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Clinical Efficacy, Equivalence Concerns Hinder Embol-X Aortic Filter Review

This article was originally published in The Gray Sheet

Executive Summary

The difficulty of reconciling PMA clinical trial results with a 510(k) submission may hamper Embol-X, Inc.'s chances of achieving FDA clearance for its Embol-X aortic filter

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Edwards Enters Embolic Filtration Market With Embol-X Technology

Edwards Lifesciences will offer embolic filtration technology developed by Embol-X, Inc. for use during open-heart procedures such as valve replacement under an asset purchase valued at about $10 mil

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.




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