News | Digital Pathology | March 08, 2019

FDA Grants Breakthrough Designation to Paige.AI

Designation expedites product development and provides priority regulatory review for clinical-grade artificial intelligence in pathology

FDA Grants Breakthrough Designation to Paige.AI

March 8, 2019 — Artificial intelligence (AI) startup company Paige.AI has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its AI designed to enhance the clinical diagnosis and treatment of cancer. It is the first such designation for AI in cancer diagnosis publicly announced by any company, according to Paige.AI.

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. For these technologies, 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.

Paige.AI was launched in early 2018 based on technology developed by company co-founder Thomas Fuchs, Ph.D., 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 1 million such slides to date — and is funding the digitization of an additional 4 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.

For more information: www.paige.ai

Related Content

Warm Springs Health & Wellness Center Implements Digisonics Solution for OB Ultrasound
News | Ultrasound Women's Health | June 17, 2019
Warm Springs Health & Wellness Center in Warm Springs, Ore., has selected the Digisonics OB PACS (picture archiving...
International Working Group Releases New Multiple Myeloma Imaging Guidelines

X-ray images such as the one on the left fail to indicate many cases of advanced bone destruction caused by multiple myeloma, says the author of new guidelines on imaging for patients with myeloma and related disorders. Image courtesy of Roswell Park Comprehensive Cancer Center.

News | Computed Tomography (CT) | June 17, 2019
An International Myeloma Working Group (IMWG) has developed the first set of new recommendations in 10 years for...
Konica Minolta Healthcare Introduces New Financing Services Program for Exa Enterprise Imaging
News | Enterprise Imaging | June 17, 2019
June 17, 2019 – Konica Minolta Healthcare Americas Inc.
Sectra Providing Centralized Regional Solution for Digital Pathology in the U.K.
News | Digital Pathology | June 14, 2019
Sectra has signed a five-year contract with North Tees and Hartlepool National Health System (NHS) Foundation Trust for...
M*Modal and Community Health Network Partner on AI-powered Clinical Documentation
News | PACS Accessories | June 13, 2019
M*Modal announced that the company and Community Health Network (CHNw) are collaborating to transform the patient-...
iCAD Introduces ProFound AI for 2D Mammography in Europe
News | Artificial Intelligence | June 13, 2019
iCAD Inc. announced the launch of ProFound AI for 2D Mammography in Europe. This software is the latest addition to...
A static image drawn from a stack of brain MR images may illustrate the results of a study. But a GIF (or MP4 movie), created by the Cinebot plug-in, can scroll through that stack, providing teaching moments for residents and fellows at Georgetown University

A static image drawn from a stack of brain MR images may illustrate the results of a study. But a GIF (or MP4 movie), created by the Cinebot plug-in, can scroll through that stack, providing teaching moments for residents and fellows at Georgetown University. Image courtesy of MedStar Georgetown University Hospital

Feature | Information Technology | June 13, 2019 | By Greg Freiherr
Editor’s note: This article is the third in a content series by Greg Freiherr covering the Society for Imaging In
Studycast PACS Adds Two-factor Authentication to Improve Data Privacy and Security
News | Cybersecurity | June 12, 2019
Core Sound Imaging announced the addition of two-factor authentication (2FA) to the security measures available for the...
The Current Direction of Healthcare Reform Explained by CMS Administrator Seema Verma
News | Radiology Business | June 11, 2019
June 11, 2019 — Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma addressed the American Med
Aidoc Earns FDA Approval for AI for C-spine Fractures
Technology | Artificial Intelligence | June 11, 2019
Radiology artificial intelligence (AI) provider Aidoc announced the U.S. Food and Drug Administration (FDA) has cleared...