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

High Acceptance of Advanced Healthcare Equipment Promoting Growth of a-Si X-ray Flat Panel Detectors | Fact.MR’s Medtech Analysis

Big data and analytics will drive patient outcomes in a big way, and the coming years will witness a growing emphasis on healthcare service providers in the business of gathering and processing patient health data.

KA Imaging Makes Distribution Deal with Malaysia Based BeyMed

BeyMed is an emerging medical solutions company with a great potential,” said Amol Karnick, President and CEO of KA Imaging.

BASMA.com Raises a $3M Series a Round to Scale Up Its Health Tech Platform in the MENA

The UK-based, MENA focused, startup BASMA.com closed $3M in its Series A round of funding led by MEVP with the participation of SOSF, IM capital and returning investors iSME, Cedar Mundi Ventures and IFA capital.

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

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles