Pathology in the Digital Era

Dr. Glassy and members of the Digital Pathology Association have participated in a number of meetings with the FDA to discuss the benefits of digital pathology and the potential risks that the technique may pose to patients. Dr. Glassy emphasized that, following these discussions, the FDA said that it would offer a less stringent review process for future digital pathology devices. Currently, digital pathology devices are categorized as class 3 devices, which are considered to carry the highest potential risk to patients and are therefore the most difficult to get approved. The FDA said that it would consider the next digital pathology device submitted for approval a “de novo” product, essentially making it easier for a new device to be approved.

Although FDA clearance is still pending for primary diagnosis, the FDA has cleared some digital pathology devices for image analysis) and for digital read of immunohistochemically-stained tissue slides, according to the FDA spokesperson.

According to Dr. Bauer, he and his colleagues are poised to adopt the use of digital pathology for primary diagnosis for a subset of cases once approved, given the successful results they’ve seen in their validation studies. “As work stations evolve and scanners become faster, there will be some role for digital pathology for primary diagnosis,” he said.

He expects that the first manufacturer to receive FDA approval for a digital pathology device to be used for primary diagnosis will probably occur later this year, with additional widespread approval and usage in the next year or two.

---

Mary Beth Nierengarten is a freelance medical writer based in Minnesota.