Zebra Medical Vision announced that it received FDA 510(k) clearance for its HealthMammo mammography algorithm technology.
Shefayim, Israel-based Zebra Medical Vision develops the system, which already has CE Mark approval, to allow breast radiologists to prioritize and identify suspicious mammograms, providing a safety net for radiologists and offering faster reads on mammograms than the current standard of care, according to a news release.
The AI-based tool indicates “suspicious” or “not suspicious” classifications for every 2D mammography performed before sending them to Zebra Medical’s imaging analytics platform, where they are processed and analyzed.
“Our work is twofold: supporting the medical team’s overload and ensuring the well-being of patients, by supporting early detection and reducing the anxiety surrounding uncertainty,” Zebra Medical Vision CEO Ohad Arazi said in the release. “The fact that during initial testings we were able to identify two cases that were missed, and to have these women be recalled and diagnosed with cancer, shows the vast impact and potential contribution of AI in oncology.
“With this fully commercial and regulated product, we aim to provide even more value and help patients and providers navigate the new COVID effected reality we are all facing. We’re proud of the achievements we’ve made in the past few months, providing U.S. healthcare with a growing portfolio of automatic solutions to enhance patient care, especially during these times.”
The HealthMammo system is Zebra’s first oncology solution to win FDA clearance, as the company already had approval for AI-based technology in the CT and X-ray imaging modalities.