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R&D & Design | Software & IT | Testing
Transformative Testing: Addressing Patient Safety and Cybersecurity
With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.Mark Crawford, Contributing Writer 03.07.19
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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
Bayer & FDA Expand Essure Postmarket Safety Study by Two Years
Women in the study will be followed for five years, rather than the three years that was initially required.Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 01.02.19
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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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B. Braun Launches Safety Engineered Port Access Needle
Surecan Safety II designed to reduce the risk of needlestick injuries.Globe Newswire 11.02.18
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Zingbox Partners With the Medical Device Innovation, Safety and Security Consortium
Union will deliver key information to enable optimally configured and secured devices for patient safety and privacy.Business Wire 10.10.18
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Cardiovascular | Surgical
FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall
The AFX Endovascular AAA System recall was due to Type III endoleaks after endovascular aneurysm repair.Business Wire 10.08.18
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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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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
