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Exact Sciences Completes Modular PMA For Cologuard

This article was originally published in The Gray Sheet

Executive Summary

The molecular diagnostics manufacturer submitted the final module of its PMA for Cologuard and expects to request Medicare coverage later this year through the FDA-CMS parallel review process.

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In the lead up to an FDA panel, positive data is published for Exact Science’s Cologuard multi-target stool DNA-based screening test. EndoChoice’s Fuse endoscope sees more colon cancer than traditional endoscopes. Overuse of neuroimaging for headaches documented. Long-term study finds high-frequency oscillatory ventilation is better for premature babies than standard ventilation. Drug-coated balloon trial.

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