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Ibex Granted FDA Breakthrough Device Designation

Ibex’s Galen™ AI-powered platform is recognized by the FDA as breakthrough technology with the potential to more effectively diagnose cancer

Ibex Medical Analytics, the pioneer in AI-powered cancer diagnostics, announced the granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of its platform.

The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. 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.

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Pathologists play a crucial role in the detection and diagnosis of disease, with their assessment being vital for correct treatment decisions in cancer care. However, a rise in cancer prevalence and advances in personalized medicine have resulted in growing diagnostic complexity that significantly increases pathologists’ workloads. 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. It has already demonstrated outstanding outcomes in clinical studies and is deployed in labs worldwide where it is used as part of everyday clinical practice. 

“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 David Shulkin, MD, former Secretary, U.S. 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.”

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“We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world class tools for pathologists to ensure every patient receives a timely and correct diagnosis, while supporting pathology labs and health systems to increase efficiency and accuracy,” said Joseph Mossel, Chief Executive Officer and Co-Founder of Ibex Medical Analytics. “Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continuing to collaborate with the agency as we accelerate our clinical program in the United States.” 

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