Now, a group of researchers led by Oxford University and Weill Cornell Medicine have proposed a new framework to make sure that such devices get better scrutiny.
Writing in the June 9 issue of BMJ, the researchers compare the existing approaches to evaluation of medical devices in both the United States and the European Union — where manufacturers have to prove only that a device is safe to get approval to sell it — with an integrated evaluation pathway for demonstrating that devices are both safe and effective.