Tele: 561.316.3330

Breaking Medical Device Industry News

Saturday, October 23, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeDIGITAL PLATFORMSProfusa Receives CE Mark Approval to Market Wireless Lumee® Oxygen Platform
HomeDIGITAL PLATFORMSProfusa Receives CE Mark Approval to Market Wireless Lumee® Oxygen Platform

Profusa Receives CE Mark Approval to Market Wireless Lumee® Oxygen Platform

Profusa is a digital health company that is pioneering the next generation of personalized medicine. Today the company announced it has received Conformité Européenne (CE) Mark approval to market its Wireless Lumee® Oxygen Platform for continuous, real-time monitoring of tissue oxygen in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The company will initially market the new wearable, wireless system for use in physician offices, hospitals, ambulatory care and sports medicine clinics in the European Union.

The system is designed to monitor compromised tissue in conditions such as peripheral artery disease (PAD) and critical limb ischemia (CLI). Both conditions result from a narrowing of blood vessels and reduced blood flow to the lower limbs.

The Wireless Lumee Oxygen Platform consists of a tiny biosensor with an intelligent data platform. A low profile, lightweight wireless patch, which adheres to the skin, “reads” the fluorescent signal from the biosensor injected in the upper arm, shoulder or leg. The wearable patch then transmits the data wirelessly to a tablet, which displays real-time data visualization using the Lumee app.

In addition, the Wireless Lumee Oxygen Platform provides a broader data picture than the previous platform, which was a wired version. The data include changes in oxygen, comparison of current patient’s data with historical data from a clinical registry study, and a data report. The new outputs allow physicians to monitor a patient’s oxygen levels before, during and after an endovascular procedure, in which blocked arteries are cleared.

“The Wireless Lumee Oxygen system does a few important things. It measures information that is key for patient care, giving feedback via the tablet. And the wireless reader is easy to set up and incorporate into clinical procedures,” said Marianne Brodmann, M.D., a vascular specialist at the Medical University of Graz, Austria.

“The more comprehensive and detailed we can make our data, the better we are able to help people living with peripheral artery disease and other serious conditions in which blood flow to the limbs is impeded,” said Ben Hwang, Ph.D., chairman and CEO of Profusa. “We designed the Wireless Lumee Oxygen Platform to be small and wearable in order to increase its uptake and use. Our goal with both generations of the Lumee Oxygen Platform is to transform care for patients who could benefit from continuous, real-time monitoring of tissue oxygen levels. We believe that the Wireless Lumee Oxygen Platform will especially help realize the promise of remote patient monitoring and digital health applications.”

spot_img

DON'T MISS

United States Insulin Delivery Devices Market Report 2021

This new report provides an in-depth assessment of the U.S insulin delivery devices market dynamics, opportunities, future road-map, competitive landscape and discusses major trends.

Global $45 Billion Endoscopy Market Insights & Forecasts to 2025

The global endoscopy market is predicted to reach US$45.28 billion in 2025, growing, at a CAGR of 7.50%, for the duration spanning 2021-2025.

Global Remote Monitoring Devices Market Research Report (2021 to 2026)

Global Remote Monitoring Devices Market size was estimated at USD 1,035.35 million in 2020, is expected to reach USD 1,170.22 million in 2021.

Research Efforts Fuel the Future of Global Obstructive Lung Disease Management Markets – ResearchAndMarkets.com

The "Global Obstructive Lung Disease Management Research Report" report has been added.

Our Sister Publication: Biotechnology News Magazine

By using this website you agree to accept Medical Device News Magazine Privacy Policy