Proteus Digital Health has received an update to its FDA 510(k) clearance for its digital medicine platform, adding a new indication to the clearance. The system is now, to the company’s knowledge, the first technology to have an indication in its FDA clearance for measuring medication adherence.
“We are delighted that our collaborative work with the FDA continues to enable positive progress,” Proteus cofounder and Chief Medical Officer Dr. George Savage said in a statement. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”
A Proteus spokesperson told MobiHealthNews that neither the product nor its functionality have changed; the update merely officially clears Proteus to claim and market its product's ability to quantify medication adherence, and demonstrates the FDA's commitment to supporting a new category of medication adherence tracking technologies. The new clearance will help Proteus to sell clinical partners on the device and opens the door for other technologies to measure adherence in an FDA-cleared way.
The Proteus digital medicine platform is a medication management and adherence system that includes unique measurement tools, like sensor-enabled pills, a peel-and-stick biometric sensor patch worn on the body, and companion smartphone apps. The patch records when a pill is ingested and also tracks other things like sleep patterns and physical activity levels. The ingestible sensor component secured FDA clearance in July 2012, at first as a de novo medical device, while the company’s sensor-laden patch got FDA clearance in 2010.
The "intended use" section of the 2012 clearance describes Proteus's platform as “a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory” and says that the patch “may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.”
According to Proteus, the company has worked closely and collaboratively with the FDA to secure this new clearance.
"We’re pleased that the FDA took the time, effort and consideration to do this for the first time, to make it a priority and look at adherence as a problem that’s not just the patients’ problem," a spokesperson told MobiHealthNews.