Focus nets clearance for CardioMatch

Focus Medical has received Food and Drug Administration 510(k) clearance for CardioMatch, a 3-D image analysis software program designed to improve the specificity of a myocardial perfusion study. The Belmont, CA-based company is also in final negotiations with a major medical university and hospital group in Northern California to perform a large clinical validation study using CardioMatch.

CardioMatch has been cleared as a cardiac diagnostic software program to quantitatively analyze myocardial perfusion in patients injected with Cardiolite or thallium-201 following a rest/stress SPECT acquisition protocol. The company unveiled CardioMatch at the annual meeting of the Society of Nuclear Medicine in June (SCAN Special Report 6/97).

Focus plans to continue to pursue new applications for its image analysis technology. The firm expects to file a 510(k) application in the fourth quarter for PneumoMatch, which is targeted at the early detection, quantitation, and 3-D visualization of pulmonary embolism. Additional neurological and oncologic applications are also on the drawing board.