Israel's Ibex Medical Analytics, an artificial intelligence (AI)-powered cancer diagnostics startup, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of its platform, the company announced this week.
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The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of the Galen platform's utility and potential benefit as well as the robustness of Ibex's clinical program.
Ibex's Galen platform uses Strong AI algorithms to help pathologists improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time and boost productivity.
"Oncology treatments have made great strides, but in order to save more lives it is also essential to see technological advances in cancer diagnostics," said Dr. David Shulkin, former Secretary of the US Department of Veterans Affairs and advisor to Ibex Medical Analytics.
"Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care. Ibex's AI platform has demonstrated success in helping pathologists worldwide improve care for patients with cancer. This FDA designation is an important step forward in making this technology broadly available in the United States," Shulkin said.
