A rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical Inc. may pressure hospitals to bolster training for doctors using the $1.5 million device.
High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.
The U.S. Food and Drug Administration warned doctors and patients against the use of an unproven procedure known as “liberation therapy” that some physicians have touted as a treatment for multiple sclerosis.
Medical device makers Medtronic Inc. , Johnson & Johnson and Stryker Corp . face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.