Proteus Digital Health cleared a milestone this week when its ingestible sensor technology received de novo 510(k) clearance from US FDA. This 1-sq-mm device can be embedded in a pill that is taken with medication to record user compliance—when the drug was taken, at what dosage and so forth. The data is transmitted to a skin patch and can then be routed to a mobile phone app or other device. Paul Sonnier, who heads the Digital Health group on LinkedIn, applauded the development as one more example of how digital health is transforming healthcare as we know it.
Writes Sonnier: "As most of you have seen, Proteus Digital Health received de novo (i.e., no predicate or similar product on the market) FDA 510(k) clearance this week for their Ingestible Event Marker. In a happy coincidence, I had just congratulated company CEO Andrew Thompson on their name change from Proteus Biomedical to Proteus Digital Health. (More on that in a bit.)"
Sonnier believes that the Proteus platform is a trailblazing technology that will show the potential of digital health solutions for improving our health and the delivery of healthcare. The company's decision to incorporate digital health in its name also got his attention.
"It's all medicine, as Dr. Jay Sanders, the father of telemedicine, once told me," writes Sonnier. "But as we know, labels and tags serve many useful purposes, and in the case of the digital revolution converging with health and medicine, my preferred label— the one that neatly captures the trends we’re seeing—is Digital Health." That is also the name of Sonnier's LinkedIn group, which deserves your attention if you are at all interested in this convergence.
Incidentally, it's worth noting that the technology was approved for use in the European Union in 2010 and is expected to be brought to market in the United Kingdom later this year. Proteus Digital Health has partnered with the Lloydspharmacy chain to make the biosensor available under the name of Helius.