Search Results for 'guidance'
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Diagnostics
Qlarity Imaging Adds Breast MRI Biopsy Guidance to QuantX
A new 510(k) clearance expands the capacity of the first FDA-cleared computer-aided breast cancer diagnostic system.Business Wire 01.09.20
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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FDA Releases Draft Guidance to Enhance Breast Implant Safety Information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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Software & IT
HSCC Publishes Guidance on Cybersecurity Risk Management
Provides actionable guidance and practical tools.HSCC 10.16.19
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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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.”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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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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Contract Manufacturing
Mike on Medtech: FDA's Additive Manufacturing & 3D Printing Guidance
On this debut episode, MPO Editor Sean Fenske and regulatory guru Mike Drues examine the recently released guidance.Videos Sean Fenske, Editor
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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
