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Artemis VHF ultrasound device receives FDA approval
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ST. PETERSBURG, Fla. — Ultralink LLC received U.S. Food and Drug Administration 510K approval to market its Artemis very high frequency (VHF) digital ultrasound eye scanner. Company executives note Artemis is the world's first VHF scanner approved for use in the U.S. The FDA approved Artemis on May 22, 2001, to measure areas and thickness of components of the eye, according to company president George Wiseman.
Scans of the entire anterior segment by a patented, controlled curvature matching system permit accurate measurement for numerous refractive technologies, such as lens implants, Mr. Wiseman said. The device's digital signal processing technology provides images of the cornea and anterior segment of the human eye with resolution and precision to 1 µm.
The Artemis "will improve the safety of LASIK and can improve upon its already outstanding results. The device will strongly influence LASIK, particularly in the diagnosis and correction of complicated cases," said Dan Z. Reinstein, MD, FRCSC. "The device also has a critical role in the safety of phakic intraocular lens placement as well as in cataract, glaucoma, and corneal transplant surgeries."
Ultralink is in the process of applying for marketing approval for Artemis in countries outside the United States.
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