Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system. BioStamp nPoint is a more advanced version of the company's non-FDA cleared BioStampRC.
"BiostampRC was primarily developed as an investigational tool, primarily used by academia, as well as by pharmaceutical companies, but they were doing internal development work," Don Fuchs, MC10s' senior vice president of marketing and strategy, told MobiHealthNews. "Generally speaking, for new drug applications and for phase 1 through 4 FDA filings, the biometric sensors that would be used to collect data for those filings, the pharma companies are looking for FDA-cleared products because they need to be able to point to a clinical validation."
But BioStamp nPoint has also been approved in a number of other ways. The system consists of reusable adhesive sensor patches that can monitor users for 24 hours at a time. The sensors record vital signs like movement and heart rate and display them on an Android phone also provided by MC10. The system is designed to be used at home or in the clinic.
"Our customers, primarily pharmaceutical companies, have told us that where they’re struggling isn’t so much with the concept of digital endpoints — everyone’s rallying around that — it’s how do I collect that information, aside from bringing subjects into the clinic?" Fuchs said. "How can I do that in the home setting, collecting longitudinal information over a long period of time?"
The system comes with two companion apps, the patient-facing MC10 Link App and the researcher-facing MC10 Investigator app. The Link app instructs patients on how to apply the patches, and can also be used to deliver alerts and reminders to trial patients to take medication, and even to deliver patient reported outcome surveys directly through the app. The Investigator app displays the data from the sensors.
The system can monitor not only direct data, but derived data including heart rate variation, posture classification, and a number of specific metrics related to sleep.
BioStamp nPoint will be available for purchase by enterprise organizations in June. MC10 already has partnerships lined up with pharmaceutical companies, Fuchs said, and expects those trials to be up and running by the third quarter of 2018.