Israeli AI startup claims it’s the first to receive FDA clearance across 3 imaging modalities

Israeli technology startup Zebra Medical Vision claims it is the first such company to receive U.S. FDA clearance for an artificial intelligence solution across three different modalities.

The latest comes for its HealthMammo algorithm, which helps radiologists pinpoint and prioritize suspicious breast images. Zebra said Monday that the software, already cleared in Europe, can act as a “safety net” for busy physicians playing catchup during the pandemic.

“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 CEO Ohad Arazi said in a statement issued July 27.

The Shefayim, Israel-based company said this is its first solution in oncology and sixth overall clearance. Previous approvals also included solutions in computed tomography and x-ray imaging, according to the announcement.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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