The Digital Pathology Association (DPA) is urging digital pathology manufacturers interested in marketing whole slide imaging (WSI) devices for primary diagnosis to submit do novo applications to the Food and Drug Administration (FDA). Currently, there are no existing FDA-approved digital pathology systems for clinical use, according to the Pittsburgh Business Times.
The global digital pathology market is expected to expand to $492.8 million by 2020, according to aTransparency Market Research report.
Omnyx, founded in 2008 by a partnership between GE Healthcare and the University of Pittsburgh Medical Center (UPMC), filed for FDA-approval of their system in 2014, at which time it was classified as a Class III device with the highest risk classification. But clarification on the FDA classification process is encouraging the application and approval process. For the full article click here
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