BioSticker Receives FDA Clearance for Continuous Vital Signs Monitoring

The U.S. Food and Drug Administration (FDA) recently announced clearance for the BioSticker™, an on-body sensor that could revolutionize remote patient care. The BioSticker device offers a new standard in remote monitoring of patients with kidney failure and those transitioning to dialysis treatment at home.

The BioSticker device pairs medical-grade remote data capture with advanced analytics to produce accurate and trustworthy readings, aiding in early detection of potential complications.

This innovative device was created by BioIntelliSense, a company funded in part by Fresenius Medical Care North America (FMCNA), as part of its mission to support the development of products and technologies that could make a significant impact on the healthcare system. This new continuous health monitoring and clinical intelligence platform seeks to deliver highly efficient care at a fraction of the cost of traditional remote patient monitoring.

“This exciting medical grade sensor technology can help generate new clinical insights during the time between a treatment or a visit with a doctor, hopefully improving care delivery and reducing costs to the healthcare system,” said Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care. “Our collaboration with BioIntelliSense seeks to improve patient health and support new models of value based care for managing patients with kidney disease.”

The BioSticker is the first single-use device for 30 days of continuous vital signs monitoring to be cleared by the FDA, providing an efficient and in-depth connection between clinicians and patients while still at home. Its discreet design offers an effortless patient experience, worn comfortably on the upper left chest, and is auto-enabled to monitor the patient’s vital signs.

Tracking vital signs and physiological biosignals, the BioSticker device picks up resting heart and respiratory rates, skin temperature, and sleep, as well as more active trends like body position, steps and activity level, gait analysis, and fall detection. It can even identify more specific symptoms like coughing and sneezing.

"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 personalized clinical intelligence," said James Mault, MD, FACS, CEO of BioIntelliSense.

FMCNA will bring expertise in data analytics and artificial intelligence to the company’s investment in BioIntelliSense’s work, striving to improve the care that clinicians provide and patients receive. It is part of an ongoing effort by FMCNA to improve remote treatment monitoring, which studies show has reduced hospitalizations and technique failure, as well as develop new solutions such as telehealth for home patients.