Denver's BioIntelliSense, a health monitoring and clinical intelligence company, announced this week that it received FDA clearance for its BioSticker, an on-body sensor for remote care.
The BioSticker is a sensor that allows for continuous monitoring of vital signs and collects actionable insights, delivered to clinicians from patients in the home setting.
The device is designed to be worn on the upper left chest for up to 30 days of continuous vital sign monitoring. It tracks respiratory rate, heart rate at rest and skin temperature, in addition to body position, activity levels and sleep status, among other things.
By remotely delivering these insights, the device gives clinicians additional opportunities for early detection of potentially avoidable complications.
"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," James Mault, MD, FACS, CEO of BioIntelliSense, said in a statement.
In addition to the FDA clearance, BioIntelliSense announced the U.S. commercial launch of its medical grade data-as-a-service platform. With the platform's advanced analytics, the company says clinicians will have access to high-resolution patient trending and reporting to enable medical grade care in the home.
BioIntelliSense has also established a strategic collaboration with UCHealth and its CARE Innovation Center to demonstrate the value and clinical applications of the BioSticker.
"We are proud and excited to be working with the innovative teams at UCHealth and the University of Colorado Anschutz Medical Campus," Mault said in the statement. "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."
