Volpara Health lands additional FDA clearance for breast cancer detection product

This marks the fourth clearance for Volpara’s breast health platform since its original authorization back in 2010.

Volpara Health, a maker of an artificial intelligence-enabled breast health platform, has added another FDA clearance to its core algorithm, the Volpara Imaging Software (VIS 3.2).

This marks the fourth clearance for Volpara’s breast health platform since its original authorization back in 2010, according to the company. The platform includes a suite of products that help with the early detection of breast cancer, mammography quality and workflow, breast density assessments, and creating personalized breast care plans.

The latest version of its algorithm has updates to improve the platform’s overall robustness by expanding its use to additional mammography machines, including those by Giotto and Siemens.

It also includes Volpara’s Open Virtual Appliance (OVA) architecture, which increases image processing security and allows the company to make software updates.


Ultimately, Volpara hopes its new clearance will expand its reach and help more patients treat breast cancer.

“These new innovations improve the overall security, scalability, robustness, and breadth of our breast health offering,” Dr. Ralph Highnam, group CEO of Volpara, said in a statement.

“Our objective with each enhancement is the pursuit of our mission – to eliminate advanced-stage breast cancer and save more families from cancer.”

This mission is important because about 13% of women will develop breast cancer at some point during their lifetime, according to the American Cancer Society. It says that early detection and prompt treatment are the best ways to successfully care for breast cancer, and recommends that women aged 45 to 54 get yearly mammograms.


Breast cancer screening tools that use AI, like Volpara’s, have been found to be useful in detecting cancer in mammograms. Specifically, these tools are helpful in double-reading screenings, which is considered the gold standard, because it can replace one of the two radiologists.

Earlier this year, Volpara acquired fellow breast cancer prevention company CRA Health for $18 million.

Other companies with FDA-cleared breast cancer screening tools include Whiterabbit and Zebra Medical Vision.

Google has also developed an AI mammogram tool, which, in a study, was able to reduce the numbers of false positives and false negatives in breast cancer detection.

Original Article: (https://www.mobihealthnews.com/news/volpara-health-lands-additional-fda-clearance-breast-cancer-detecting-product)