Somanetics Announces New FDA 510(K) Clearance (Medical News Today)
Somanetics Corporation (Nasdaq: SMTS) announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS(R) Cerebral/Somatic Oximeter. The new labeling allows a claim of improved patient outcomes after surgery when the INVOS System is used to manage therapies in patients above 2.5 kilograms (kg) at risk for reduced or absent blood flow.

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R) (PR Newswire via Yahoo! Finance)
Thoratec Corporation , a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has filed a PMA supplement with the FDA seeking to add the intended use of Destination Therapy