FDA Grants Breakthrough Designation to Paige.AI
Congratulations to Paige.AI for obtaining Breakthrough Device designation. My recollection from a final guidance issued by the FDA late last year and taken from their own news release:
“The [Breakthrough Device] program was established by the 21st Century Cures Act to provide developers with “a more agile process” to get feedback from the FDA during the premarket clearance process, paving the way for “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition[s].”
Sponsors of devices obtaining breakthrough status will receive “interactive and timely communication” with assigned FDA staff who are experienced in “innovative approaches to regulatory science” as well as clear communication of the FDA’s expectations. Breakthrough devices, which includes those granted designation under the FDA’s Expediated Access Pathway, will also be placed at the top of the review queue; however, review times for these devices might still be longer than for other devices because of the “novel scientific issues these devices may raise,” the FDA wrote.”
NEW YORK, March 7, 2019 – Paige.AI, the leading start-up in computational pathology focused on building artificial intelligence (AI) that will transform the clinical diagnosis and treatment of cancer, today announced that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), the first such designation for AI in cancer diagnosis publicly announced by any company.
“Paige.AI is focused on providing artificial intelligence tools to pathologists that will enable them to become faster and more accurate in their diagnosis and treatment recommendations for the care of cancer patients,” said Dr. Leo Grady, Chief Executive Officer of Paige.AI. “We are thrilled to receive Breakthrough designation and look forward to collaborating with the FDA to bring our products to market, starting with prostate cancer and expanding from there.”
The FDA’s Breakthrough Device designation is granted for technologies that have the potential to provide for more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases, where timely availability is in the best interest of patients because no approved alternative exists or because the technology offers significant advantages over existing approved alternatives. The Breakthrough Device program was created by the 21st Century Cures Act.
“We are honored to have been granted Breakthrough designation by the FDA, which underscores the groundbreaking nature of our technology as the leading clinical-grade AI in computational pathology to combine vast amounts of high-quality data with unique deep learning architectures in service of delivering better patient care,” said Dr. Thomas Fuchs, Co-Founder of Paige.AI.
Paige.AI was launched in early 2018 based on technology developed by Fuchs and his colleagues and a license agreement with Memorial Sloan Kettering Cancer Center (MSK). MSK began digitizing its pathology slides four years ago. Under the license agreement, Paige.AI receives de-identified images of digitized slides – more than one million such slides to date — and is funding the digitization of an additional four million archive slides, which in total will create the largest digital pathology dataset. Paige.AI is working with this de-identified dataset to develop a comprehensive portfolio of AI products across cancer subtypes to serve the needs of pathologists around the world.
About Paige.AI
Based in New York, Paige.AI is bringing together the world’s leading experts in machine learning, computational pathology, and clinical practice who are committed to fundamentally improving the diagnosis and treatment of cancer. For more information, please visit: https://paige.ai.
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Source: Paige.AI
