BioIntelliSense secures FDA approval for BioSticker on-body sensor

29 January 2020 (Last Updated January 29th, 2020 12:03)

BioIntelliSense has received 510(k) approval from the US Food and Drug Administration (FDA) for its BioSticker on-body sensor for scalable remote care.

BioIntelliSense secures FDA approval for BioSticker on-body sensor
The BioSticker on-body sensor for scalable remote care. Credit: BioIntelliSense.

BioIntelliSense has received 510(k) approval from the US Food and Drug Administration (FDA) for its BioSticker on-body sensor for scalable remote care.

BioSticker is an on-body sensor that enables constant monitoring of critical signs and actionable insights of patients.

The platform assists doctors to access data from patients in the home setting, leading to early detection of potentially avoidable complications.

BioIntelliSense has also commercially launched its medical-grade Data-as-a-Service (DaaS) platform in the US.

DaaS platform captures vital signs every minute, as well as physiological biometrics and symptomatic events, providing an effortless experience for patients.

With the help of the platform’s advanced analytics, doctors can generate high-resolution patient trending and reporting to provide medical-grade care at homes.

BioIntelliSense CEO Dr James Mault said: “We are at the inception of a remarkable new era in healthcare that will employ medical-grade sensor technologies to effortlessly capture remote patient data and generate personalised clinical intelligence.”

BioIntelliSense has entered into a strategic partnership with UCHealth and its CARE Innovation Center to show the clinical applications of the BioSticker device and medical-grade services.

The partnership aims to build and validate models of data-driven care, patient-centred and designed for scale.

UCHealth chief innovation officer Dr Richard Zane said: “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 hospitalisations, emergency department visits and shorten hospital stays, creating cost efficiencies for health systems.”

Last July, Fresenius Medical Care North America invested in BioIntelliSense, which is working on a medical-grade data services platform for continuous, remote patient monitoring.