FDA clears Zebra Medical's breast cancer AI for spotting suspicious mammography lesions

Zebra Medical Vision, developer of artificial-intelligence-based software for scanning X-ray images and automatically spotting critical health issues, has received its first FDA clearance in cancer screening.

The company’s AI is designed to identify mammograms suspected of breast cancer. The program is the company’s sixth FDA green light, following digital solutions using CT scans and X-rays to detect brain bleeds, pneumothorax, spinal fractures and more.

Zebra Medical’s HealthMammo offering, which previously received a CE mark, aims to scan a radiologist’s entire workflow and flag the 2D mammograms with higher cancer risk for priority review. By moving the few scans with suspicious lesions to the front of the line, the company hopes to shorten the time a patient waits for their diagnosis.

“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,” said CEO Ohad Arazi.

“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,” Arazi added. 

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According to the FDA, about 40 million mammograms are performed in the U.S. during a typical year. However, the COVID-19 pandemic has caused many clinical visits to be postponed—with a 94% drop in imaging volume seen during lockdown periods. Now, oncologists are facing a growing backlog of scans to process, according to the former Fierce 15 winner.

“With this fully commercial and regulated product, we aim to provide even more value and help patients and providers navigate the new COVID-affected reality we are all facing,” Arazi said. “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.”

Zebra Medical will bundle its mammography AI alongside its other programs as part of an “all-in-one” offering with a fixed annual fee and a price of up to $1 per scan.