Patients with severe heart failure or cardiogenic shock often need mechanical circulatory support (MCS) devices but deciding ...
"Advances in cardiovascular medicine, such as minimally invasive cardiac procedures and modern mechanical circulatory ... could work to develop better preventive measures to lower the risk of ...
The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De Novo ...