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ScreenPoint Medical receives FDA clearance for AI application Transpara to assist radiologists with reading screening mammograms
Press releases may be edited for formatting or style | December 03, 2018
Women's Health
CHICAGO (PRWEB) NOVEMBER 26, 2018 -- ScreenPoint Medical, a medical imaging company developing artificial intelligence (AI) solutions for the early detection of breast cancer, announced today that it has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for Transpara™ detection and decision support software, designed to assist radiologists with the reading of screening mammograms.
Transpara is the first AI application for detecting breast cancer in screening mammograms to gain 510(k) Clearance from the FDA, based on its unique functionality which interactively provides support for detection and diagnosis. The Clearance was supported by the results of a multi-reader, multi-case Reader Study, which demonstrated that radiologists significantly improved detection accuracy when using Transpara for decision support without increasing reading times. In the study, the stand-alone sensitivity and specificity of Transpara was nearly at the same level as that of radiologists. The full results of the study, “Detection of breast cancer using mammography: Impact of an Artificial Intelligence support system,” was recently published in Radiology.
In the editorial, “Will AI Succeed Where Traditional CAD Failed?”, published as a companion to the Reader Study, Dr Manisha Bahl wrote: “The results of the study by Rodríguez-Ruiz and colleagues suggest that integration of AI systems into routine clinical practice could help radiologists with varying levels of training and experience achieve performance benchmarks and therefore improve the quality of mammography across the country.”
“We are very proud to be the first AI company to receive FDA Clearance from the FDA for a system that not only helps finding suspicious abnormalities, but also helps radiologists decide whether they should be followed up,” said Prof. Nico Karssemeijer, PhD, CEO of ScreenPoint Medical. “This is a significant advance and we look forward to working with breast imagers in the U.S. to make AI work in clinical practice to improve early detection of breast cancer.”
Transpara already has European regulatory approval (CE Mark) for use with mammography and digital breast tomosynthesis (DBT) images from multiple vendors and is installed at leading breast imaging centers in Europe. Transpara™ DBT is still investigational in the U.S.
ScreenPoint will showcase Transpara and its integration with multiple vendor workstations at the upcoming 104th Annual Radiological Society of North America (RSNA) meeting, November 25-30, 2018 (South Hall #2976). Two studies demonstrating that radiologists significantly improved cancer detection in mammography when using Transpara while maintaining workflow will also be presented this week at RSNA:
