FDA gives clearance to UE LifeSciences breast cancer screening device

UE LifeSciences Inc. (UELS), a medical device manufacturer focused on providing novel breast cancer screening solutions, announced today that it has received market clearance from the U.S. Food and Drug Administration (FDA) for its NoTouch BreastScan™ device. NoTouch BreastScan™ is a contactless breast-imaging tool cleared by the FDA specifically for adjunctive diagnostic screening for the detection of breast cancer.

NoTouch BreastScan™ is the first fully computerized functional infrared imaging system that incorporates patent pending dual-infrared detector design. Unlike most breast thermography solutions, NoTouch BreastScan™ does not require manual interpretation of thermal data; instead, it dynamically analyzes temperature pixels from various infrared frames to create a real-time objective report for the doctor.

“We are pleased with FDA’s decision to finally bring NoTouch to the US market,” Matthew Campisi, VP Technology commented. “This computerized technology truly complements conventional tools, albeit without the pain and radiation aspects,” he added.

“NoTouch BreastScan™ does not discriminate dense breast tissue, which is good news for tens of millions of women in America,” said Azad Anand, MD, Radiologist and Director, Long Island Diagnostic Imaging in New York. John Gomes, MD, a leading gynecologist in New York says, “It looks at breast cancer from a physiologic vantage point not visible to anatomic imaging modalities like mammography and ultrasound. So when we combine the information from both sides, we can assess the full picture.”

UE LifeSciences Inc. plans to offer NoTouch BreastScan™ services to Gynecology, Medical Oncology and Radiology clinics in the U.S. starting from New York, New Jersey and Pennsylvania regions.