FDA-Approved BioSticker to Power Remote Patient Monitoring for Virtual Clinical Trials

Feb 29, 2020 | Digital Health, Remote Patient Monitoring, Virtual Clinical Trials

FDA-Approved BioSticker to Power Remote Patient Monitoring for Virtual Clinical Trials

The upside for remote monitoring devices for clinical trials seems endless. The most recent U.S. Food and Drug Administration (FDA) approved device, BioSticker, a single-use wearable for monitoring patient health, will now be used in two different remote patient monitoring programs. 

TrialSite News reports on the explosion of patient monitoring devices that support ongoing clinical trials. The move toward decentralized, patient-centric trials continue with the advent of powerful cloud technology, Big Data systems, advancements in artificial intelligence (AI), compelling smartphone apps, and a dynamic and competitive ecosystem of entrepreneurs across multiple continents.

What is the BioSticker?

Approved by the FDA in January 2020, the BioSticker is an on-body sensor that enables constant monitoring of critical signs and actionable insights of patients. The platform assists doctors as well to access the data from the patient. See video with discussion from CEO of the sponsor company BioIntellisense.

What did the FDA clear the BioSticker for?

The FDA BioSticker medical device is to be worn comfortably on the upper left chest for effortless continuous vital sign monitoring for up to 30 days on a single-use device. Much like a band-aid, the patient can “stick it on and forget it”. This simple and convenient device can monitor vital signs such as the respiratory rate at rest, heart rate at rest, and skin temperature, as well as other parameters such as activity levels, body position, and gait analysis. This device enables remote data capture and reporting to enable personalized clinical intelligence.

What are the potential clinical applications?

CEO James Mault suggests that clinical applications will span pre-surgical baseline assessments, condition management screening, and active remote patient monitoring (RPM) of complex care patients.

UC Health and the CARE Innovation Center utilizes the BioSticker

The BioSticker is being used as part of a strategic collaboration with Colorado’s UCHealth and its CARE Innovation Center to clinically validate and develop a continuous care model that extends beyond the walls of the hospital. Dr. Richard Zane, Chief Innovation Officer and Chair of Emergency Medicine at the University of Colorado School of Medicine, noted: “The future of healthcare will see the lines blurred between the hospital, clinic, and home.” Dr. Zane continued, “The use of the BioSticker device for continuous health monitoring enables us to monitor a patient in their home and recognize when a patient may have an exacerbation of illness even before they manifest symptoms. This may reduce hospitalizations, emergency department visits, and shorten hospital stays, creating cost efficiencies for health systems.”

Tech Vendor “ClinOne Use Case

ClinOne will utilize the BioSticker to monitor patient health and offer clinical intelligence as part of the ClinOne ClinTrialConnect patient portal platform. This collaboration is positioned to “deliver a wide array of vital signs and physiological biosignals to drive efficiencies and cost-effectiveness in implementing virtual clinical trials.

In this deal, ClinOne will use the BioSticker to capture patients’ vital signs and wirelessly and securely transmit the data to the BioIntelliSense BioCloud and ClinOne ClinicalTrialConnect platform for high-resolution, patient trending, and reporting.

What is BioIntellisense Background?

Founded in 2018, BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures minute-to-minute vital signs, physiological biometrics, and significant events through the effortless patient experience. The FDA-cleared BioSticker™ device makes remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians will now have access to high-resolution patient trending and reporting to enable medical-grade care in the home.

The firm has about 20 employees and last year secured a strategic investment from renal-focused health giant, Fresenius Medical Care.


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