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The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities. Read More
The FDA cut off imports from a Chinese manufacturer of hospital beds, stretchers and operating-room tables after an inspection discovered multiple violations of quality standards, the agency said in a warning letter. Read More
A German sunlamp manufacturer failed to measure up to several quality standards in an inspection of its plant in Berlin, and the FDA moved to bar imports from the company to the United States, the agency said in a warning letter. Read More
A federal judge ruled St. Jude may not dismiss a patient’s allegations over manufacturing-defects and negligence related to the company’s implantable cardiac defibrillator in a case filed with the U.S. District Court for the Northern District of California. Read More