BioIntelliSense has secured FDA clearance for its BioButton Multi-Patient wearable and BioDashboard system, marking a significant advancement in continuous patient monitoring. This clearance allows for the deployment of a rechargeable, reusable device aimed at automating vital sign collection in hospitals and extending hospital-level care into the home.
The BioButton is designed to streamline the monitoring process across medical-surgical units, specialty care areas, and emergency departments. By automating the collection of vital signs, the device reduces the burden of manual spot-checks and documentation, freeing up clinicians to focus on more critical tasks. The system facilitates the capture of thousands of multiparameter measurements each day for each patient.
The BioDashboard clinical intelligence system complements the BioButton by providing scalable, automated notifications that are personalized for each patient. This enables a single clinician to monitor hundreds of patients simultaneously, making proactive clinical decisions based on a configurable dashboard view. The BioDashboard offers data-driven exception management, aiding clinicians in detecting significant changes in patient physiology for earlier intervention and better outcomes.
Dr. James Mault, founder and CEO of BioIntelliSense, stated, "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." He added that the introduction of the rechargeable BioButton, combined with the BioDashboard, provides health systems with unprecedented economies of scale, making continuous care more affordable and accessible.
The BioButton and BioDashboard system represent a shift from episodic to continuous vital sign trend monitoring. This comprehensive inpatient monitoring solution includes BioButton wearables, charging stations, BioHub Wi-Fi gateways, BioCloud data analytics, and the BioDashboard clinical intelligence system. The cloud-based platform extends from in-hospital to home care, offering robust third-party and EMR system integration with data exchange capabilities.
BioIntelliSense's technology aims to improve patient safety and clinical workflow efficiencies. The reduction in manual tasks allows for better prioritization of care and resource allocation to patients requiring more hands-on attention. This FDA clearance marks a significant step forward in making continuous care a more accessible and affordable reality for patients nationwide.