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Home » BioIntellisense wins FDA nod for BioButton multi-patient wearable monitor

BioIntellisense wins FDA nod for BioButton multi-patient wearable monitor

October 2, 2024 By Sean Whooley

BioIntelliSense BioButton BioDashboard (1)
The BioButton wearable and BioDashboard system. [Image courtesy of BioIntelliSense]
BioIntelliSense announced today that it received FDA clearance for its rechargeable BioButton multi-patient wearable and BioDashboard system.

The BioButton device expands the company’s portfolio of continuous patient monitoring solutions with a rechargeable, reusable inpatient solution. It automates vital sign collection across medical surgical units, specialty care areas and emergency departments. The company says it delivers hospital-level care in the home.

Denver-based BioIntelliSense’s BioDashboard clinical intelligence system enables scalable, automated trending notifications. It personalizes the notifications for each patient, helping one clinician monitor hundreds of BioButton users simultaneously. BioDashboard’s configurable dashboard view enables proactive clinical decision-making as well.

BioIntelliSense says its offerings help improve patient safety and clinical workflow efficiencies. They reduce the burden of repetitive manual tasks associated with spot check vital sign measurements and documentation. The cloud-based platform offerings extend from in-hospital to the home and feature robust third-party and EMR system integration, with data exchange capabilities.

This marks the latest advancement for BioIntelliSense’s patient monitoring solutions, following a partnership with iRhythm last month. The company has previously inked collaborations with medtech giants Medtronic and Philips as well.

“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 Dr. James Mault, 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.”

Filed Under: 510(k), Big Data, Diagnostics, Digital Health, Electronic Medical Records (EMR), Food & Drug Administration (FDA), Health Information Technology, Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: BioIntelliSense, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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