FDA Clears iNOS Intraoral Biosensor for Sleep Apnea
The FDA has cleared a new intraoral biosensor that treats mild to moderate obstructive sleep apnea while continuously monitoring blood oxygen levels.
The U.S. Food and Drug Administration has granted 510(k) clearance to the iNOS intraoral biosensor. This prescription device from Achaemenid LLC is designed to reduce snoring and treat mild to moderate obstructive sleep apnea in adults while providing continuous physiological monitoring.
According to a release from the company, the device integrates a hermetically sealed, medical-grade pulse oximeter into an oral appliance. It continuously tracks the functional oxygen saturation of arterial hemoglobin, known as SpO2, throughout the night. Founder Reza Radmand, DMD, FAAOM, stated, "The future of sleep apnea therapy is no longer just treating the airway-it’s continuously monitoring the physiology behind the treatment."
How the Device Works
The biosensor is embedded in an upper or lower dental arch. It uses red, green, and infrared light directed through perfused oral soft tissue to detect arterial pulses and measure blood oxygen levels.
The device operates on a rechargeable 3.7V lithium-ion battery, which provides about eight hours of use per charge. Data is transmitted in real-time via encrypted Bluetooth to a companion Android application for healthcare professionals to review. If the Bluetooth connection is lost, the device's firmware can buffer up to 30 minutes of data locally.
Availability and Intended Use
The iNOS is cleared as a reusable, single-patient device. It is approved for use in several settings, including sleep labs, long-term care facilities, hospitals, and home environments.
The company plans a soft launch for the device in October of this year. Full commercial availability is expected in the first quarter of 2027.
Technical Specifications
The source report provides key technical details for the newly cleared device.
| Feature | Specification |
|---|---|
| FDA Clearance | 510(k) |
| Primary Function | Treat snoring & mild/moderate OSA; monitor SpO2 |
| Battery Type | Rechargeable 3.7V lithium-ion |
| Battery Life | ~8 hours per charge |
| Data Buffer | 30 minutes of local storage |
| Data Transmission | Encrypted Bluetooth to Android app |
| Commercial Launch | Full availability Q1 2027 |
The device represents a combination therapy and monitoring approach for sleep-disordered breathing. It aims to allow clinicians to review both sleep quality and the effectiveness of the oral appliance therapy remotely through the collected data.
