AIOMEGA adds pediatric prescription precision for AIO Breathe

AIOMEGA says clinicians treating children ages 6-17 can now document a posterior-leaning flange angle greater than 90 degrees in its prescribing tools for the FDA-cleared AIO Breathe device. The company also launched AIO Breathe Academy to train clinicians on pediatric use, growth-conscious replacement and documentation.

Why it matters: - AIOMEGA is trying to give pediatric sleep clinicians more precise documentation for mandibular repositioning therapy without changing the FDA-cleared AIO Breathe device. - The update is aimed at children ages 6-17 with snoring or mild to moderate obstructive sleep apnea, a condition tied to disrupted sleep and developmental risks. - The company is pairing the documentation change with training tools that address craniofacial growth, replacement timing and prescription workflows.

What happened: - AIOMEGA announced that clinicians prescribing AIO Breathe may document a posterior-leaning flange angle greater than 90 degrees in the company’s SMART Rx and AIO Rx documentation tools. - The option applies to the device’s cleared posterior-leaning flange design and does not change the device’s geometry, features or indications. - AIOMEGA also introduced AIO Breathe Academy, a clinician education program for the pediatric device. - The announcement was made in Tyler, Texas, on Sept. 21, 2026.

The details: - AIO Breathe is an FDA-cleared mandibular repositioning device for children ages 6-17 with snoring or mild to moderate obstructive sleep apnea. - The device uses separate custom-fabricated upper and lower intraoral trays that fit over the teeth and require adequate dentition for retention. - The trays are produced with additive manufacturing technology and biocompatible materials suitable for intraoral use, based on intraoral scans and the dentist’s prescription. - Right and left protrusive flanges on the upper tray engage vertical flanges on the lower tray to reposition the mandible based on the prescribed anterior advancement. - Mandibular plateaus on the lower tray guide the mandible downward to create additional anterior airway space. - The design is intended to maintain mandibular advancement while allowing natural tongue migration. - The Connected Arc of Motion mechanism guides the mandible anteriorly as the mouth opens, including during jaw rotation. - The device permits anterior, vertical and lateral jaw movement. - AIO Breathe is intended to maintain an open airway and increase air exchange by advancing the mandible and tongue during opening, closing and lateral movement. - The pediatric instructions for use say the device may not be modified as the child grows and must be replaced to accommodate craniofacial growth and development. - AIO Breathe does not include or require a morning repositioner. - The company says the Academy provides structured education on the cleared posterior-leaning flange design and prescriptive precision options, including documenting a posterior-leaning flange angle greater than 90 degrees. - The Growth Conscious Replacement System offers dentists training tools to custom order devices that accommodate craniofacial growth and development in children ages 6-17. - AIOMEGA says growth and development create unique challenges in pediatric OSA, and the company is supporting clinicians with education, training and precision-guided workflows. - AIOMEGA is a Texas-based biomedical company developing airway and sleep health technologies, including AIO Breathe. - The posterior-leaning flange angle specifications referenced in the release are covered by issued and pending U.S. patents assigned to Sleep Solutions of Texas, LLC and invented by Raghavendra Ghuge. - The company listed contact information at More information.

Between the lines: - The launch appears designed to standardize how clinicians document a configuration already covered by the cleared device, which can reduce ambiguity in prescriptions and records. - The focus on replacement as children grow underscores that pediatric oral devices cannot be treated like one-time fittings. - The training push suggests AIOMEGA wants clinicians to use the device within a tightly defined workflow rather than as a generic sleep-apnea appliance.

What's next: - Clinicians using AIO Breathe can now pair the device with the updated SMART Rx and AIO Rx documentation options. - The Academy and Growth Conscious Replacement System are positioned to support ongoing prescribing and replacement decisions as pediatric patients grow. - AIOMEGA appears to be building a broader pediatric treatment ecosystem around the device, training and documentation tools.