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Former ODE Staffers Dispute Claims Of Office Corruption And Coercion

This article was originally published in The Gray Sheet

Executive Summary

Public censure of FDA's device center is escalating, but former Office of Device Evaluation staffers who spoke to "The Gray Sheet" paint a different picture of the review process than the corrupt image that has surfaced in recent months

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Research In Brief

CircuLite: NIH will grant CircuLite up to $3.7 million in a Fast-Track Phase I-II Small Business Innovation Research Grant to develop a pediatric circulatory assist device based on the same technology as the firm's Synergy Pocket Micro-pump, a small impeller-driven ventricular assist device about the size of a AA battery. Saddle Brook, N.J.-based CircuLite will collaborate with the University of Maryland School of Medicine on the project. CircuLite is currently conducting a European trial of Synergy Pocket Micro-pump (1"The Gray Sheet" Sept. 17, 2007)

Research In Brief

CircuLite: NIH will grant CircuLite up to $3.7 million in a Fast-Track Phase I-II Small Business Innovation Research Grant to develop a pediatric circulatory assist device based on the same technology as the firm's Synergy Pocket Micro-pump, a small impeller-driven ventricular assist device about the size of a AA battery. Saddle Brook, N.J.-based CircuLite will collaborate with the University of Maryland School of Medicine on the project. CircuLite is currently conducting a European trial of Synergy Pocket Micro-pump (1"The Gray Sheet" Sept. 17, 2007)

Do-Over? FDA Orders Look-Back At Knee Device 510(k) Review Process

In a sign of the intense scrutiny CDRH is facing under the new administration, FDA is taking the rare step of performing an internal review of its decision process for a recently 510(k)-cleared device. The inquiry could potentially lead to a "reconsideration" of the clearance, the agency says

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