children (ages 6 to 11) and adolescents (ages 12 to 17) with mild to moderate obstructive sleep apnea
● Seamless compatibility with existing clinical workflows (already in use for adults)
● Backed by AIOMEGA’s mission to integrate sleep‑medicine innovation into everyday health and performance.
Clinical and Market Implications
Pediatric OSA is associated with a spectrum of adverse conditions, including impaired cognitive performance, behavioral dysfunction, growth faltering, and elevated cardiovascular risk. (MDPI) Historically, treatment options have centered on surgery (e.g., adenotonsillectomy) and positive airway pressure modalities such as CPAP; yet a significant portion of children either fail first‑line therapy, are non‑adherent, or remain untreated. With FDA clearance for pediatric use, AIO Breathe provides sleep medicine specialists, otolaryngologists, pediatric pulmonologists, and dentists a new therapeutic option for children with obstructive sleep apnea.
About AIOMEGA
Founded by Dr. Raghavendra V. Ghuge, a board‑certified physician in sleep medicine, AIOMEGA is a biotech company dedicated to the health and well-being of every person on the planet by engineering and patenting solutions for true MEGA airway performance in sleep and sport. The company’s product portfolio includes AIO Breathe, AIO Breathe MB, AIO Swift, AIO Grit, AIO Brut, and AIO Revive.
