Zebra Medical Vision Captures 1st FDA Clearance for Oncology with Mammography Solution

Deep-learning medical imaging analytics developer Zebra Medical Vision announced Monday it has secured its sixth 510(k) clearance from the U.S. Food & Drug Administration (FDA) – this time for its new mammography solution.

Dubbed HealthMammo, this tool is intended to help providers identify and prioritize suspicious mammograms, company officials said. By implementing this solution, they added, providers can process mammograms with suspect findings first instead of continuing to use the “first-in, first-out” standard of care.

The FDA clearance covers use of the algorithm with single reader paradigms to support triage and workflow improvement. The tool is already approved for double reader paradigms internationally.

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Intended for use with 2D mammograms, HealthMammo automatically categorizes an image as “suspicious” or “not suspicious” and sends it to Zebra Medical’s imaging analytics platform for processing and analysis for suspected breast lesions. Radiologists receive the results either through their worklist or other dedicated application.

According to Ohad Arazi, Zebra Medical Vision chief executive officer, HealthMammo identified two missed cases during initial testing that ultimately resulted in cancer diagnoses that would have been otherwise overlooked.

“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,” he said.

By supporting early detection efforts, HealthMammo can minimize COVID-19-induced care gaps, he said, by not only working through the growing number of mammograms, but by also more quickly identifying patients with abnormal findings.

One provider who has tested the technology agreed.

“As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased,” said Michael Fishman, M.D., breast imaging section chief at Boston Medical Center. “Zebra Medical Vision’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging.”

This clearance marks the first for a Zebra Medical Vision oncology solution that is part of the company’s AI1 (“All-In-One”) bundle. In addition, according to company data, Zebra Medical is the first start-up to secure FDA clearances for AI technologies in CT, X-ray, and mammography.