FDA-Approved Digital Pathology Systems Will Revolutionize Global Digital Pathology Systems Market

Published By : 28 Jan 2016 | Published By : QYRESEARCH

Digital pathology is an emerging technology which offers significant improvement across various applications such as diagnostic tests, drug discovery and development, and academic and research purposes. Developments in information technology and increasing favourable healthcare reforms have propelled the growth of the global digital pathology systems market. In addition, increasing workload of pathologists and rising healthcare spending has fuelled the demand for digital pathology systems. However, high initial setup cost, sampling error, and stringent regulatory compliance might delay the approval process of these systems, thereby reducing the adoption of digital pathology systems. 

New Technique to Offer High-Resolution Digital Microscopy Images

Researchers at the California NanoSystems Institute have developed a new technique to enhance the quality of digital microscopy images, thereby improving the resulting disease diagnoses. The new development might prove as a significant step for the production of digital imagery in microscopy. So far, digital imagery in microscopy has often led to blurry and pixilated images.

The new method, termed as wavelength scanning pixel super-resolution, captures a number of digital images of the same sample at different wavelengths of light. The captured pixels in each of the images are broken down into smaller pixels, thus producing a much higher-resolution digital image of the examined specimen.

First FDA-Approved Digital Pathology System Might Develop Soon

So far, manufacturers have not been able to comply with the stringent regulatory requirements set by the U.S. Food and Drug Administration (FDA) regarding the approval of digital pathology systems. However, the future looks positive with the following developments:

  • Omnyx, a company founded by GE Healthcare in partnership with the University of Pittsburgh Medical Center (UPMC) in 2008, might develop the first FDA-approved digital pathology system for clinical use.
  • Although Omnyx filed for FDA-approval in 2014, the system was classified as a Class III device, with the highest risk classification. However, the FDA has recently changed its status to a Class II device with fewer regulatory requirements.
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