Profusa wins CE mark approval for real-time tissue oxygen monitoring platform

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Wireless Lumee Oxygen
Wireless Lumee Oxygen

Profusa has announced that 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 chronic changes in tissue oxygen levels. 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, according to a statement, is designed to monitor compromised tissue in conditions such as peripheral artery disease (PAD) and critical limb ischaemia (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 visualisation using the Lumee app.

In addition, the 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. Also, the wireless reader is easy to set up and incorporate into clinical procedures,” said Marianne Brodmann, 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 PAD and other serious conditions in which blood flow to the limbs is impeded,” said Ben Hwang, chairman and CEO of Profusa.

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