Paradigm Medical Industries Inc., 1772 W. 2300 South, has received approval from the Food and Drug Administration to use its new laser-assisted cataract removal system in the first phase of clinical trials in the United States.
The company applied for investigational device exemption status to provide safety and performance data to support its FDA pre-market notification submission for the new laser system.Paradigm will install its first system at Murphy Hospital in North Carolina under the direction of Dr. Daniel Eichenbaum, who will be the lead monitor in the program. Clinical use is expected to begin in 60 days.
Company officials say their computer-aided laser cataract system is safer and easier to use than conventional ultrasound systems now on the market. Surveys show that 42 percent of 15,800 ophthalmic surgeons anticipate using a laser system to remove cataracts.