The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, which will help fast track the clinical review and regulatory approval of its platform.
Granting such approval is given to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases.
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.
According to the National Cancer Institute, approximately 39.5 percent of men and women will be diagnosed with cancer at some point during their lifetimes (based on 2015–2017 data).
“In 2020, an estimated 16,850 children and adolescents ages 0 to 19 will be diagnosed with cancer and 1,730 will die of the disease,” the institute noted.
An estimated 1,806,590 new cases of cancer will be diagnosed in the United States in 2020, it noted, and 606,520 people will die from the disease.
“Oncology treatments have made great strides, but to save more lives it is also essential to see technological advances in cancer diagnostics. Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care,” David Shulkin, MD, advisor to Ibex Medical Analytics said.
AI cancer diagnosis platform role
“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,” David added.
That said, pathologists play an important 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.
As such, 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.
Joseph Mossel, chief executive officer and co-founder of Ibex Medical Analytics, said: “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. 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.”