BioIntelliSense Announces FDA Clearance of the BioSticker™, the First Single-Use Medical Device Enabling 30 Days of Continuous Vital Signs Monitoring
An effortless patient experience combined with actionable clinical intelligence to bring medical-grade care to the home
BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its medical grade Data-as-a-Service (DaaS) platform and 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.
“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.
BioIntelliSense is built on the foundation of a sophisticated team of engineers and data scientists with decades of expertise in wearable sensor development. With these distinctive capabilities and proprietary technologies, the company is poised to help transform care delivery under the leadership of Dr. Mault, an industry veteran who has an accomplished business and clinical career that has culminated in a number of successful connected health ventures.
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. This alliance is committed to developing and validating new models of data-driven care that are patient-centered and built for scale.
“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.”
“We are proud and excited to be working with the innovative teams at UCHealth and the University of Colorado Anschutz Medical Campus,” Dr. Mault said. “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.”