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Thoratec Should Sever Link Between International And U.S. Websites FDA

This article was originally published in The Gray Sheet

Executive Summary

Thoratec Laboratories Corp. disputes FDA's assertions in an Aug. 12 warning letter that the company misbranded its VAD device and inappropriately promoted its TLC-II portable VAD driver, which is currently under an approved investigational device exemption.

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Approval of a "bridge-to-transplant" indication for the BVS-5000 device has never been sought by the company, as was reported in "The Gray Sheet" (1Aug. 30, p. 11). The device is approved for temporary cardiac support for post-cardiotomy shock, cardiac transplant failure, myocarditis, and right-ventricular assist while the patient is on an implantable left ventricular assist device

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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