FDA says “NO” to the new robot system from Globus Medical

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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) s...

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