Biointellisense has received FDA approval for its bio-sticker31. January 2020
Biointellisense has received FDA approval for its bio-sticker
New York, 31.1.2020
Biointellisense Inc. received approval from the US FDA for the Biosticker body sensor with a scalable remote power supply.
This device enables continuous monitoring of vital signs and can therefore play an important role in the early detection of potentially preventable complications. The sticker is worn on the upper left chest and can now monitor breathing rate, heart rate at rest and skin temperature. It can also respond to symptomatic events.
James Mault, CEO of Denver-based Biointellisense, which has already set a trend with Apple Watch and Fitbit. “But the reality is that these wrist wearables are specifically designed for fitness and exercise. They are not medical grade, clinically validated devices regulated by the FDA”.
Biointellisense has also established a strategic collaboration with UCHealth, a major Colorado-based non-profit healthcare system, and its Care Innovation Center to demonstrate the value and clinical application of the bio-sticker device and medical-grade services. The goal of this alliance is to develop and validate new models of data-driven care that are patient-centered and scale.
“The future of healthcare will blur the boundaries between the hospital, clinic and home,” said Richard Zane, Chief Innovation Officer of UCHealth and Chair of Emergency Medicine at the University of Colorado School of Medicine, “Using the biosticker device for continuous health monitoring will allow us to monitor a patient at home and detect when a patient has a worsening condition before symptoms appear.
Last summer, Fresenius Medical Care North America invested in Biointellisense. The investment was part of Biointellisense’s Series A financing and was handled by the business segment Fresenius Medical Care Ventures.