Proscia’s Concentriq Dx Attains CE Mark Under IVDR For Use In Primary Diagnosis
Regulatory milestone to accelerate company’s international growth amid expanding presence in Europe
PHILADELPHIA--(BUSINESS WIRE)--Proscia®, a leader in digital and computational pathology solutions, today announced that its Concentriq® Dx platform has been certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis. This certification will enable the company’s continued growth in the European diagnostic pathology market, where it is helping leading laboratories to modernize their routine operations.
The IVDR certification demonstrates that Concentriq Dx complies with the stronger quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.
“Proscia’s dedication to quality is unwavering,” said Kim Rendon, Director of Regulatory Affairs. “The IVDR certification is a testament to our focus on delivering the safe, efficacious solutions that pathologists need to provide faster, more accurate diagnoses and ultimately improve patient outcomes.”
A singular, secure platform, Concentriq Dx* helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks. As laboratories increasingly look to unlock new insights with computational solutions, Concentriq Dx is designed to support them in realizing pathology’s AI-enabled future.
Concentriq Dx is the platform of choice for top reference laboratories and health systems in Europe, including LabPON and Uppsala University Hospital. The European geography has seen some of the earliest adopters of digital pathology due to a widespread shortage of pathologists among other systemic challenges in the traditional laboratory model. Rising demand for diagnostic services continues to intensify pressure for digital transformation.
In response, Proscia has established subsidiary entities in Ireland and Spain to further drive its international growth. These entities will enable the company to increasingly scale its operations and continue to support its expanding customer base.
“Since we entered the European market in 2019, we have welcomed leading laboratories onto the Concentriq Dx platform and built a world-class team,” said David West, CEO. “We are now better positioned than ever before to accelerate this momentum as we see through our mission of perfecting cancer diagnosis.”
Proscia will be exhibiting at next week’s European Congress on Digital Pathology. To learn more about Concentriq Dx and see a demo, visit the company at booth #B09.
*Concentriq Dx is CE-marked under IVDR and is available for primary diagnosis in the US during the COVID-19 public health emergency.
Proscia is a software company that is accelerating pathology’s digital transformation to change the way we understand diseases like cancer. Its Concentriq digital pathology platform and powerful AI applications are advancing the 150-year-old standard of research and diagnosis towards a data-driven discipline, unlocking new insights that accelerate discovery, improve patient outcomes, and fulfill the promise of precision care. Leading diagnostic laboratories and 10 of the top 20 pharmaceutical companies rely on Proscia’s software each day. For more information, visit proscia.com.