FDA clears Zebra Medical’s AI tool for mammograms

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 tes…

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Zebra Medical Vision wins FDA clearance for AI to predict osteoporosis

Zebra Medical Vision announced today that it received its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product.

The Kibbutz Shefayim, Israel-based company’s latest artificial intelligence-based product automatically identifies findings suggestive of compression fractures, which enables clinicians to place patients that are at risk of osteoporosis in treatment pathways that can prevent potentially life-changing fractures.

VCF expands Zebra’s AI1 bundle of FDA-cleared AI products, which now has a fourth U.S. patent in its bone health series, according to a news release. Zebra touts itself as the first AI startup in medical imaging to receive FDA clearance for a population health solution.

“Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are under detected globally,” Zebra CEO Ohad Arazi said in the news release. “Th…

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