Proteus Digital Health has announced it has received FDA clearance for an ingestible sensor, according to a news release.
The ingestible sensor, formally referred to as the Ingestion Event Marker, can be integrated into an inert pill or other ingested products, such as pharmaceuticals. The company said it can serve to identify the time, identity and characteristics of what a person swallows, as well as heart rate, body position and activity. This information is transferred through the user's body tissue to a patch worn on the skin that detects the signal. The patch relays the data captured to a mobile phone application. The information captured can be shared with caregivers and clinicians.
"We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe," said Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health, in the release. "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."
Proteus Digital Health is headquartered in Redwood City, Calif.
Related Articles on FDA Clearances:
Covidien Receives FDA Clearance for Bedside Patient Monitoring System
Siemens Receives FDA Clearance for MRI System
Roche Receives FDA Clearance for Insulin Pump Therapy System