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Electronics
Home Healthcare: How the IEC 60601-1-11 Standard Impacts Power Safety Requirements
Additional measures must be taken to ensure equipment remains safe for use in the home environment.Dylan Howes, Applications Engineer, TT Electronics 01.29.20
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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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Surgical
FDA Offers Update on Efforts to Ensure Breast Implant Safety
FDA hopes to ensure that women have the most complete information available to make important breast implant decisions.Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner; Jeff Shuren, M.D., J.D., CDRH Director 05.06.19
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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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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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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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R&D & Design | Testing
On the Hill: Device Safety Act Could Have Hodgepodge Effect
Device Safety Act could have hodgepodge effect.Thomas C. Novelli 03.31.09
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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
