Technology
The Proteus Digital Health™ Feedback System
Our digital health feedback system is powered by you. It includes wearable and ingestible sensors that work together to detect ingestions and physiologic data. By capturing objective information and providing actionable insights, you can take control, communicate with caregivers and clinicians, and stay well.
Our system received European regulatory approval (CE Mark) in August 2010. The patch received U.S. FDA market clearance as a medical device in April 2010. The ingestible sensor received U.S. FDA market clearance as a medical device for co-ingested applications in July 2012. For more information on the technology, please reference this publication.
Frequently Asked Questions
Question
Is the system safe?
Answer
Our system is CE marked, certifying that our products meet the EU health, safety, and environmental requirements, which ensure consumer safety. Our patch and ingestible sensor are also cleared for marketing by the U.S. FDA. Our technology has been used over thousands of days by participants in clinical trials with no serious problems (adverse events) reported.
Question
How big is the ingestible sensor? What is it made of?
Answer
The sensor resembles a grain of sand in size and make-up—measuring 1mm square and made mostly of silicon.
Question
Does the ingestible sensor contain a battery?
Answer
The sensor does not contain a battery; it is powered entirely by you. Our sensor contains two conductive materials, one on either side. When these get wet in your stomach, they power the sensor for a short amount of time. This works just like a potato battery.
Question
What happens to the ingestible sensor after it’s consumed?
Answer
The ingestion sensor is designed to move through the body in the normal process of digestion.
Question
How long is each patch worn?
Answer
Each patch can be worn for up to seven days.
Question
Is the patch battery operated?
Answer
Yes, the patch is battery-operated. The battery lasts approximately seven days.
Question
What does the ingestible sensor record?
Answer
The sensor communicates a unique identifying number that is detected by the patch. The patch stores this number along with the exact time of detection.
Question
What does the patch record?
Answer
Besides communicating with the ingestible sensor, the patch records heart rate, temperature, activity and rest patterns.
Question
Does the system interfere with medical devices – like pacemakers – and vice versa?
Answer
The system meets all standards required for safe use alongside other medical devices. However, we recommend removing the patch prior to Magnetic Resonance Imaging (MRI).
Question
What happens to my information? Is it private?
Answer
Yes, you are in control of the information collected by the system. You direct who sees the information and you can change or stop that access at any time.
Question
Is the digital health feedback system the same as the 'Raisin' system I've heard about previously?
Answer
Yes, we previously referred to our digital health feedback system as the Raisin System and no longer use that terminology. You may have also heard about an "IEM," which we now call an ingestible sensor, and a "Personal Monitor," which we now refer to as the wearable sensor, or patch.
Question
How much does it cost? Is it covered by my insurance?
Answer
The cost will depend on the context in which the system is being used.
Question
Does Proteus have competitors?
Answer
We have the only commercial-ready sensor that can directly confirm ingestion. In addition, our wearable sensors have the most capabilities at the lowest cost and smallest size. We deliver full solutions that integrate sensor hardware, software and content (your existing drugs co-ingested with today’s sensor), to generate and correlate a rich and unprecedented set of information streams.