New guidelines from the FDA are an attempt to get the healthcare industry to take the necessary steps to prevent various forms of cyber attacks.Read More >
The makers of the da Vinci surgical robots are being probed by the U.S. Food And Drug Administration (FDA) following medical complications after some surgical procedures.Read More >
In Washington, Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.) co-authored legislation that would better regulate the fast-growing medical device industry.Read More >
In late December, the Food and Drug Administration (FDA) sent the pharmaceutical company Johnson & Johnson a letter warning of possible penalties for not reporting life-threatening vulnerabilities with its OneTouch Ping and 2020 insulin pumps. It is unclear whether the vulnerabilities are outright device failures or from interference or manipulation from outside sources.
After an inspection at Johnson & Johnson's subsidiary plant in West Chester, Pa., the FDA discovered one complaint about series patient injury and two other incidents never reported. According to the FDA one patient was hospitalized with diabetic ketoacidosis, a condition where the body does not have enough insulin. Another received high doses of insulin. And a third patient suffered serious injury, which could include coma, respiratory failure, and hypoglycemia as a result of user error.Read More >
New rules from the US Federal government should improve the security of medical devices and software that store, transfer or display data.Read More >
A drug infusion pump manufactured by CareFusion is being recalled due to a wireless communications error that can result in the interruption of drug delivery, which could ultimately result in serious injury or death. Due to the serious nature of the threat posed by this malfunction, the FDA has given the recall Class I status -- reserved for the most critical recalls.Read More >