Technology | Computer-Aided Detection Software | November 28, 2018

ScreenPoint Medical Receives FDA Clearance for Transpara Mammography AI Solution

Artificial intelligence application assists radiologists with reading screening mammograms, provides decision support

ScreenPoint Medical Receives FDA Clearance for Transpara Mammography AI Solution

November 28, 2018 — ScreenPoint Medical announced 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 FDA 510(k)-cleared artificial intelligence (AI) application for detecting breast cancer in screening mammograms, based on its functionality that 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,” were recently published in Radiology.1

In the editorial, “Will AI Succeed Where Traditional CAD Failed?”, published as a companion to the reader study, Manisha Bahl, M.D., 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.”

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 104th Annual Radiological Society of North America (RSNA) meeting, Nov. 25-30, 2018 in Chicago. Two studies demonstrating that radiologists significantly improved cancer detection in mammography when using Transpara while maintaining workflow will also be presented at RSNA:

  • “Detecting Breast Cancer in Mammography: A Deep Learning-Based Computer System versus 101 Radiologists”; and
  • “Improving Radiologists' Breast Cancer Detection with Mammography Using a Deep Learning-Based Computer System for Decision Support.”
     

Utilizing state-of-the-art image analysis and 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.

For more information: www.screenpoint-medical.com

Reference

1. Rodriguez-Ruiz A., Krupinski E., Mordang J.J., et al. Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System. Radiology, Nov. 20, 2018. https://doi.org/10.1148/radiol.2018181371

Related Content

Philips Launches Zenition Mobile C-arm Platform
Technology | Mobile C-Arms | February 18, 2019
Philips announced the launch of Philips Zenition, its new mobile C-arm imaging platform. Mobile C-arms are X-ray...
Amazon Comprehend Medical Brings Medical Language Processing to Healthcare
News | Artificial Intelligence | February 15, 2019
Amazon recently announced Amazon Comprehend Medical, a new HIPAA-eligible machine learning service that allows...
Fujifilm Exhibits Enterprise Imaging Solutions and Artificial Intelligence Initiative at HIMSS 2019
News | Enterprise Imaging | February 15, 2019
Fujifilm Medical Systems U.S.A. Inc. and Fujifilm SonoSite Inc. showcased their enterprise imaging and informatics...
IBM Watson Health Announces New AI Collaborations With Leading Medical Centers
News | Artificial Intelligence | February 14, 2019
IBM Watson Health announced plans to make a 10-year, $50 million investment in research collaborations with two...
Medivis Launches SurgicalAR Augmented Reality Platform
Technology | Advanced Visualization | February 14, 2019
Medical imaging and visualization company Medivis officially unveiled SurgicalAR, its augmented reality (AR) technology...
Densitas Enters Partnership Agreement With TeleMammography Specialists
News | Breast Density | February 14, 2019
Breast imaging analytics company Densitas Inc. announced a new collaboration partnership with TeleMammography...
Office of the National Coordinator Releases Proposed Rule on Healthcare Data Interoperability
News | Information Technology | February 14, 2019
The U.S. Department of Health and Human Services (HHS) has proposed a new rule to support seamless and secure access,...
Sponsored Content | Webinar | Artificial Intelligence | February 14, 2019
This Nuance-sponsored ITN webinar will be held at 1 p.m. Eastern time, Tuesday, Feb. 26, 2019.
Siemens Healthineers Demonstrates Artificial Intelligence, Healthcare Digitalization at HIMSS19
News | Artificial Intelligence | February 13, 2019
February 13, 2019 — At the 2019 Healthcare Information and Management Systems Society (HIMSS) global conference and e
PaxeraHealth Launching Universal Image Sharing Platform at ECR 2019
News | PACS Accessories | February 13, 2019
PaxeraHealth will launch the PaxeraShare image sharing platform at the 2019 European Congress of Radiology (ECR) annual...