BioIntelliSense Gains FDA Clearance for BioButton and BioDashboard System

The U.S. Food and Drug Administration (FDA) has cleared BioIntelliSense Inc.’s rechargeable BioButton Multi-Patient wearable and BioDashboard system for hospital virtual care programs.

The BioButton Multi-Patient medical device expands BioIntelliSense’s portfolio of continuous patient monitoring solutions by offering a rechargeable and reusable inpatient solution for automating vital sign collection across medical surgical units, specialty care areas, emergency departments, and in delivering hospital level care at home.
 
The BioDashboard clinical intelligence system’s data-driven exception management enables scalable, automated trending notifications that are personalized for each patient. This facilitates the ability for one clinician to monitor hundreds of BioButton patients simultaneously in a configurable dashboard view for proactive clinical decisions. The transformational shift from episodic to high-frequency continuous vital sign trend monitoring with the FDA-cleared BioButton Multi-Patient wearable and BioDashboard system empowers clinicians to detect clinically meaningful changes in physiologic trends that create opportunities for earlier intervention and improved patient outcomes.
 
“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,” BioIntelliSense Founder/CEO James Mault, M.D., said. “The introduction of the rechargeable and reusable BioButton MultiPatient 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.”
 
The comprehensive BioIntelliSense inpatient monitoring solution—powered by the new BioButton Multi-Patient wearables and charging stations, BioHub Wi-Fi gateways, BioCloud data analytics, and the BioDashboard clinical intelligence system—provides a scalable continuous care model for improved patient safety and clinical workflow efficiencies by reducing the burden of repetitive manual tasks associated with spot check vital sign measurements and documentation. This staff time savings results in better prioritization of care and re-allocation of resources to those patients who need more hands-on care. Workforce efficiency is further enhanced with the BioDashboard’s exception management approach to continuous patient monitoring with low notification rates (<1 per patient per day) and high clinician engagement (99.71%) through actionable clinical insights that increase response time, reduce alert fatigue, and improve overall patient care.
 
The BioIntelliSense BioButton and BioDashboard System is a sophisticated cloud-based platform that extends from in-hospital to home and is an interoperable solution with robust third party and EMR system integration and data exchange capabilities. BioIntelliSense adheres to strict privacy and security standards and operates with an ecosystem approach that provides our customers the flexibility and scalability that is required to grow their continuous virtual care programs.
 
BioIntelliSense is developing solutions for health monitoring and clinical intelligence for virtual care and remote patient monitoring (RPM) from in-hospital to home. Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multiparameter vital signs and physiological biometrics through an effortless user experience.