Google Health, radiology vendor seek regulatory approval of AI as independent mammography reader

Google Health is working with radiology vendor iCAD to seek approval for the use of artificial intelligence as an independent breast image reader, the two announced Monday.

Under terms of the agreement, iCAD will integrate Google’s AI technology into its ProFound Breast Health Suite for 2D Mammography over the next 20 years. Once the product is approved, providers will be able to use the mammography tool “as an independent reader for breast cancer screening” across the globe, the companies said.  

“The conventional double-reading workflow utilized by most countries, where mammograms are assessed by two separate radiologists, has become increasingly challenging due to the scarcity of radiologists worldwide,” iCAD president and CEO Dana Brown said in an Aug. 14 announcement. “As the global radiologist shortage continues to impact patient care, healthcare organizations are seeking clinically proven solutions to help their radiology departments run more efficiently and adeptly handle the workload in front of them.”

The firms first partnered in November 2022, when Google licensed breast cancer AI technology to iCAD. This led to the recently amended “development and commercialization agreement.” Google’s mammography AI system outperformed six human readers, scoring an area under the receiver operating characteristic curve greater than the average radiologist by an absolute margin of 11.5%, a 2020 analysis found. Another trial estimated it could reduce a second reader’s workload by 88%.

“Through this collaboration we hope to not only alleviate the increasing burdens on radiologists worldwide but also reduce disparities in healthcare across the globe,” Greg Corrado, PhD, head of health AI at Google, said in the announcement.

Nashua, New Hampshire-based iCAD also announced its second quarter earnings results Monday, including an adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) loss of $1.5 million. In a separate announcement, Brown said the plan is to concentrate on countries “where a double-reading workflow is standard practice.”

“With the majority of imaging facilities outside the U.S. still using 2D mammography as the standard of care, this agreement expands and accelerates our ability to serve this market and revolutionize screening for millions of women around the world,” she added.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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