FDA clears DentiTrac system

Braebon Medical announced that the DentiTrac oral-appliance compliance system has been cleared by the U.S. Food and Drug Administration (FDA) for use with the SomnoDent oral device.

The DentiTrac system is a wearable microrecorder and Web cloud portal combination for the objective measurement of oral appliance compliance for sleep apnea. The microrecorder is embedded inside an oral appliance to gather detailed information to confirm that a patient is following prescribed therapy. The information is uploaded to the Braebon cloud portal where it can be reviewed and assessed.

The system is only available from SomnoMed in the U.S., according to Braebon.

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