Search Results for 'guidance'
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Surgical
FDA Releases Draft Guidance to Enhance Breast Implant Safety Information
FDA recommends including a boxed warning and other elements in breast implant labeling.U.S. Food and Drug Administration 10.28.19
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3D/Additive Manufacturing
FDA Announces 3D Printed Medical Device Guidance
World’s first agency to provide a comprehensive technical framework for 3D printed medical product manufacturing.Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 12.06.17
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NICE Provides Positive Guidance for Use of the XprESS Multi-Sinus Dilation System
Studies show treatment with XprESS Multi-Sinus Dilation System leads to a rapid, sustained improvement in chronic symptoms.Entellus Medical Inc. 12.15.16
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R&D & Design | Software & IT | Testing
FDA Updating Guidance on 510(k) Submissions for Product Software Changes
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.” This new guidance document applies to software changes only, and addresses t…James A. Dunning, CEO, QPC Services 10.12.16
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Contract Manufacturing | R&D & Design | Software & IT | Testing
Mike on Medtech: Guidance on Medical Device Changes Submitted to FDA
In August, the FDA released guidances offering insight on what changes need to be reported to the agency.Videos Sean Fenske, Editor
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Software & IT
FDA Clears Cydar EV 3D Surgical Guidance Software
Cydar EV uses high-performance cloud computing to provide surgical guidance in operating rooms.PR Newswire 07.21.16
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FDA Clears Expanded Indications for Medtronic’s Sinus Dilation System with Image Guidance
Clinical study conducted on revision subjects support expanded indication for patients with surgically altered tissue.Medtronic 07.12.16
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Cardiovascular | Electronics | R&D & Design
FDA Releases Draft Guidance on Adaptive Clinical Trial Design
Device firms should take the time to determine whether an adaptive design is appropriate, consultant suggests.Online Exclusives Christopher Delporte, Editorial Director 06.11.15
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The Newest Vigilance Guidance Explained
The Newest Vigilance Guidance Explained Evangeline Loh The C arm on an X-ray vascular system used during a patient examination exhibited uncontrolled motion. The patient was hit by the imag…05.02.07
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R&D & Design | Testing
FDA Issues Guidance for Wireless Device Makers
The U.S. Food and Drug Administration (FDA) has issued its most up-to-date guidance on wireless medical devices. Released by the FDA’s Center for Devices and Radiological Health (CDRH), it is titled “Guidance for Industry and Food and Dru…11.30.-1
