The FDA says it has approved a new blood test to identify victims of concussions and is conducting ongoing research to help better diagnose traumatic brain injuries.…
A proposed rule by the FDA could allow medical device manufacturers to simply summarize malfunction reports quarterly, instead of providing full, detailed information.…
A new report warns that while heart implants may be vulnerable to remote hacking, there is little likelihood of it actually happening, but the risk may grow in the future.…
The FDA has issued a new guidance on the 3D printing of medical devices and drugs, which are increasing in popularity in the medical field.…
A company accused of making inaccurate blood lead testing kits has received a warning letter from the FDA.…
The FDA has released a list of warnings and advice on using medical devices in disaster areas following two massive hurricane events in the U.S.…
Health analysts warn that emerging medical technology, if used incorrectly, can result in misdiagnosis and unnecessary treatments.…
A facility where lead testing kits were manufactured may have been in violation of federal standards, resulting in a warning about the accuracy of the tests in May, according to an FDA inspection report.…
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.…
