MC10 Receives its First FDA Approval for the BioStamp nPoint System

BioStamp nPoint

When David Icke, former CEO of MC10 Inc., spoke at our WT | Wearable Technologies Conference 2012 USA in San Francisco, we already knew that the BioStamp nPoint system is going to something big. The Cambridge, Massachusetts-based sensor maker has now received its first FDA 510(k) clearance for the BioStamp nPoint system. The system is a more advanced version of the company’s BioStampRC which didn’t get FDA clearance.

“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,” says Don Fuchs, MC10s’ senior vice president of marketing and strategy. “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.”

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BioStamp nPoint, a wireless system intended for use by researchers and healthcare professionals, is a biometric data collection platform. It can continuously collect physiological data at home or healthcare settings. It is designed for research studies and clinical trials where scientists need to collect relevant data.

BioStamp nPoint

Fuchs said that their customers, who are mainly pharmaceutical companies, have told them they are struggling not so much with the concept of digital endpoints, but how to collect that data without bringing patients or participants into the clinic.

“How can I do that in the home setting, collecting longitudinal information over a long period of time?” he said.

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The system comes with two companion apps, the MC10 Link App facing patients and the MC10 Investigator app facing researchers.

The BioStamp nPoint in-home kit includes a smartphone running the MC10 Link App. MC10 Link app provides the patient with instructions on how to apply the patches and also deliver alerts and reminders to take medication.

The researcher uses the MC10 investigator app, where he is provided with information about all the data from the sensors. The system can monitor not only direct data, but derived data such as heart rate, posture and a number of other functions related to sleep.

“We need objective, sensitive measures of health that can be assessed by anyone, anytime, anywhere. MC10’s new sensor brings us one step closer to a reality that can improve health and accelerate the development of new therapies,” noted Dr. Ray Dorsey, MD, MBA and the Director of the Center for Health & Technology (CHET) at the University of Rochester, Rochester, NY.

BioStamp nPoint will be available in the market by enterprise organizations in June. Fuchs said that MC10 already has partnerships lined up with pharmaceutical companies. He expects those trials to be up and running by the third quarter of 2018.