LEXINGTON, Mass.-(BUSINESS WIRE)-MC10 Inc., the company developing wearable systems for seamless healthcare data collection, announced today that their BioStamp nPoint™ system has received Food and Drug Administration 510(k) clearance.
BioStamp nPoint is a wireless, biometric data collection platform intended for use by healthcare professionals and researchers for the continuous collection of physiological data in the home or traditional healthcare settings.
The BioStamp nPoint system includes numerous improvements and enhancements to BioStampRC®, its successful predecessor.
“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.” commented Dr. Arthur Combs MD, Chief Medical Officer of MC10. The BioStamp nPoint in-home kit includes a smartphone running the MC10 Link App that guides patients through sensor application, protocol specific tasks, prescribed activities and ePRO assessments.
The BioStamp nPoint in-clinic kit includes a tablet running the MC10 Investigator App that allows for patient management and sensor command and control.
“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 at the University of Rochester, Rochester, NY. The BioStamp nPoint system is configured and packaged to meet both in-home and in-clinic needs and is available for sale or rental beginning June 2018.
MC10 is headquartered in Lexington, MA. Visit MC10 online at www.mc10inc.com.