Proscia Achieves Key Regulatory Milestone With Medical Device Single Audit Program (MDSAP) Certification

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Compliance with global regulatory standards accelerates continued expansion in global diagnostic pathology market

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Proscia®, a leading provider of AI-enabled digital pathology solutions, has received Medical Device Single Audit Program (MDSAP) certification, a rigorous validation of the company’s practices for delivering high quality medical device software. This certification accelerates the company’s expansion into the diagnostic pathology market to help laboratories worldwide keep pace with the rising cancer burden and improve patient outcomes.

MDSAP was established to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of five different markets: United States, Australia, Brazil, Canada, and Japan. In successfully completing the MDSAP audit, Proscia has demonstrated that its quality management system satisfies strict requirements related to the design, development, production, deployment, and sale of its solutions.

“At Proscia, our commitment to quality underlies all that we do,” said Natalia Remmel, Director of Quality and Regulatory Affairs. “The MDSAP certification reflects our focus on building safe and effective solutions to help laboratories scale their digital pathology implementations as they look to deliver faster, more accurate diagnoses.”

The current standard of care for diagnosing cancer relies on the pathologist’s interpretation of patterns in tissue as viewed under a microscope. Proscia is working to transform this 150-year-old manual and subjective practice to address the growing demand for diagnostic services, as pathologists have faced a 42% increase in diagnostic workload over the last decade, and improve patient outcomes. With its Concentriq® Dx digital pathology solution and suite of AI modules, the company is accelerating workflows while driving confidence and quality gains.

Concentriq Dx enables pathologists to securely read and share cases from any location while automating time-consuming, error-prone tasks. The software can be rapidly deployed on existing IT infrastructure and works with leading scanners and laboratory information systems (LIS), offering seamless integrations with Philips, Leica, 3DHISTECH, and Hamamatsu among other solutions.

CE-marked for use in primary diagnosis in Europe, Concentriq Dx is also available for remote use in clinical practice in the United States during the COVID-19 public health emergency. This comes in response to the FDA’s recent guidance aimed at expanding the availability of digital pathology devices.

“From driving meaningful improvements in accuracy and efficiency to enabling remote case review during the public health emergency, Concentriq Dx is helping laboratories to transform their pathology operations at a time when change is more critical than ever before,” said David West, CEO of Proscia. “With our relentless dedication to quality, we are accelerating our expansion into the global diagnostic pathology market to continue advancing the standard of care.”

About Proscia
Proscia is a software company that is changing the way the world practices pathology to transform cancer research and diagnosis. With the company’s Concentriq digital pathology platform and pipeline of AI-powered applications, laboratories are leveraging new kinds of data to accelerate discoveries and improve patient outcomes. Proscia’s team of technologists, scientists, and pathologists is bringing a fresh approach to an outdated industry, helping the world to keep pace with the increasing demand for pathology services and fulfill the promise of precision care. For more information, visit proscia.com.

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Ryan McKenna
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