A Breakthrough-Friendly Regulatory Environment

FDA's breakthrough devices program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. The agency has been rapidly accepting devices into this pathway this year. Products that have been granted a breakthrough device designation in 2019 include an artificial meniscus, a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, an interatrial shunt for heart failure from V-Wave, B. Braun's drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronary intravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze, and two cancer diagnostic tests.

Wondering if your product meets the criteria? Here's where you can find out.