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.”
BioStamp nPoint has also been approved in a number of other ways.
The system comes with two companion apps, the patient-facing MC10 Link App and the researcher-facing MC10 Investigator app.
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.