AIOMEGA® announced the first prescribed clinical use of AIO BREATHE® mandibular repositioning device, FDA-cleared for pediatric obstructive sleep apnea (OSA).
TYLER, TX, UNITED STATES, February 3, 2026 /EINPresswire.com/ — AIOMEGA® today announced the first prescription and clinical use of AIO BREATHE®, an FDA-cleared mandibular-lingual repositioning device for pediatric patients with obstructive sleep apnea (OSA), consistent with the device’s cleared Indications for Use.
The milestone follows recent FDA 510(k) clearance authorizing the device for use in appropriately selected pediatric patients within the labeled age range of 6 to 17 years old. The first prescription reflects initial clinical adoption of the device in routine care following clearance.
AIO® BREATHE® is a precision engineered fully customizable Mandibular-Lingual-Palatal advancement appliance, that is not a palatal expander, designed to be prescribed by qualified healthcare professionals and fitted under clinical supervision. It is intended to be used as part of a comprehensive treatment plan for pediatric OSA, in accordance with the cleared labeling. The pediatric version features identical design, engineering, and therapeutic technology as the adult device—offering a seamless adaptation to the pediatric patient population.
“FDA clearance of this device provides clinicians with an additional non-invasive therapeutic option for pediatric patients who meet the labeled criteria,” said Raghavendra Ghuge, MD, MBA, DABSM, FAASM, Founder and CEO of AIOMEGA®. “The first prescription and clinical use of AIO BREATHE® in a patient with pediatric OSA marks an important step in making this FDA-cleared technology available for worldwide clinical use.”
Studies estimate prevalence in the general pediatric population at approximately 1 %–4 %. (Frontiers) In practice, the risks are even higher (as high as 15%) among children with craniofacial abnormalities, neuromuscular disorders, or obesity. (Dove Medical Press).
Dr. Ghuge continued, “With this first prescribed use of the pediatric version of AIO Breathe, we have achieved a major milestone for pediatric OSA management. 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 clinicians provide 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 Titration) design while building TAVMLRD (Total Antero-Vertical Mandibular Lingual Repositioning Device) features seen in the device that give the adult version clearance and is optimized in size and function for children. Key features include:
• Non‑invasive oral‑airway-enhancement device engineered to reduce airway collapsibility and increase airway size during sleep and wake
• FDA‑cleared indication for children (ages 6 to 11) and adolescents (ages 12 to 17) with mild to moderate obstructive sleep apnea
• Sequential devices adjust for growth-related changes
• Seamless compatibility with existing clinical workflows (already in use for adults)
• Adoption of digital technology for airway evaluation
• Mandibular-Lingual-Palatal repositioning protocols
• New CMS guided clinician-led Pediatric-specific follow-up intervals
• Documentation aligned with payer requirements
• Backed by AIOMEGA’s mission to integrate sleep‑medicine innovation into everyday health and performance.
The pediatric and adult versions of AIO Breathe® share the same core design features of AIOMEGA®’s revolutionary AAVOAT™ (Adaptive Antero-Vertical Open Airway Titration).
Clinical and Market Implications
Pediatric OSA is characterized by repeated multi-level obstruction of the airway resulting in airway closure during sleep, oxygen desaturation, increased respiratory effort, sleep fragmentation, sympathetic activation and cardio-metabolic stress.
It 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 the first prescription and clinical use of this FDA cleared medical device for pediatric use, AIO Breathe has provided sleep medicine specialists, otolaryngologists, pediatric pulmonologists, orthodontists and dentists, and pediatric cardiologists and endocrinologists 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 biotechnology 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.
Media Contact:
Advait Ghuge
AIOMEGA LLC
Tel: +1 (903) 787‑7533
Email: [contact@aiomd.com]
Website: https://aiomd.com/
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The AIOMEGA name and design and AIO Breathe are trademarks of AIOMEGA LLC.
Raghavendra V Ghuge
AIOMEGA LLC
+1 903-316-1269
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