Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
Tag: FDA medical device safety
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FDA Orders Philips to Notify Patients of Recall of Certain Breathing Assistance Machines
The FDA issued a notification order to Philips Respironics requiring the company to of the recall of certain breathing assistance machines.
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FDA Warns of Medical Device Cybersecurity Vulnerability
FDA raised awareness of a cybersecurity vulnerability in Apache’s Log4j software library, which is used in medical devices and supporting systems.
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Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
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FDA: Stop New Implants of Medtronic Ventricular Assist Device System
The U.S. FDA is alerting healthcare providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device System due to safety concerns.
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FDA Seeks 8% Budget Boost for CDRH to Back Resurgence of Domestic Device Production
The U.S. FDA is proposing an increased Center for Devices and Radiological Health budget that would focus on fixing shortages and supply chain issues, reports MedTech Dive.
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FDA Issues Draft Guidances for Medical Device Studies after FDA Approval, Clearance
The U.S. FDA has issued guidance documents to help increase transparency and assist reporting and timely completion of studies on certain medical devices’ safety and effectiveness.
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Ransomware, Other Cyber Threats Mount as Medtech Industry Tries to Adapt
The U.S. FDA’s Kevin Fu is concerned about the increasing number and growing sophistication of cyberattacks on healthcare organizations, particularly their effect on medical devices and patient safety, reports MedTech Dive.
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FDA Issues Medical Device Safety Guidance for MRI Facilities
FDA’s final guidance for medical devices within MRI facilities highlights unique safety hazards, reports JD Supra.
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FDA Continues to Monitor Effects of Magnets in Consumer Electronics on Implanted Medical Devices
The U.S. FDA is taking steps to share information and preventive measures for patients and healthcare providers about the potential risks to implanted medical devices posed by magnets in new electronics like phones and smart watches, says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
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