AIOMEGA expands AIO Breathe prescribing precision

AIOMEGA said clinicians can now document a posterior-leaning flange angle greater than 90 degrees for its AIO Breathe mandibular repositioning device. The update stays within the device’s existing FDA-cleared design and does not change its geometry, features or adult indications for snoring and mild to moderate obstructive sleep apnea.

Why it matters: - The change gives clinicians a more precise way to prescribe and describe AIO Breathe without altering the device’s FDA-cleared design. - AIOMEGA says the clarification could improve documentation consistency for mandibular repositioning therapy.

What happened: - AIOMEGA, a Texas biomedical company, announced on Sept. 18, 2026 that clinicians prescribing AIO Breathe may document a posterior-leaning flange angle greater than 90 degrees. - The company said the option falls within the device’s existing FDA-cleared posterior-leaning flange design. - The update does not change the device’s geometry, features or indications.

The details: - AIO Breathe is an FDA-cleared mandibular repositioning device for adults with snoring or mild to moderate obstructive sleep apnea. - The adult device uses separate custom-fabricated upper and lower intraoral trays that fit over the teeth. - The trays require at least eight maxillary and eight mandibular teeth. - The device is made with additive manufacturing technology and biocompatible materials based on intraoral scans and a 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 prescribed anterior advancement. - Mandibular plateaus on the lower tray guide the jaw downward to create additional anterior airway space. - AIOMEGA says the flanges and plateaus help maintain mandibular advancement while allowing natural tongue migration. - The Connected Arc of Motion™ mechanism is designed to guide the mandible anteriorly as the mouth opens, helping maintain forward positioning during jaw rotation. - The device permits anterior, vertical and lateral jaw movement. - The design is intended to maintain an open airway and increase air exchange by advancing the mandible and tongue during opening, closing and lateral movement. - The FDA-cleared adult indications are to reduce or alleviate snoring and mild to moderate obstructive sleep apnea while sleeping. - Additional clarifications state AIO Breathe is for adults 18 and older. - The device is prescription only and must be used under the supervision of a qualified clinician. - AIO Breathe does not include or require a morning repositioner.

Between the lines: - The announcement appears aimed at tightening how clinicians describe an already cleared configuration, rather than adding a new product feature. - AIOMEGA is positioning the device around precision and airway mechanics in a treatment category where fit and jaw positioning can matter for clinical use. - The release also leans on broader clinical context around obstructive sleep apnea, including sleep fragmentation, oxygen desaturation, daytime sleepiness and cardiometabolic stress.

What's next: - Clinicians can now use the updated angle specification when documenting AIO Breathe prescriptions. - AIOMEGA said the posterior-leaning flange angle specifications are protected by issued and pending U.S. patents. - The company identified the inventor as Raghavendra Ghuge and the assignee as Sleep Solutions of Texas, LLC.

The bottom line: - AIOMEGA is not changing AIO Breathe’s cleared design; it is giving clinicians a more exact way to document one of its existing configurations.