The Food and Drug Administration has ruled that the premarket approval (PMA) application filed by Computerized Thermal Imaging for its thermal breast imaging system is not approvable in its current form. The FDA's decision concurs with the recommendation made by the agency's Radiological Devices Advisory Panel on December 10.
The FDA based its decision on issues regarding the clinical trial conducted in support of the application, and the company’s analysis of the clinical trial data, according to the Lake Oswego, OR-based firm. The FDA's letter to CTI also provided specific actions the company could take to place the PMA in an approvable form, CTI said.
The actions include completion of a new, focused premarket clinical study, revision of the indications for use of the device, and performance of a reproducibility study that takes into account variations that may be encountered in clinical practice, CTI said. In addition, the actions included the implementation of a validated clinical quality assurance/calibration procedure that users can perform on a daily basis to ensure the device is working properly.
President and COO John Brenna said CTI will continue to work with the FDA to determine the most efficient way to gain approval. The company is also exploring its options for appealing the decision and requesting a new review of the PMA application.
By AuntMinnie.com staff writersJanuary 28, 2003
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Thermal breast-imaging device fails to win FDA advisors' support, December 11, 2002
FDA sets new review date for thermal breast imaging system, October 16, 2002
CTI BCS 2100 slated for FDA panel review, July 25, 2002
CTI faces shareholder lawsuits, May 15, 2002
CTI to receive $22.5 million in financing, December 21, 2001
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