Salt Lake-based BSD Medical Corp. said Wednesday that that U.S. Food and Drug Administration has told the company that BSD's written response to an FDA warning letter is adequate.
BSD said the FDA's concerns had been limited to research conducted at a clinical site and had nothing to do with the safety, efficacy, quality, design or manufacture of BSD's equipment.
"Implementations of the corrective actions you have developed and implemented appear to be adequate," the FDA replied, noting further that "no response to this letter is necessary."
Research at the site was not funded by BSD, the company said, adding that it was closed to treating patients since Aug. 31, 2006.
BSD develops systems that deliver radio-frequency and microwave energy to treat cancer.