The FDA is warning that some Datascope Intra-Aortic Balloon Pumps may experience electrical failures that could put patients at risk and have been linked to at least one death.…
Some tests used to check lead levels in the blood may be inaccurate, resulting in children with high lead levels being misdiagnosed and missing out on crucially needed care.…
The FDA warns that patient injuries and deaths have occurred when doctors used unapproved surgical navigation devices with Medtronic’s NavLock Tracker.…
An editorial by the New England Journal of Medicine warns that proposed provisions to reform medical malpractice claims by limiting non-economic damages and shielding doctors will not lead to lower costs or better healthcare.…
The FDA has published an editorial attempting to justify less reliance on clinical trials, despite growing concerns about medical device safety.…
Medical devices and hospitals are dangerously vulnerable to cybersecurity breaches, according to a presentation at a recent cybersecurity conference.…
The FDA has issued a final guidance for medical device manufacturers, detailing recommended steps in protecting remotely-accessible medical devices from cybersecurity threats.…
The FDA has issued new guidance determining when the public should be warned about adverse events linked to medical devices already on the market.…
The FDA is advising doctors not to use radiation medical devices by Multidata, which is under a consent decree not to sell them in the U.S.…
A preliminary report indicates that recalled heart implants cost Medicare $1.5 billion, raising calls for better tracking of medical devices.…
