FDA Approval of First Digital Pathology System Close to Reality, Cancer Diagnostics to reach new Heights from here


Published Date : Jan 28, 2016

In the 20th-century, the technology for cancer diagnostics involves slides and microscopes. In the bid to improve cancer diagnostics, healthcare corporations and medical devices companies are entering into partnership to find the formidable treatment for the lethal disease. In this regard, in 2008, the University of Pittsburgh Medical College and GE Healthcare, which is a division of the General Electric Co., entered into a partnership to create Omnyx. 

Omnyx was created with the aim to develop the first digital pathology system to receive certification from the U.S. Food and Drug Administration to be used for clinical purposes. The system was developed with the intent to bring diagnosis of cancer into the 21st century. Seven years, thence, the aim of the two partnering companies seems to be close. 

In the U.S., the Digital Pathology Association – a nonprofit group comprising of scientists, technologists, and scientists who proselytize for the research possibilities of 21st century digital pathology systems announced something important. In the new release presented by the association, companies like Omnyx were encouraged to submit applications to the FDA to receive approval for ‘whole slide imaging devices’, which are also known as digital pathology systems. 

This is because, FDA has changed the classification of these devices from Class III to Class II, a category that requires fewer regulatory hurdles from its former category of highest risk products. Prior to this, there is no device that has FDA’s approval to be used as digital pathology system for clinical purposes. 

Digital Pathology Systems – a Glance

Digital pathology is the process, wherein computer technology is used for the purpose of converting an analog microscopic image into digital format. The system is characterized with the creating, managing, storing, sharing, and interpreting digital image from a glass slide with the help of computer technology. 

Digital pathology offers several benefits. First and foremost, the utilization of these system offers accurate diagnosis, which is enabled with a standard procedure for test interpretation and workflow. For these reasons, digital pathology systems are utilizable in hospitals, medical universities, research organizations, and government organizations. 

On the application perspective, digital pathology systems are suitable for both human and animal pathology. In terms of advantage of these systems, laboratory information system can be merged with digital pathology systems for information integration.