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
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 More
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.Read More
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.Read More
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.Read More
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.Read More
FDA’s final guidance for medical devices within MRI facilities highlights unique safety hazards, reports JD Supra.Read More