New Artificial Heart Technology Earns FDA Breakthrough Device Designation
The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.
The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.
CorVista Health was granted Breakthrough Device Designation for a non-invasive diagnostic solution for those with pulmonary hypertension.
The Aethlon hemopurifier has been designated a "breakthrough device" by the U.S. FDA related to the treatment of life-threatening viruses not addressed with approved therapies. The proposed research entails an ex vivo evaluation of the medical device as a strategy for the capture and removal of exosomes from the plasma of patients with breast cancer.
The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.