FDA clears BioIntelliSense on-body sensor
January 29, 2020
BioIntelliSense, a continuous health monitoring and clinical intelligence company, has announced the US commercial launch of its medical grade data-as-a-service platform and FDA 510(k) clearance of the BioSticker on-body sensor for scalable remote care.
The California-based company says it offers a new standard for remote patient monitoring 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 personalised clinical intelligence," said James Mault, CEO of BioIntelliSense.
The BioSticker is an 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 opportunities for early detection of potentially avoidable complications. Through the platform's data sets and analytics, efficient care is possible at a fraction of the cost of traditional remote patient monitoring.
BioIntelliSense is built on the foundation of a 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 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 UC Health 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 models of data-driven care that are patient-centred and built for scale.
"The future of healthcare will see the lines blurred between the hospital, clinic and home," said Richard Zane, UC Health 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 recognise when a patient may have an exacerbation of illness even before they manifest symptoms. This may reduce hospitalisations, emergency department visits and shorten hospital stays, creating cost efficiencies for health systems."
Mault added: "We are proud and excited to be working with the innovative teams at UC Health 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. UC Health has made it possible for BioIntelliSense to rapidly accelerate the development of our technology, as well as optimise its clinical validation."