Globus Medical CEO Dan Scavilla said the company has had "direct conversations" with the FDA related to its spine robot in a Nov. 5 earnings call.
The FDA in August sent a letter to Globus Medical in July warning the devicemaker about an inspection related to the Excelsius GPS spine robot.
That warning was about the company's internal processes on how they handle complaints, Mr. Scavilla said.
"It was not directed toward the actual robot nor did it imply any issues with a robot or with patient safety … it was really about the array of criteria we selected when we're analyzing complaints," Mr. Scavilla said, as transcribed by Motley Fool. "The FDA would like us to do more, in which case we did. We went back to the very first complaint and went through every single one of them, realized that our outcome would not change with all the additional criteria."
Globus Medical remained in communication with the FDA, and Mr. Scavilla said he hopes the situation will be resolved within the year.
"Warning letters in the past from other companies tend to last in the year or excess of a year," Mr. Scavilla said. "So we're seeing if we can close that down and do that faster than that normal curve … We've had direct conversations with them. We've assured them in several different ways that it's not a product-related issue. And while there's some impact, I wouldn't quantify it, and I don't feel that it's been significant to date."