A recent study led by Dr. Kushal T. Kadakia from Harvard Medical School found that nearly 10% of FDA-authorized therapeutic breakthrough devices entered the market without premarket clinical testing. The research evaluated 1,041 devices approved under the Breakthrough Devices Program from 2016 to 2024, revealing that 75 therapeutic devices were authorized, with 34 categorized as high-risk. Despite most devices being reviewed in statutory timelines, concerns were raised regarding the robustness of clinical evidence supporting these devices, particularly regarding efficacy measures.

Source: JAMA Internal Medicine