FDA JILTS GLOBUS ROBOT SYSTEM (Orthopedics This Week)
The FDA has informed Globus Medical, Inc. that the agency is not granting 510(k) clearance for the company's ExcelsiusGPS robotic guidance and navigation system.
The company issued an SEC filing on May 17, 2017 regarding the FDA's notification letter dated two days earlier.
The FDA letter, according to the company's filing, stated the agency does not believe the company has "sufficiently addressed" the agency's questions regarding the robotic system "within the FDA review period."
Globus management says it intends to file a revised 510(k) submission for the system in "an expedited fashion." Management also stated it remains confident in its ability to adequately satisfy all the issues identified by the FDA. The company said it had previously estimated that it was likely to receive FDA clearance to market the system in the second quarter of 2017. Management no longer expects that to happen.
Citing Globus management, Kyle Rose, an analyst at Canaccord Genuity Group, wrote in a report to clients, "The FDA has not expressed any concern" over the technology "and is confident" it can be approved.
The delay followed FDA requests for "a...
