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February 6 – February 11

February 9th: Heidelberg Engineering Receives FDA Clearance for Slit Lamp-Mounted Anterior Segment OCT

Heidelberg Engineering GmbH has received U.S. Food and Drug Administration (FDA) clearance for the company's pioneering SL-OCT(TM) product, the world's first commercial optical coherence tomography (OCT) device used for cross-sectional anterior segment imaging. The SL-OCT was first introduced in Europe, receiving CE mark certification in 2003.

The device is innovative in two ways: Not only is it the first commercial application of OCT for anterior segment imaging, but its mounting on a slit lamp offers users both space savings and cost advantages. The SL-OCT provides easy-to-use, noncontact cross-sectional scans of the anterior segment. Chamber angle, pachymetry, flap thickness, corneal curvature and comprehensive biometric measurements are possible with the instrument, as well as pre- and post-surgical comparisons.

Headquartered in Heidelberg, Germany, the privately-held company is the leader in light-based diagnostics for ophthalmic applications and has the world’s largest installed base of laser imaging equipment. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases.

February 10th: FDA Approves For Technology to Treat Patients with Heart Rhythm Disease

The U.S. Food and Drug Administration (FDA) today approved an innovative combination of technologies that will enhance a doctors' ability to treat patients with abnormal heart rhythms (cardiac arrhythmias). The approval results in the first and only commercially available products for use during cardiac radiofrequency ablation with the Niobe® Magnetic Navigation System, designed by Stereotaxis, Inc. and the CARTO RMT System from Biosense Webster, Inc. Cardiac radiofrequency ablation is a non-surgical procedure during which a catheter delivers energy to damaged heart tissue to restore normal heart rhythms. Cardiac arrhythmias affect millions of people nationwide.

The FDA approval covers the use of the NAVISTAR® RMT Diagnostic/Ablation Steerable Tip Catheter with the Niobe® System. Biosense Webster offers the only products that work with the Stereotaxis system to enable electrophysiologists (doctors that treat the heart's electrical system) to steer a catheter remotely, map the electrical activity of the heart, and ablate targeted areas that require treatment. Biosense Webster Inc, a Johnson & Johnson Company, pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools.
 

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