Volpara Receives FDA Clearance for Breast Density Algorithm

Volpara Health announced Friday it has received 510(k) clearance from the U.S. Food & Drug Administration for the latest version of Volpara Imaging Software.

This version – VIS 3.2 – incorporates learnings from artificial intelligence to augment the robustness of the breast density assessment algorithm. In addition, this clearance approves VIS 3.2 for use on other mammography machines, including those from Giotto and Siemens.

The new version offers improved imaging processing security through the Open Virtual Appliance architecture, and it also makes it easier for Volpara to monitor, services, and update software, company officials said.

“These new innovations improve the overall security, scalability, robustness, and breadth of our breast health offering,” said Ralph Highnam, Ph.D., Volpara’s Group chief executive officer. “Our objective with each enhancement is the pursuit of our mission – to eliminate advanced-stage breast cancer and save more families from cancer.”

With this approval, Volpara marks its fifth clearance since launching Volpara Imaging Software in 2010. It is a key science algorithm that supports the Volpara Breast Health Platform, a product suite designed to improve early breast cancer detection through augmented mammography quality and workflow, volumetric breast density assessment, and personalized breast care.

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