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Datascope Recalls Cardiosave Pumps Over Alarm

[ Price : $8.95]

Datascope begins an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due t...

Enhanced Drug Distribution Security Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security at the Package Level Un...

Guide on Real-World Data/Evidence

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Considerations for the Use of Real-World Data and Real-Worl...

AdvaMed on At-Home Medical Technology Use

[ Price : $8.95]

AdvaMed lists steps the federal government could take to improve patient access to at-home medical technologies.

Alcrestas ReliZorb Cleared for Younger Children

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FDA clears an Alcresta Therapeutics 510(k) for an expanded use for ReliZorb in children ages two to five years.

Blood Monitor Cleared for Cardiopulmonary Bypass

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FDA clears a LivaNova 510(k) for its Essenz In-Line Blood Monitor that provides continuous measurement of essential blood paramete...

Fight Bone Graft Infections: Michigan Lawmakers

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Four members of Congress from Michigan call on FDA to do more to prevent infections from contaminated bone grafts.

Keep FDA Logo Out of Materials: Agency

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FDA reminds industry and others about its policy on using the FDA name and logo in any materials without being specifically author...

FDA Quality Management White Paper

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FDA publishes a white paper on the assessment approach to be used as part of CDERs Quality Management Maturity program.

Opioid Crisis Worse Despite Progress: Califf

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FDA commissioner Robert Califf says much remains to be done to combat the changing opioid crisis in the U.S.