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NEWS FLASH: September 2000. Alcon/Summit/Autonomous obtains first FDA approval for New Eye Laser Use, Rockville, Maryland, March 17 (Bloomberg) Alcon, the flying spot laser manufacturer obtained the approval of the FDA for an expanded use of their eye laser system LADARVision. The U.S. Food and Drug Administration will allow the company to market the laser made by its Autonomous Technologies unit to treat farsightedness, with or without astigmatism and mixed astigmatism for LASIK. It's already approved for LASIK in nearsighted patients. This gives the LADARVision laser the widest range of approved treatments for LASIK. Currently it is the only laser system approved in the United States for LASIK for farsightedness. ``The sponsors did an excellent job in showing overall safety and efficacy,'' said Arthur Bradley, an associate professor at Indiana University, one of two panel members who reviewed the Summit data in detail during panel evaluation.
Includes Astigmatism
The FDA approved the device for a range of farsighted patients, including those with astigmatism, using a popular technique known as Lasik. Earlier today, the company said the lasers met all of FDA effectiveness criteria with few side effects. The success of the LADARVision laser, which Alcon acquired when it bought Summit Autonomous Technologies Corp. last year has been recognized with this approval. The LADARVision system an advanced laser that tracks the movement of the eye to better place the pulses of laser energy could give summit an edge as it tries to boost its share in the increasingly competitive eye laser market if it receives the expanded indication.
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NEWS FLASH: 11/29/98. Due to the excellent results Dr. Soloway obtained during CRS hyperopia clinical trials, he has been selected to participate in the hyperopia with astigmatism and consecutive hyperopia clinical trials. As one of only ten doctors in the United States, and the only doctor in the northeast, he will be able to provide a full range of correction to all patients, including those who have had surgery elsewhere and are unable to be corrected by their original surgeon.
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