BioIntelliSense announced that it won FDA 510(k) clearance for its BioSticker on-body sensor for scalable remote care and initiated the U.S. commercial launch of the product last week.
The BioSticker is designed to allow for continuous monitoring of vital signs and actionable insights to provide opportunities for early detection of potentially avoidable complications from a home setting. The company’s medical-grade data-as-a-service platform contributes the data and analytics to the BioSticker to potentially create an accurate, cost-effective solution.
Denver-based BioIntelliSense has a strategic collaboration with UCHealth and its CARE Innovation Center to demonstrate the applications of the BioSticker services and develop new models of data-driven care that are patient-centered and built for scale, according to a news release.
“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,” BioIntelliSense CEO Dr. James Mault said in the release.
“The future of healthcare will see the lines blurred between the hospital, clinic and home,” added UCHealth chief innovation officer Dr. Richard Zane. “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.”