BIG NEWS: The Dark Daily reports FDA Panel to Consider Digital Pathology and Whole Slide Imaging:
Next week, an FDA committee will consider whether to allow pathologists to use digital pathology systems for primary diagnosis. Even if the committee does not make a positive recommendation, the timing demonstrates the swift progress in the quality of digital pathology images and the systems that present them to the pathologists.
Digital pathology imaging systems are slowly replacing microscopes in the nation’s clinical labs. There is now enough momentum in the market for digital pathology imaging that the FDA’s Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee will meet October 22 and 23 in Gaithersburg, Maryland, to hear from experts in digital imaging. (See agenda) The FDA review committee may later make recommendations on the public health issues related to the use of digital whole slide imaging systems to replace conventional light microscopy for diagnostic surgical pathology.
I'm going to be presenting, as are many experts and participants in the digital pathology industry. It is no exaggeration to say this is one of the most pivitol hearings in the history of FDA regulation of Pathology. Stay tuned for a full report!
