Paige's FullFocus™ Digital Pathology Viewer Earns FDA Approval

FDA Clearance for Paige's Digital Pathology Solutions

Paige, an innovator in the field of AI technology, has achieved an important milestone with the FDA 510(k) clearance for its FullFocus™ digital pathology image viewer. This advanced tool is now recognized for use with both the Leica Aperio GT 450 DX scanner and the Hamamatsu NanoZoomer S360MD Slide scanner system, marking a significant step forward in the integration of AI in pathology.

Enhancing Clinical Workflows

James Butler, who serves as VP of Marketing at Hamamatsu, expressed enthusiasm about the implications this clearance has for clinical operations. "We are excited that Paige's FullFocus™ digital slide viewer is FDA cleared for clinical use. This development reflects the ongoing industry-wide commitment to providing seamless integration of cutting-edge solutions, accelerating the transition to digital pathology and enhancing clinical workflows," he stated.

Wide Compatibility and Regulatory Focus

The FullFocus™ platform does not only accommodate the specified scanners; it has previously received clearance for the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner as well. This broad compatibility positions FullFocus™ as one of the most adaptable digital pathology systems in the market today. Paige continues to prioritize high-quality, compliant solutions that keep pace with the evolving demands of the industry.

A Commitment to Innovation in Cancer Diagnostics

According to Razik Yousfi, CEO and CTO of Paige, the recent FDA clearance is testament to the company's dedication toward developing pioneering solutions that significantly impact cancer diagnostics. "Our ability to successfully navigate the rigorous regulatory landscape highlights our role as a leading innovator in combining AI with digital pathology technologies that advance the frontiers of healthcare," he affirmed.

Building the Future of Cancer Care

Paige is fostering the development of innovative digital pathology solutions designed to support precision medicine initiatives and refine clinical workflows. By merging advanced technology with the reliability expected of regulatory-grade products, Paige is paving the way for a new era in cancer care.

A Unique Approach to Data Utilization

With access to an expansive dataset that includes millions of digitized pathology slides, clinical reports, and genomic data, Paige is able to address multifaceted aspects of cancer research and treatment. This innovative approach ensures that Paige can develop highly accurate AI solutions aimed at revolutionizing cancer detection and diagnosis.

Leading the Way in AI-driven Pathology

Recognized as the first FDA-approved AI application in the field of pathology, Paige sets a benchmark for precision diagnostics. The company continues to push the limits of technology, having developed the first million-slide foundation model for cancer, thereby transforming revolutionary insights into practical, life-altering products.

Contact Information

For those looking to learn more about Paige and its groundbreaking work in AI and pathology, please visit www.paige.ai for further details.

Frequently Asked Questions

What FDA clearance did Paige receive recently?

Paige's FullFocus™ digital pathology image viewer obtained FDA 510(k) clearance for use with specific slide scanning systems.

Which systems is FullFocus™ compatible with?

FullFocus™ is compatible with the Leica Aperio GT 450 DX and the Hamamatsu NanoZoomer S360MD Slide scanner system.

Why is FDA clearance important for Paige?

This clearance validates Paige's technology, enabling its application in clinical settings and enhancing the credibility of its AI solutions in cancer diagnostics.

What sets Paige apart in the pathology space?

Paige utilizes unique datasets and advanced technology to develop AI solutions for cancer diagnostics, leading the industry in innovation.

How is Paige contributing to precision medicine?

By creating AI-driven tools that enhance diagnostic accuracy and clinical workflows, Paige is making significant strides in advancing precision medicine in cancer care.

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