Tech News Summary:
- Proscia’s Concentriq AP-Dx has received 510(k) clearance from the FDA for primary diagnostic purposes in digital pathology.
- The software solution was proven to be non-inferior to traditional glass slide readings through a multi-site clinical study, leading to a milestone in improving cancer diagnostics.
- The company has also obtained CE-IVDR certification and product licenses in Canada and the United Kingdom, marking a significant advancement in digital pathology solutions.
Proscia, a leading provider of digital pathology software, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Concentriq AP-Dx software. This milestone marks a significant advancement in the field of digital pathology and opens the door for widespread adoption of Proscia’s innovative technology.
Concentriq AP-Dx is a cloud-based platform that leverages artificial intelligence and machine learning to assist pathologists in the diagnosis of diseases such as cancer. The software is designed to streamline the pathology workflow, improve diagnostic accuracy, and enhance collaboration among healthcare providers.
With FDA clearance, Proscia’s Concentriq AP-Dx is now authorized for clinical use in the United States, empowering pathologists to make more informed and efficient diagnoses. The software’s capabilities include automated slide review, image analysis, and data integration, all of which contribute to faster and more accurate pathology results.
“We are thrilled to receive FDA clearance for Concentriq AP-Dx, as it represents a significant milestone in the advancement of digital pathology,” said David West, CEO of Proscia. “This clearance validates the safety and efficacy of our software and paves the way for widespread adoption in clinical settings.”
The digital pathology market has experienced rapid growth in recent years, driven by the increasing demand for more efficient and accurate diagnostic tools. Proscia’s Concentriq AP-Dx is well-positioned to meet this demand, offering a modern solution for pathology labs seeking to improve patient care and outcomes.
As the healthcare industry continues to embrace digital transformation, Proscia’s FDA clearance for Concentriq AP-Dx is a testament to the company’s commitment to advancing the field of pathology through innovative technology. With this milestone, Proscia is poised to play a significant role in shaping the future of diagnostic healthcare.