Medical devices company Profusa has secured the Conformité Européenne (CE) Mark approval to market its Wireless Lumee Oxygen Platform.
Profusa’s new Lumee Oxygen Platform is intended for continuous, real-time monitoring of tissue oxygen in patients with acute or chronic changes in tissue oxygen levels.
The CE mark approval allows the company to commercialise its new oxygen monitoring device system for use in physician offices, hospitals, ambulatory care and sports medicine clinics in the European Union.
Wireless Lumee Oxygen Platform designed to monitor compromised tissue in patients
The company said that its new platform will monitor compromised tissue in patients with conditions including peripheral artery disease (PAD) and critical limb ischemia (CLI), which are caused due to narrowing of blood vessels and reduced blood flow to the lower limbs.
In addition, the device has been designed to contain a small biosensor, and an intelligent data platform, along with a low profile, lightweight wireless patch.
The patch attached to the skin will read the signal from the biosensor injected in the upper arm, shoulder or leg, and transmits the data to a tablet, which displays real-time data visualization through Lumee app.
The firm said that its Wireless Lumee Oxygen Platform offers a broader data picture that includes changes in oxygen, comparison of current patient’s data with historical data from a clinical registry study, and a data report, allowing physicians to monitor oxygen levels before, during and after an endovascular procedure.
Profusa chairman and CEO Ben Hwang said: “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. 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.”
