Source: Medical Valley

Recently, the U.S. FDA approved the PHILPS intelligent network solutions (Philips IntelliSite Pathology pathology, Solution, Pips), which is the first can help interpret digital pathology image whole slice imaging system (whole slide imaging, WIS), the first WIS system for this purpose is approved by the FDA.
In vitro diagnostics and radiological health FDA office equipment and radiological health center director Alberto Gutierrez said in a statement: "this system allows pathologists to read slices through the digital way for diagnosis, rather than direct observation of tissue samples in the traditional optical microscope mounted on a glass slide. In addition, because the system will be stored in the digital section, or the physical file, it also provides a section of storage and retrieval system, the data provide a great convenience to pathology doctors and medical staff to get."
A pathologist is a physician who specializes in the understanding of the causes and development of disease or disease, and is the final diagnosis of the disease. In pathology, the case doctor installed biopsy tissue on slides and stained it for observation and evaluation. PHILPS's system uses proprietary hardware and software scans and digitized conventional pathological glass slides from biopsy tissue, which is equivalent to 400 times the magnification.
The US FDA reviewed PHILPS data through a new device with a low to medium risk. FDA said the approval was based on a clinical study of about 2000 cases of surgical pathology, which evaluated data from biopsies of multiple parts of the body (anatomy). The findings suggest that clinical interpretation based on PHILPS Pips images is equivalent to clinical interpretation (diagnosis) using glass film making.
This license, FDA is setting up special control measures must be satisfied, in order to ensure the accuracy of digital imaging system, the reliability and clinical relevance, the risks associated with the use of the technology and the use of conventional optical microscope is similar. These special control measures are necessary for providing a reasonable security and effectiveness for digital imaging systems.