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ScreenPoint Medical Receives FDA Clearance for AI Application Transpara™ to Assist Radiologists with Reading Screening Mammograms

ScreenPoint Medical Receives FDA Clearance for AI Application Transpara™ to Assist Radiologists with Reading Screening Mammograms Transpara is the First AI Application to be Cleared by the FDA for Providing Decision Support to Radiologists Reading Screening Mammograms

PR Newswire

CHICAGO, Nov. 26, 2018

CHICAGO, Nov. 26, 2018 /PRNewswire-PRWeb/ -- 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:

  •     "Detecting Breast Cancer in Mammography: A Deep Learning-Based Computer System versus 101 Radiologists (RC215-13, Monday, November 26, 11:10-11:20 AM); this will be presented in the Arie Crown Theater, as part of the Breast Series: Hot Topics.
  •     "Improving Radiologists' Breast Cancer Detection with Mammography Using a Deep Learning-Based Computer System for Decision Support," (SSK02-03, Wednesday, November 28, 10:50-11AM).

Utilizing state of the art image analysis and revolutionary deep learning technology, Transpara automatically identifies soft-tissue and calcification lesions and combines the findings of all available views into a single cancer suspiciousness score. Breast imaging professionals can use this Transpara Score to automatically identify exams that are highly likely to be normal and the exams with features indicating highly increased risk of cancer. Interactive decision support is provided to improve assessment of lesions. Information is provided concurrent during reading and only when needed. As a result, it does not slow down reading.

"This is just the beginning - we will continue to bring increasingly powerful algorithms to the market," said Karssemeijer. "ScreenPoint works with a growing number of partners on integration of Transpara in existing breast imaging workstations to rapidly bring the application to real clinical practice."

About ScreenPoint Medical BV
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 Nico Karssemeijer and Michael Brady, two experts in breast imaging, machine learning, computer vision, and computer-aided detection. The main office is in Nijmegen, The Netherlands.

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Media Contact:
Chris K. Joseph


SOURCE ScreenPoint Medical

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Last Updated: 26-Nov-2018