The PreMD’s appeal over the NSE (not substantially equivalent) letter it received for a premarket submission to expand indications for its skin cholesterol test has been upheld by the FDA.  The FDA agreed that the clinical trial data was not sufficient to say if the product was substantially equivalent to other markers of cardiovascular risk.

General Electric Co.’s GE Healthcare unit has received FDA approval of its LightSpeed CT750 HD, the first high-definition computed tomography (CT) scanner. According to the company, the product improves image quality while reducing dose by up to 50% across the entire body and by as much as 83% for cardiac scans.

CVT Therapeutics Inc. has received FDA approval for its injection for the detection of coronary artery disease . The Lexiscan injection is designed as a pharmacologic stress agent in the testing to detect and characterize coronary artery disease for patients who are unable to undergo adequate exercise stress.

Vision-Sciences Inc. has received FDA approval for its 510(k) submission to market its advanced digital, video-based cystoscope line. The cystoscope line is meant to be used along with an integrated built-in light source, eliminating the need for a separate camera head, light guide cable and optical coupler. These lightweight videoscopes facilitate diagnostic and therapeutic procedures with the introduction of the world’s smallest diameter videoscope insertion tube containing a high resolution, miniature CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition, vibrant, full screen image.