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NEW YORK ─ Computational pathology firm Paige said on Tuesday that it has received US Food and Drug Administration 510(k) clearance for use of its FullFocus digital pathology image viewer with the Philips Ultra Fast scanner for primary diagnosis.

The clearance paves the way for the in vitro diagnostic use of FullFocus with additional IVD whole slide imaging (WSI) scanners, Paige said.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.