Paradigm Submits Results, Seeks FDA Approvalof Laser Cataract Removal
SALT LAKE CITY, Dec. 9 -- Paradigm Medical Industries Inc. has submitted to the US Food and Drug Administration results from recent clinical trials of its laser cataract removal system -- the Photon -- along with a notice of intent to market the technology. We are pleased with the clinical performance of the Photon and, together with legislation recently enacted which allows for the inclusion of results using the device from sites outside the US, we feel the approval will be expedited, said Thomas Motter, Paradigm's CEO.
Motter continued, We believe the laser removal technology is an easier, safer, more user-friendly way to take out cataracts and should replace the current ultrasound needle technology which, under some conditions, is dangerous.
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