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Wearable to Power Remote Care and Clinical Trials
The FDA-cleared BioSticker can provide continuous vital sign monitoring for up to 30 days. Image courtesy of BioIntelliSense Inc.

Wearable to Power Remote Care and Clinical Trials

BioSticker from BioIntelliSense can monitor patient vital signs and biosignals and transmit data to the cloud.

Within a few weeks of announcing FDA clearance and the launch of BioSticker, a single-use wearable for monitoring patient health, BioIntelliSense Inc. reports the sensor will be employed in two different remote patient monitoring programs.

The FDA-cleared BioSticker medical device is designed 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, Jim Mault, CEO of BioIntelliSense, told MD+DI. “BioSticker device allows for the continuous remote monitoring of a patient’s vital signs—respiratory rate at rest, heart rate at rest, and skin temperature—along with other parameters like activity levels, body position, and gait analysis. The simple ‘stick it on and forget it’ patient experience allows for remote data capture and reporting to enable personalized clinical intelligence.” Mault said that clinical applications span pre-surgical baseline assessments, condition management screening, and active remote patient monitoring (RPM) of complex care patients.

The physician-prescribed BioSticker is being used as part of a strategic collaboration with UCHealth and its CARE Innovation Center to clinically validate and to develop a continuous care model that extends beyond the walls of the hospital, Mault said.

Dr. Richard Zane, UCHealth Chief Innovation Officer and Chair of Emergency Medicine at the University of Colorado School of Medicine, explained more in a statement. "The future of healthcare will see the lines blurred between the hospital, clinic and home," he stated. "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." (Please see Zane explain the project in a video on the web page).

In addition, ClinOne, a provider of clinical trial management technologies, will be utilizing BioSticker to monitor patient health and provide clinical intelligence as part of the ClinOne ClinTrialConnect patient portal platform. The collaboration is expected to “deliver a wide array of vital signs and physiological biosignals to drive efficiencies and cost-effectiveness in implementing virtual clinical trials,” said Mault.

For the ClinOne project, BioSticker will capture patients’ vital signs and wirelessly and securely transmit such data to the BioIntelliSense BioCloud and ClinOne ClinTrialConnect platform for high-resolution patient trending and reporting. “With BioIntelliSense, we will be able to capture a wide array of medical-grade biosensor data and offer our enterprise clients a new standard for Remote Patient Monitoring (RPM), resulting in more efficient and scalable virtual clinical trials,” said Rob Bohacs, ClinOne CEO, in a statement.

Multiple clinical use cases and applications could be possible for the BioSticker device and BioIntelliSense data services. “As an example, the BioSticker device can be worn by a hip/knee replacement patient to provide a baseline pre-operative assessment for the orthopedic surgeon and anesthesiologist,” Mault told MD+DI. “In addition, the BioSticker device can enable active remote monitoring of a patient during their post-surgical recovery and rehabilitation phase to unlock unique clinical insights to guide treatment plans and facilitate better health outcomes.”

At-risk patient populations with complex care conditions could also be monitored and managed. “The ability to continuously monitor these patients may allow for earlier transition from the hospital to the comfort of the home setting,” Mault said.

Jim Mault, CEO of BioIntelliSense

Mault believes that the BioSticker device along with data services could potentially change the current healthcare paradigm as “the first-of-its-kind single-use device for continuous health monitoring of patients in their home,” he said. “The ability to analyze data sets has the promise of generating personalized clinical intelligence for the early detection of adverse trending or conditions. There is tremendous clinical value in being able to recognize when a patient may have an exacerbation of illness and to proactively intervene even before they manifest symptoms. The BioIntelliSense Data-as-a-Service (DaaS) and BioSticker medical device is offering a new standard for Remote Patient Monitoring (RPM) that is enabling an effortless patient experience with medical grade clinical accuracy at a fraction of the cost.”

BioIntelliSense announced the U.S. commercial launch of its data-as-a-service platform and FDA 510(k) clearance of the BioSticker in January 2020.

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