Proteus Digital Health announced Thursday that its latest generation of Ingestible Sensor technology gained expanded FDA approval, "enabling the device to be used as an aid in the measurement of adherence." The company indicated "this is the only device with an FDA-sanctioned claim" for this indication.
Proteus' chief medical officer George Savage remarked "we believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings."
The company explained that the sensor, when used with medication, is able to mark actual intake time, "a quantifiable event that has allowed regulators to grant the expanded indication." The sensor, which initially gained FDA approval in 2012, communicates with an adhesive patch worn on the torso. The device maker added that the "Proteus Patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile app via Bluetooth."
In 2010, Proteus signed an agreement with Novartis to develop sensor-based pharmaceuticals.
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