Proscia has obtained FDA clearance for its Concentriq AP-Dx, a digital pathology solution that enhances confidence and efficiency in primary diagnosis. The software offers pathologists an intuitive experience for viewing and interpreting whole slide images, facilitating collaboration and improving access to expertise.
Proscia Receives FDA Clearance for Concentriq AP-Dx: A Digital Pathology Solution for Primary Diagnosis
( Credit to: Med-technews )
Proscia, a leading provider of digital and computational pathology solutions, has recently received clearance from the United States Food and Drug Administration (FDA) for its Concentriq AP-Dx. This digital pathology solution has been approved for primary diagnosis purposes.
The Concentriq AP-Dx is a diagnostic software solution developed by Proscia. It offers pathologists an intuitive experience for viewing, interpreting, and managing whole slide images, ultimately enhancing confidence and efficiency. Additionally, the software facilitates collaboration and improves access to expertise. It is suitable for use in clinical settings of all sizes, ranging from individual reference laboratories to large hospital systems.
Clinical Study Demonstrates Accuracy of Concentriq AP-Dx
To support its 510(k) clearance application, Proscia conducted a multi-site clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners. The study aimed to demonstrate that diagnoses made using the Concentriq AP-Dx software are comparable to those made using traditional glass slide reads. The results showed that the difference in major discordance rates between digitally read slides and microscope-read slides was -0.1%, which is one of the strongest findings among similar publicly available studies.
David West, CEO of Proscia, Emphasizes Commitment to Cancer Diagnosis
David West, CEO of Proscia, expressed his satisfaction with this regulatory milestone, emphasizing the company's commitment to perfecting cancer diagnosis. He acknowledged the increasing pressure faced by pathologists in tackling major healthcare challenges and highlighted the role of Proscia's software in improving the pathologist experience and patient care.
Digital Pathology Revolutionizes Clinical Decision-Making
Pathology plays a crucial role in clinical decision-making, with up to 70% of decisions relying on pathology findings. Digital pathology is revolutionizing the field by replacing the traditional microscope with high-resolution images that contain over 1 billion pixels, providing valuable insights into a patient's disease and advancing precision medicine. Furthermore, digital pathology offers significant efficiency gains, which are particularly important as the number of new cancer cases in the United States is projected to exceed 2 million annually by 2024.
Proscia Expands Global Reach with Regulatory Clearances
In addition to the FDA clearance, Proscia has also obtained CE-IVDR certification, allowing it to advance primary diagnosis in the European Union. The company's products are also licensed in Canada and cleared in the United Kingdom, among other countries.
Proscia's Concentriq AP-Dx: Empowering Pathologists for Enhanced Diagnosis
Proscia's Concentriq AP-Dx represents a significant advancement in digital pathology, empowering pathologists with innovative tools to improve accuracy, efficiency, and collaboration. With its recent regulatory clearances, Proscia is poised to make a positive impact on cancer diagnosis and patient care worldwide.
