Biometric ‘BioSticker’ Gets FDA Clearance

Continuous health monitoring and clinical intelligence company BioIntelliSense Inc. announced it has been granted FDA clearance for the commercial launch of its BioSticker on-body sensor.

A Data-as-a-Service (DaaS) product, BioSticker offers Remote Patient Care (RPM) through continuous monitoring of the wearer’s vital signs and provides actionable insights to clinicians.

“We are at the inception of a remarkable new era in healthcare that will employ medical grade sensor technologies to effortlessly capture remote patient data and generate personalized clinical intelligence,” said James Mault, MD, FACS, CEO of BioIntelliSense.

Data and analytics collected through the sensor are delivered to health practitioners for analysis, allowing for more cost-effective patient care.

In a partnership with UCHealth and its CARE Innovation Center, BioIntelliSense aims to demonstrate the value and clinical applications of the BioSticker device, and to develop and validate new models of data-driven, patient-centered care.

“The future of healthcare will see the lines blurred between the hospital, clinic and home,” said Dr. Richard Zane, UCHealth Chief Innovation Officer and Chair of Emergency Medicine at the University of Colorado School of Medicine. “The use of the BioSticker device for continuous health monitoring enables us to monitor a patient in their home and recognize when a patient may have an exacerbation of illness even before they manifest symptoms. This may reduce hospitalizations, emergency department visits and shorten hospital stays, creating cost efficiencies for health systems,” he added.

“We are proud and excited to be working with the innovative teams at UCHealth and the University of Colorado Anschutz Medical Campus,” said Dr. Mault. “It is a remarkable collaboration and clinical proving ground for our continuous monitoring and predictive data services platform. UCHealth has made it possible for BioIntelliSense to rapidly accelerate the development of our technology, as well as optimize its clinical validation.”

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January 29, 2020 – by Tony Bitzionis