FDA on pace for a Record Number of Breakthrough Devices in 2023
The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek...
FDA Grants Breakthrough Device Designation for EndoStim’s GERD Treatment
EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD). EndoStim states that its EndoStim...
