FDA approval of on-body sensor may benefit patients with ESKD on home dialysis
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BioIntelliSense has received FDA approval to market BioSticker, an on-body sensor that allows for continuous monitoring of vital signs of patients in home settings, including dialysis care.
“We believe this device provides an opportunity to transform how we monitor patients on dialysis at home,” Frank Maddux, MD, global chief medical officer for Fresenius Medical Care, told Healio Nephrology. “Our collaboration also seeks to improve patient health and support new models of value-based care for managing patients with kidney disease. This exciting new sensor technology can help generate insights during the time between a treatment or a visit with a doctor, hopefully improving care delivery and reducing costs to the health care system.”
Fresenius announced in July 2019 that it would invest funds in BioIntelliSense, saying it will use its experience with analytics and artificial intelligence to advance the platform and assist BioIntelliSense in the development of clinical pathways that could avoid hospitalizations.
“We are committed to helping more people living with chronic kidney disease through earlier interventions and are proud to invest in a company that is leading innovation in remote health sensors and services that we believe will help us accelerate change, further improve quality care and slow progression of chronic kidney disease,” Bill Valle, CEO of Fresenius Medical Care North America, said at the time.
The BioSticker is a single-use design that captures medical grade data for up to 30 days. The company reports it is worn on the upper left chest and captures respiratory rate, heart rate at rest, skin temperature, body position, activity levels and sleep status. It also offers high-resolution gait analysis and fall detection.
BioIntelliSense has established a collaboration with University of Colorado Health and its CARE Innovation Center to demonstrate the value and clinical applications of the BioSticker device and medical-grade services.
“The future of health care will see the lines blurred between the hospital, clinic and home,” Richard Zane, MD, chief innovation officer at University of Colorado Health and chair of emergency medicine at the University of Colorado School of Medicine, said in a press release. “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.” – by Mark E. Neumann
References:
https://biointellisense.com/assets/biosticker-fda-clearance.pdf
Disclosure: Maddux reports no relevant disclosures.
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https://biointellisense.com/assets/biosticker-fda-clearance.pdf
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