Israeli med-tech startup earns FDA approval for AI breast cancer solution – The Jerusalem Post

Israeli med-tech startup earns FDA approval for AI breast cancer solution – The Jerusalem Post

Israeli medical imaging technology start-up Zebra Medical Vision announced on Monday that it received US Food and Drug Administration (FDA) approval for its mammography solution HealthMammo.HealthMammo, which already earned the CE marking prior, is the company’s sixth solution to earn itself FDA approval – six solutions spread across three modalities (CT, x-ray and mammography), the first AI start-up to do so. The FDA approval for HealthMammo marks the company’s first oncology solution to earn the coveted “go-ahead” from the US-based federal agency.The HealthMammo solution itself prioritizes and identifies “suspicious” mammograms for radiologists to focus their attention on instead of using the standard “first-in first-out” method to diagnose a patient, which in turn recognizes problematic readings ahead of time while alerting the radiologist to the issue – allowing for early detection and intervention following a positive breast cancer 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 of Zebra Medical Vision Ohad Arazi. “The fact that during initial testings we were able to identify 2 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
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