Proscia’s Concentriq AP-Dx Receives FDA 510(k) Clearance for Primary Cancer Diagnosis

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Proscia Receives FDA 510(k) Clearance for Concentriq AP-Dx

  • Proscia’s Concentriq AP-Dx receives 510(k) clearance from the FDA for primary diagnosis
  • Concentriq AP-Dx is a diagnostic software solution designed to streamline collaboration and broaden access to expertise in clinical settings of all sizes
  • Clinical study at PathGroup, South Bend Medical Foundation, and Spectrum Healthcare Partners demonstrates non-inferior diagnoses to traditional glass slide reads
  • Proscia also achieves CE-IVDR certification to advance primary diagnosis in the European Union and has a product licensed in Canada and cleared in the United Kingdom
  • Proscia Receives FDA 510(k) Clearance for Concentriq AP-Dx

    Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis.

    Advancing Cancer Diagnosis with Digital Pathology

    Up to 70% of clinical decisions depend on pathology, and digital pathology is shifting the standard from microscope to high-resolution images containing over 1 billion pixels. This technology holds the key to advancing precision medicine and driving efficiency gains to help laboratories overcome systemic challenges.

    Supporting Pathologists in the Fight Against Cancer

    With 510(k) clearance, Proscia can help more laboratories improve the pathologist experience and better serve their patients. The company’s commitment to perfecting cancer diagnosis is reflected in its regulatory milestones and certifications to advance primary diagnosis in multiple countries.

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