Denver Startup Receives FDA Clearance for its BioSticker On-Body Sensor for Remote Patient Monitoring

BioIntelliSense, a company making sticker-like sensors that can monitor patient vitals, received FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care. BioIntelliSense offers a new standard for Remote Patient Monitoring (RPM) by combining an effortless patient experience with medical grade clinical accuracy and cost-effective data services. The company also announced the launch of its medical grade Data-as-a-Service (DaaS) platform.

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“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.

The BioSticker is an advanced on-body sensor that allows for effortless continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting, thereby creating unique opportunities for early detection of potentially avoidable complications. Through the platform’s data sets and analytics, highly-efficient care is now possible at a fraction of the cost of traditional remote patient monitoring, said BioIntelliSense in a press release.

BioIntelliSense BioSticker FDA clearance
Image: BioIntelliSense

BioIntelliSense has established a strategic collaboration with UCHealth and its CARE Innovation Center to demonstrate the value and clinical applications of the BioSticker device and medical-grade services.

“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.”

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Commenting on the partnership with UCHealth, Dr. Mault said:

“We are proud and excited to be working with the innovative teams at UCHealth and the University of Colorado Anschutz Medical Campus. 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.”