Artificial Intelligence: FDA Grants Breakthrough Device Designation To Israeli Startup Ibex’s AI-Powered Galen Platform For Cancer Detection
The Galen platform helps pathologists detect and grade cancer in biopsies.
In a situation where there is a growing and alarming scarcity of trained pathologists, and a rising number of tissue biopsies to be scanned for cancer, Ibex Medical Analytics has deployed AI to address the gap. It announced Wednesday that it won Breakthrough Device Designation from the U.S. FDA for its Galen cancer detection platform. (NoCamels)
AI-powered cancer diagnostic solutions
The Galen Prostate and the Galen Breast are the first AI-powered cancer diagnostic solutions being used in pathological labs worldwide.
These applications, which run on the Galen platform, comprise the Ibex First Read and Ibex Second Read, which analyze biopsy cases even before a pathologist. The readings allow for case prioritization and are a useful cross-check when conducted in parallel with trained pathologists to identify any errors or discrepancies.
“Oncology treatments have made great strides, but to save more lives it is also essential to see technological advances in cancer diagnostics,” said David Shulkin, MD, former Secretary at the US Department of Veterans Affairs and an 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.”
“We are honored to have been granted the Breakthrough Device Designation,” said Ibex CEO and co-founder Joseph Mossel. “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.”
Shortage of pathologists
According to an article in Israel21c, there is a looming shortage of pathologists. “In the UK, 97 percent of labs report they are already understaffed. By 2030, the US will have 40% fewer pathologists than today,” says Mossel.
In the United States, the average age of pathologists is already 55, indicating that medical students at opting for different specializations.
As a result, there is increasing pressure on pathological personnel, and an increased risk of misdiagnosis and errors.
The company’s AI solutions are therefore timely. It trained its algorithms on 60,000 biopsy slides each of prostate and breast cancers to ensure accuracy.
Ibex launched in 2017.
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