24 July 2019 | News
Transpara gained European regulatory approval (CE) for use with multi-vendor mammography (2018) and digital breast tomosynthesis (DBT) images (2019)
Volpara Solutions and ScreenPoint Medical BV has announced signature of an agreement under which Volpara will sell ScreenPoint's Transpara™ products to breast imaging clinics in the United States, Australia, New Zealand, and parts of Asia.
Transpara is designed to assist radiologists with the reading of mammograms and is one of the first next-generation artificial intelligence (AI) applications for detecting breast cancer in screening mammograms to gain 510(k) clearance from the US Food & Drug Administration (FDA).
FDA clearance was supported by the results of a multi-reader, multi-case reader study published in February 2019 by Rodríguez-Ruiz, et. al, in Radiology, which demonstrated that radiologists using Transpara significantly improved detection accuracy without increasing reading times. Radiologists' performance consistently improved independent of their level of experience. In the groundbreaking JNCI publication that followed in March, it was reported that when compared to 101 radiologists, the stand-alone performance (sensitivity and specificity) of Transpara was as accurate. This suggests that the system gives an objective second opinion similar to that of a second radiologist.
Transpara gained European regulatory approval (CE) for use with multi-vendor mammography (2018) and digital breast tomosynthesis (DBT) images (2019) and is already installed at leading breast imaging centers in Europe.
Mark Koeniguer, Volpara Chief Commercial Officer, said: "We see Transpara as a perfect complement to our industry-leading Volpara®Enterprise™ and Volpara®Live!™ image-quality-management products. More can be seen in images by Transpara when images are of good quality."
"Based on the published research to date, we strongly believe that Transpara will deliver both improved mammographic cancer detection and enhanced workflow," said Dr. Ralph Highnam, Volpara CEO. "We are delighted to have ScreenPoint join our common cause and bring this powerful software to our customers."
Prof. Nico Karssemeijer, PhD, ScreenPoint Medical CEO, said: "I am excited that ScreenPoint and Volpara will now partner to bring Transpara to the United States and other markets, as Volpara is well established in the breast space globally. Together, the two companies will help breast care teams detect cancer earlier, streamline mammography reading, and personalize screening for women."
ScreenPoint Medical develops image-analysis technology for automated reading of mammograms and digital breast tomosynthesis exams, exploiting big data, deep learning, and the latest developments in artificial intelligence. ScreenPoint Medical was founded in 2014 by Profs. Nico Karssemeijer and Sir Mike Brady, experts in breast imaging, machine learning, computer vision, and computer-aided detection. The main office is in Nijmegen, the Netherlands.