FDA Cardiology Committee

The FDA cardiology committee met to review external counterpulsation. They decided that EECP/ECP had been proven safe and effective in the treatment of refractory angina with patients in clinical studies to lower the classification from Class III to Class II. This permits EECP/ECP devices to be regulated under the 510(k) regulations.

By | 2017-06-15T15:10:42+00:00 June 14th, 2017|Comments Off on FDA Cardiology Committee