Proteus Digital Health has scored another FDA clearance for its Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence, making it the only device with an FDA-sanctioned claim for measuring medication adherence.

It is estimated that 50% of people don’t take their medicines as prescribed, potentially limiting the therapeutic effectiveness of the medicine and resulting in $100-300 billion in avoidable healthcare costs in the US. There have been many efforts to address this challenge but no products have previously been cleared by the FDA for aiding in the measurement of adherence until now.

The Ingestible Sensor was approved by the FDA in 2012 and communicates with an adhesive patch, worn on the torso.“We are delighted that our collaborative work with the FDA continues to enable positive progress,” said Proteus Co-Founder and Chief Medical Officer Dr. George Savage. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”

When used with a medication, the Proteus Ingestible Sensor marks actual intake time, which is a quantifiable event that has allowed regulators to grant the expanded indication to the company.

The Ingestible Sensor was approved by the FDA in 2012 and communicates with an adhesive patch, worn on the torso. The Proteus Patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile app via Bluetooth.