mivenion GmbH, a pioneer in dedicated real-time fluorescence optical imaging systems, today announced the Xiralite® fluorescence imaging system X4 has received 510(k) clearance from the U.S. Food and Drug Administration for acquiring fluorescent images for the visual assessment of circulation as a method for the evaluation of tissue perfusion and related tissue microcirculation in hands.
Fluorescence optical imaging is a sensitive and safe imaging technology that has been proven in clinical medicine for years. In vivo fluorescence imaging has several important advantages over other imaging techniques. There is no exposure to harmful radiation, it is relatively inexpensive, and images can be acquired rapidly. The fluorescence camera system Xiralite® in combination with the diagnostic dye ICG is the first dedicated solution for visualization of microcirculation in the hands. The imaging procedure is optimized to detect even very low amounts of the microcirculation marker ICG. It thus enables early visualization of changes of the microcirculation in a multitude of different diseases, including inflammation and perfusion disorders. The patient exam can be performed at the point of care with real time results.
“With more than fifty systems in routine clinical use, mainly in Europe, Xiralite® has proven its value in the medical field”, says Dr. Malte Bahner, managing director of mivenion, the producer of the Xiralite® system. “It really impacts productivity in the routing setting to the benefit of patients and physicians alike. In addition, with more than three dozen original publications in peer reviewed journals, including the leading scientific journals in the field, the scientific community has validated the Xiralite® technology. We are proud that we now can also offer our innovative technology to customers in the US. After all, the US is the world”s most important market.”
“Advanced imaging modalities have revolutionized the practice of rheumatology. I am convinced that Xiralite® will effectively integrate into the diagnostic workflow at my center and deliver crucial additional information for our patients, as it has already been impressively demonstrated in Europe. The patient centric treatment is becoming increasingly complex in my field, offering treatment options not thought of only a few years ago. We strive to combine innovative new approaches for the management of diseases with our long-standing expertise for the benefit of our patients. Xiralite® will be another step forward in this direction” said Alvin F. Wells, MD, PhD founder and director of the Rheumatology & Immunotherapy Center in Franklin, WI
mivenion GmbH is a Berlin, Germany based life-science company focusing on personalized medicine for patients with inflammatory and autoimmune diseases and oncology. With its strong expertise in both pharmaceuticals and medical devices, mivenion is providing cutting edge solutions for life-long patient care. A compelling network of academia and industry partners is supporting mivenion in achieving its goals. A broad patent portfolio is the foundation of mivenion”s proprietary position. mivenion”s drug development candidates comprise both diagnostic and therapeutic properties and are perfectly suited for optimizing each individual treatment case. mivenion”s medical solutions encompass innovative medical imaging and provide evidence on treatment outcome. Xiralite®, the leading product of mivenion, enables the ICG-based fluorescence optical imaging examination of the hands.
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