FDAnews Device Daily Bulletin

CLEARANT ANNOUNCES TESTING, PACKAGING OF MEDICAL DEVICE; NEW STERILIZATION SYSTEM USED

Feb. 16, 2006
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Clearant, the developer of the patented Clearant Process for pathogen inactivation, has announced the processing and mechanical-integrity testing of a development-stage medical device in final packaging through the company's sterilization service. The sterilization service was recently launched to allow tissue banks and implant providers to use the company's sterilization technology. Clearant expects the unnamed device manufacturer to file a marketing authorization for the product with the FDA later this year.

"[Today's] announcement signals the first time that mechanical testing of the Clearant Process and the Clearant Sterilization Service have been successfully applied to a medical device product in its final packaging," said Alain Delongchamp, chief executive officer of Clearant. "By using our proven technology, we can provide the same level of sterilization to medical devices as the Clearant Process currently provides to tissue allograft implants."