Xcell to speed up US push
Wednesday, 10 September, 2003
Xcell Diagnostics (ASX:XEL) will accelerate plans to file for FDA approval of its microDERM video dermatoscope system, following a positive review of its programs by senior management and expert advisors.
The company now plans to file a 510(K) for the product by the end of 2003, with approval expected around April 2004. Independent European clinical trials of the system are also planned for 2004.
The product, originally developed by Xcell's German subsidiary Visiomed, already has FDA Classification I listing, but the company is seeking a higher classification to broaden its diagnostic and other claims.
Xcell has also appointed FDA consultant John Greenbaum to assist the group with its regulatory and clinical programs in the US. Greenbaum worked for Eli Lilly in a number of management positions and has cleared more than 75 new device applications through the FDA.
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