FDA OKs BioButton Multi-Patient Wearable and BioDashboard System

BioIntelliSense has earned U.S. Food and Drug Administration (FDA) clearance for its rechargeable BioButton multi-patient wearable and BioDashboard system to grow and scale hospital virtual care programs.
 
BioButton offers a rechargeable, reusable inpatient solution to automate vital sign collection across medical surgical units, specialty care areas, emergency departments. It can help deliver hospital level care at home, the company said.
 
The BioDashboard clinical intelligence system’s data-driven exception management allows scalable, automated trending notifications personalized to each patient. One clinician can monitor hundreds of BioButton patients simultaneously in a configurable dashboard view. The company hopes to create a transformational shift from episodic to high-frequency, continuous vital sign trend monitoring with BioButton and BioDashboard.
 
The BioButton and BioDashboard system is a cloud-based platform that extends from in-hospital to the home. It’s an interoperable tool with third-party and EMR system integration, as well as data exchange capabilities. The company affirmed that it adheres to strict privacy and security standards.
 
“We are advancing a new standard of care by automating the capture of thousands of multiparameter measurements each day and for every general care patient throughout their inpatient stay and now the BioButton Multi-Patient wearable is conveniently rechargeable with its own dedicated in-facility charging station,” said James Mault, MD, founder and CEO of BioIntelliSense. “The introduction of the rechargeable and reusable BioButton Multi-Patient wearable, combined with the BioDashboard clinical intelligence solution, provides health systems nationwide unprecedented economies of scale in making continuous care more affordable and accessible for every patient that is admitted to the hospital.”
 
Last month, the company signed an exclusive license agreement with iRhythm Technologies to develop and commercialize certain patented technology assets within ambulatory cardiac monitoring.