A new US pathway aimed to align approval and insurance review for breakthrough medical devices, cutting potential coverage waits to ~2 mo from >1 yr.
The program covered breakthrough technologies addressing unmet medical needs, moving insurance review earlier in development while those devices already received faster federal approval.
Officials said the pathway still had to clear rulemaking, including ~2 mo of public comment, before implementation could begin.
Examples included artificial heart valves, heart-rhythm devices, and nerve-stimulating implants used to treat disease.
Federal officials said 40 devices were already eligible, with another 20 potentially joining the program.
