About AIOMEGA®

AIOMEGA® is a clinician‑centered medical technology company focused on advancing intraoral device therapy through engineered biomechanics, digital precision, and responsible innovation. Our work integrates airway physiology, mandibular biomechanics, and modern manufacturing to support clinicians in delivering safer, more predictable outcomes.

Our mission is to innovate, invent, and bring to market health and fitness devices and methods that fulfill unmet needs while being mindful of cost and complications in healthcare.   

This mission guides every aspect of our development philosophy — from anatomy‑driven design to clinician‑directed machine‑learning frameworks and engineered biomechanics that prioritize safety, clarity, and clinical judgment.

AIOMEGA® blends three pillars:

• Anatomy‑Driven Design — grounded in airway structure, mandibular function, and physiologic patterns.
• Clinician‑Directed Machine‑Learning — SMART‑Rx™ and AIO‑Rx™ provide structured frameworks that support, not replace, clinician evaluation.
• Engineered Biomechanics — device geometry aligned with RAP, RVP, TCT, VMO, and the CONNECTED‑ARC‑OF‑MOTION®.

Our systems never automate device settings, never generate treatment plans, and never replace clinical judgment.

AIOMEGA® maintains a growing portfolio of granted patents and pending applications assigned to Sleep Solutions of Texas, LLC. Our IP covers innovations in:

• Intraoral device geometry
• Mandibular positioning systems
• Digital workflows
• Biomechanical modeling

We disclose only what is published in issued patents; proprietary internal logic and computational rules remain protected.

AIOMEGA® follows a development approach that is informed by established regulatory principles and quality‑system expectations. Our software and workflow tools are designed to support clinicians with structured guidance while avoiding automated decision‑making. Within this framework, we aim to maintain alignment with concepts commonly associated with PDURS‑style documentation, clinical decision support exemptions, and non‑SaMD boundaries as understood in current regulatory discussions.

Our goal is to provide clarity, transparency, and responsible communication so clinicians can understand how our systems are intended to be used, without implying that the software performs evaluation, diagnosis, or treatment planning.

Our development and manufacturing processes follow:

• QMSR 2026 principles
• ISO 13485 alignment
• ISO 10993‑compliant materials
• Documented design controls
• Validated workflows
• Device‑level traceability

This ensures consistency, biocompatibility, and long‑term reliability.

• Clarity over complexity
• Engineering over guesswork
• Clinical judgment over automation
• Safety over shortcuts
• Partnership over isolation

AIOMEGA® was founded by Raghavendra V. Ghuge, MD, DABSM, FAASM, MBA, an adult and pediatric sleep physician with more than 20 years of clinical experience in sleep medicine. Dr. Ghuge combines medical training with engineering‑driven device development and business expertise from the Duke University Fuqua School of Business. His work spans clinical care, invention, intellectual‑property development, and the creation of clinician‑directed digital workflows that emphasize safety, clarity, and responsible innovation.

AIOMEGA® follows a development approach that is informed by established regulatory principles and quality‑system expectations. Our software and workflow tools are intended to support clinicians with structured, geometry‑based guidance while avoiding automated decision‑making or prescriptive outputs.

Within this framework, we aim to remain consistent with concepts commonly referenced in discussions around PDURS‑style documentation, clinical decision support exemptions, and non‑SaMD boundaries. These references are provided for context only and are not intended to imply any specific regulatory designation or classification.

Our goal is to communicate clearly and responsibly so clinicians understand how our systems are intended to be used, without suggesting that the software performs evaluation, diagnosis, or treatment planning.

AIOMEGA®’s digital tools are designed to provide clinicians with structured frameworks — not automated recommendations. SMART‑Rx™ and AIO‑Rx™ organize clinical inputs into reproducible geometric relationships that clinicians may use when forming their own independent assessments.

These tools do not:

• evaluate patient data
• generate treatment plans
• adjust device settings
• determine mandibular positions
• predict outcomes

Clinicians remain solely responsible for all diagnostic and therapeutic decisions.

  The internal logic, decision pathways, and computational rules used by SMART‑Rx™ and AIO‑Rx™ are proprietary and not disclosed; clinicians interact only with the high‑level guidance outputs. Upon request, clinicians may review the conceptual basis of the system as described in AIOMEGA’s issued patents, without revealing the proprietary internal algorithms.

This approach supports transparency while protecting trade secrets and maintaining regulatory boundaries.

AIOMEGA®’s development and manufacturing processes are guided by principles commonly associated with:

• QMSR 2026
• ISO 13485:2016
• ISO 10993
• Documented design controls
• Validated manufacturing workflows
• Device‑level traceability
• Structured post‑market surveillance

These references describe the quality‑system concepts that inform our processes and are not intended to imply certification or formal designation.

AIOMEGA®’s digital ecosystem — including the AIOMEGA® App, Portal, SMART‑Rx™, and AIO‑Rx™ — is intended to:

• support clinician judgment
• organize geometric and physiologic information
• provide structured frameworks
• avoid automation of clinical decisions
• avoid device configuration or control
• avoid predictive analytics

These boundaries are maintained to ensure responsible use and regulatory clarity.

 Device labeling, instructions for use, and patient‑facing materials are developed to reflect:

• intended use
• device limitations
• safety considerations
• clinician responsibilities
• non‑automated workflows

All labeling is reviewed for clarity, consistency, and alignment with quality‑system expectations.

AIOMEGA® maintains structured processes for monitoring device performance, clinician feedback, and field observations. 

These processes support continuous improvement and responsible lifecycle management. 

AIOMEGA® devices are prescription medical devices and must be used under the supervision of a licensed clinician. All diagnostic decisions, treatment planning, and therapeutic adjustments remain solely under clinician authority. Nothing on this website is intended to replace clinical judgment or serve as medical advice.

All device descriptions, engineering summaries, and manufacturing information provided on this site are informational and do not modify or replace the FDA‑cleared Instructions for Use (IFU). In the event of any discrepancy, the IFU and FDA‑cleared labeling take precedence.

AIOMEGA® maintains compliance with applicable FDA regulations, quality‑system requirements, and labeling standards. References to engineering processes, materials, or manufacturing methods are descriptive and do not imply performance claims beyond those supported by the cleared indications for use.