MedTech Dive June 20, 2024
Elise Reuter

With the clearance, Globus could gain share in the roughly $15 billion market for reconstructive orthopedic surgery, RBC Capital Markets analyst Shagun Singh said.

Dive Brief:

  • Globus Medical received 510(k) clearance from the Food and Drug Administration for its ExcelsiusFlex orthopedics robot, according to a posting from the agency.
  • CEO Dan Scavilla said in a May investor call that Globus had filed a submission for a reconstruction robot with the FDA and expected clearance late in the third quarter. A June 14 filing describes ExcelsiusFlex as a device that provides stereotaxic guidance during orthopedic joint or spine surgeries.
  • RBC Capital Markets analyst Shagun Singh, who first pointed out the FDA’s notification in an emailed research note, said that Globus...

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Topics: FDA, Govt Agencies, Medical Devices
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