
Wednesday, January 7, 2009
Nomir Medical gets second FDA clearance
By Mass High Tech staff
The U.S. Food and Drug Administration has granted medical devices firm Nomir Medical Technologies Inc. a second FDA 510(k) clearance of its Noveon system, intended to eliminate bacterial and fungal infections with photo-inactivation. The second FDA clearance enables the company to apply the Noveon system to skin, nasal and subcutaneous tissue procedures.
The Noveon system uses light to produce a photo-inactivation effect that rids bacterial and fungal infections but also helps maintain healthy tissue, the company reports.
Results from studies show the Noveon system effectively fighting the methicillin-resistant Staphylococcus aureus (MRSA) infection in the nose.
The firm has aimed its lasers primarily at toenail fungus since early 2006, after spending its first three years focused on treatments for tooth bacteria, Burtt said.
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