In a major step bringing cutting edge technology to patient care, the US Food and Drug Administration has confirmed that it has approved Proteus Digital Health's ingestible sensors that transmit data, such as whether patients are taking pills regularly and their vital signs, to medical professionals.
The sensor, sold under the brand name Ingestion Event Marker (IEM), has already been approved in Europe and can be ingested by placing it in a capsule. IEM draws its power from stomach fluid and sends data to a patch attached to the user's stomach.
The data includes whether the user is taking medicine on time and vital signs such as heart rate, body activity and position. This data is then sent to the user's medical caregiver through a mobile phone app.
Stating that the company is delighted with the approval, Proteus Digital Health co-founder and CMO Dr George Savage said, "We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe. We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings."