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
Robotic surgeries are designed to help emerging countries deal with complicated healthcare issues. But so far only one product, Intuitive Surgical's da Vinci system, is available and deployed worldwide. Now US National Science Foundation hopes that students hacking open-source surgical robots at universities in the U.S will spur more competition.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