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DormoTech unveils FDA-cleared wireless sleep diagnostics platform

June 19, 2025
in Sleep Info
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DormoTech launched DormoVision X, a wi-fi, AI-powered house sleep testing platform, in the course of the SLEEP 2025 annual assembly in Seattle. The system is being marketed below a brand new title however is predicated on the DormoTech Nlab system, which acquired FDA clearance in December 2024.

About DormoVision X

DormoVision X is a cloud-based sleep diagnostics platform that permits distant administration of each in-lab and residential polysomnography. The system streams real-time physiological knowledge and data 29 direct channels and 9 derived indicators. It’s self-applied and doesn’t require set up or nasal cannulas.

The platform features a cell app to information sufferers by way of the sleep take a look at and permits clinicians to watch research remotely. Based on DormoTech, the system is designed for prolonged monitoring over a number of nights and is suitable with all sleep research sorts.

The system was cleared by the U.S. Meals and Drug Administration below the title “DormoTech Nlab.” The clearance applies to make use of in sufferers age 6 and older in each supervised and unsupervised environments. Based on the FDA documentation, the system features a wearable headband with sensors for EEG, EOG, airflow, Sp02, coronary heart price and loud night breathing, together with belts measuring respiratory effort and physique place, an ExG unit with three electrodes, and a central unit to obtain, retailer and transmit knowledge.

A validation research printed in Sleep and Respiratory discovered settlement between the system and conventional polysomnography in measurements of AHI severity and complicated sleep stage scoring.

DormoTech stories that the platform is constructed for seamless integration with the brand new house PSG CPT codes. The system consists of AI-supported knowledge evaluation and a customizable reporting module.

Learn extra trade information from the AASM.



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Tags: DiagnosticsDormoTechFDAclearedplatformsleepUnveilswireless
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