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FDA approval for the Dark Ages

This article was originally published in The Gray Sheet

Executive Summary

Ricarimpex SAS becomes first firm to apply for and receive 510(k) clearance for fresh-water leeches as medical devices. Hirudo medicinalis, considered a pre-amendment device, is indicated to heal skin grafts and restore circulation in blocked veins by removing pooled blood. Leeches "have been used as an alternative treatment to blood-letting and amputation for several thousand years," FDA notes. The French firm has bred the devices for 150 years...
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