So innovative was the offering being pioneered by Proteus Digital Health that the company had to craft a new regulatory pathway in partnership with the FDA. Four years later, commentators are describing its approval as a major milestone in digital medicine.
The sensor is integrated on to a pill or other ingested product. Once the ingestible sensor reaches the stomach, it is powered by contact with bodily fluids to communicate a unique signal through the patient's tissue to a patch on the skin. The patch, in turn, relays the data to a mobile phone application. Proteus Digital Health may not be known well, yet but amongst those who've invested in its product are Medtronic and Novartis. The latter company hopes to use the technology with a drug it has already received approval for to prevent post-transplant organ rejection.
Of course the device will not solve the entire compliance puzzle, rather it will allow doctors access to definitive information in the not insignificant patient population who claim to have taken medicine when they haven't really done so.
For further information, visit the company's website and look out for their animated video.
Photo courtesy of Proteus Digital Health