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.
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
The FDA issued a notification order to Philips Respironics requiring the company to of the recall of certain breathing assistance machines.
FDA raised awareness of a cybersecurity vulnerability in Apache’s Log4j software library, which is used in medical devices and supporting systems.
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreFDA’s final guidance for medical devices within MRI facilities highlights unique safety hazards, reports JD Supra.
Read MoreThe 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.