Wearable sensor developer MC10 said yesterday it won FDA 510(k) clearance for its BioStamp nPoint wireless biometric data collection platform.
The newly cleared system is designed for the continuous collection of physiological data in either home or traditional healthcare settings, the Lexington, Mass.-based company said. The system succeeds the company’s previous BioStampRC sensor.
MC10 said that the BioStamp nPoint system features improvements over its predecessor, including being rechargeable, reusable and the ability to to collect data for 24 hours. The system can be used to measure, record and display general activity, postural classifications, vital signs and sleep metrics, MC10 claims.
“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,” Dr. Ray Dorsey of the University of Rochester said in a prepared statement.
The BioStamp nPoint sensors are connectible through smartphones and include an app to guide patients through sensor application and other prescribed activities. MC10 plans to launch the system in June.
“The nature, location, and endpoints of clinical trials for new drug development are all evolving rapidly. The BioStamp nPoint system was designed and clinically validated to meet this rapidly growing and expanding unmet need. BioStamp nPoint produces clinical quality, medical grade physiological data from research subjects in their own homes, available to investigators from virtually anywhere,” chief medical officer Dr. Arthur Combs said in a press release.
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