FDA Grants Breakthrough Designation to Paige.AI

Expedites Product Development and Provides Priority Regulatory Review
For Paige.AI’s Pioneering Clinical-Grade Artificial Intelligence in
Pathology

NEW YORK–(BUSINESS WIRE)–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.

Contacts

Media
Sard Verbinnen & Co.
Matt Benson/Cameron
Seligmann
212-687-8080

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