Globus Medical said yesterday that the FDA won’t accept the 510(k) clearance bid for its ExcelsiusGPS robot-assisted surgery platform, likely delaying its launch until the 3rd quarter.
Globus said in a regulatory filing that the federal safety watchdog told it that the company hadn’t “sufficiently addressed the FDA’s questions” about its original clearance application. Audubon, Pa.-based Globus said it plans to file a revised application “in an expedited fashion.”
“We remain confident in our ability to adequately satisfy all of the issues identified by the FDA,” the company said in the filing.
