2 July 2015 - The US Food and Drug Administration has expanded the indications for the latest generation of US-based medical device maker Proteus Digital Health, Inc.'s Ingestible Sensor technology, enabling the device to be used as an aid in the measurement of medication adherence, the company said on Thursday.

Proteus said it believes this is the only device with an FDA-sanctioned claim for measuring medication adherence.

When used with a medication, the Proteus Ingestible Sensor marks actual intake time, 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.

As many players enter the wearables space, Proteus Digital Health said it is leading a new ingestible category in order to derive unprecedented insights about medication-taking behaviour and physiologic response to therapy.

Proteus said its Digital Medicine therapy includes drugs that communicate when they've been taken, wearable sensors that capture physiologic response, applications that support patient self-care and physician decision making, and data analytics to serve the needs of doctors and health systems.

The goal of Digital Medicines is to empower patients and their families, enable physicians and health systems to more effectively manage risk and ensure that outcomes are reliably achieved.

Proteus received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices.