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SomnoMed Receives FDA 510(k) Approval for SomnoDent Devices with Wearable Complicance Micro-Recording

22nd June 2015, SomnoMed Limited (SOM:ASX) announced today that it had received FDA approval to commercialize their wearable SomnoDent devices fitted with DentiTrac® Micro-Recorders. SomnoMed is the first and only company in the world to receive FDA clearance to offer the advanced compliance recording feature for their oral devices in the USA.
SomnoMed is partnering with Braebon Medical Corp., maker of the DentiTrac, to introduce SomnoDent with DentiTrac, designed to capture and store compliance data in the cloud for patients undergoing Continuous Open Airway Therapy (COATTM). Until now, compliance data for COAT was only available by way of patients self- reporting their use of the oral device. SomnoDent with a DentiTrac micro-recorder objectively captures patients’ usage of the device on a minute by minute basis. The recorded compliance data is uploaded to a HIPAA secure cloud and can be easily accessed by the physician treating the patient’s condition. Additionally, clinicians can remotely create, view and keep records of patients’ historic compliance data taken in minute intervals during the time the device is worn.
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