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Top 10 Patient Safety Concerns for 2020
ECRI's annual report highlights patient safety concerns across the continuum of care.Slideshows ECRI 03.10.20
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FDA Offers Coronavirus Update Regarding Product Safety
The agency outlines the steps it will take to ensure the quality of foreign products.U.S. Food and Drug Administration 02.25.20
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Mike on Medtech: Safety and Performance Based 510(k)
Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.Sean Fenske, Editor-in-Chief 12.05.19
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Cardiovascular
ROADSTER-2 Demonstrates Compelling Patient Outcomes With Strong Safety Profile
The results continue to show the safety, effectiveness and clinical advantages of TCAR, as well as its short learning curve.Silk Road Medical Inc. 08.02.19
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Baxter Signs Open Data Pledge to Improve Patient Safety
Company is the 89th firm to commit to sharing data for the benefit of patients.Business Wire 02.12.19
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Surgical
FDA Updates Medical Device Safety Action Plan to Enhance Post-Market Safety
The agency aims to enhance medical device safety net and focus on several women's health devices.Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration 11.21.18
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FDA Releases Medical Device Safety Action Plan in Effort to Modernize Approach
Effort aims to enhance and modernize the FDA’s approach to medical device safety and innovation.Scott Gottlieb, M.D. 04.18.18
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Ten-Year Clinical Study Data Highlight Safety of MENTOR MemoryShape Gel Breast Implants
Latest data show product safety and effectiveness in primary and revision augmentation and reconstruction patients.Johnson & Johnson 03.12.18
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Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical | Testing
In Pursuit of Device Safety or a Call for Whistleblowers?
Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between t…Sean Fenske, Editor 03.07.17
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Contract Manufacturing
FDA Focuses on Improving Medical Device Safety
FDA Focuses on Improving Medical Device Safety James R. Ravitz, James H. Hartten Arent Fox PLLC James R. Ravitz James H. Hartten The US Food and Drug Administration (FDA) is under tremendous pressure to…James R. Ravitz and James H. Hartten 04.05.06
