The FDA is mulling new regulations that would give high-risk medical devices that address unmet medical needs a quicker approval process. MedPage Today reported the news, based on recent remarks made by Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. According to the story, Shuren said he was worried that U.S. patients face longer waits before they can use some devices due to FDA regulatory requirements. Shuren is also quoted as acknowledging that the regulatory status quo is beginning to push cardiac device makers to look outside of the U.S. and Europe for the initial launch of their products. Story