DormoTech NLab

The DormoTech Nlab is a wearable physiological data recorder that collects sleep study signals including EEG, eye movement, airflow, heart rate, oxygen saturation, respiratory effort, snoring, and body position from multiple sensor units (head, chest, abdomen, and leg/arm). It transmits data wirelessly to a central processing unit and then to cloud servers for analysis by FDA-cleared polysomnography software. The device is intended for patients age 6 and older in both hospital and home sleep study environments.

The Nlab uses the same fundamental sensor array technology as the predicate Nox T3, collecting signals from head-worn and body-worn units via Bluetooth to a central unit. A key difference is that the Nlab integrates a plethysmograph (PPG) SpO2 sensor directly into the head unit, whereas the predicate requires a separate SpO2 sensor. The Nlab also adds a leg/arm/chest ExG unit not present in the predicate. All components are wearable and portable with detachable/replaceable sections for reusability between patients.

ISO 14155 (clinical investigation of medical devices), ISO 80601-2-61 (pulse oximetry), ISO-10993 (biocompatibility), IEC electrical safety standards, and electromagnetic compatibility standards. Testing included biocompatibility, software verification and validation, electrical safety, EMC compliance, and product requirements verification.

Clinical data from 26 pediatric subjects (ages 6+) showed no significant differences in primary endpoints (AHI) or secondary endpoints (ODI, snore, sleep stages, position) between the Nlab and gold-standard PSG, with mean differences near zero and narrow limits of agreement. The integrated SpO2 sensor was clinically validated across 12 diverse subjects with RMSE of 2.53%, meeting ISO 80601-2-61 accuracy standards, with no systematic differences by skin pigmentation or sex. The sensor array design, placement (head/thorax/limb), and underlying technology are identical to the predicate despite the integrated SpO2 and added ExG functionality.