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Digital pathology has been approved by the FDA for primary diagnosis. [16] The approval was based on a multi-center study of 1,992 cases in which whole-slide imaging (WSI) was shown to be non-inferior to microscopy across a wide range of surgical pathology specimens, sample types and stains. [17]
The functionalities that Applied Spectral Imaging provides laboratories and hospitals include automated slide scanning, applications interface, whole slide imaging, scoring and analysis, sharing capabilities for team review and final sign off, database management, secure archiving of reports, connectivity to the LIS and standardized testing.
Digital slides can be used as an alternative to traditional viewing for the purpose of teleconsultation. [ 2 ] The main virtual slide collection is the " Juan Rosai's collection of surgical pathology seminars ", curated by USCAP .
Prior to recent advances in virtual microscopy, slides were commonly digitized by various forms of film scanner and image resolutions rarely exceeded 5000 dpi. Nowadays, it is possible to achieve more than 100,000 dpi and thus resolutions approaching that visible under the optical microscope .
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Major topics of pathology informatics, including some that underlie telepathology: slide scanning, digital imaging and networks. Telepathology is the practice of pathology at a distance. It uses telecommunications technology to facilitate the transfer of image-rich pathology data between distant locations for the purposes of diagnosis ...
Dual source CT is an advanced scanner with a two X-ray tube detector system, unlike conventional single tube systems. [15] [16] These two detector systems are mounted on a single gantry at 90° in the same plane. [17] Dual Source CT scanners allow fast scanning with higher temporal resolution by acquiring a full CT slice in only half a rotation.
The 2002 Medical Device User Fee and Modernization Act (MDUFA) first granted FDA the authority to collect user fees from industry to help the FDA improve efficiency, quality, and predictability of medical device submission reviews; the medical device user fee program has been reauthorized several times with the most recent in 2022.