Globus Medical, Inc.

Globus Medical, Inc. develops and manufactures orthopedic medical devices, including spinal implants and surgical robotics systems. As part of its product development and regulatory clearance process, the company conducts pre-clinical testing that includes animal experiments. A 2022 academic paper on surgical robot development cited Globus Medical's technology and noted that "in the early stages, animal experiments confirmed the accuracy" of similar robotic systems. The company's regulatory filings with the SEC reference its "mechanical testing laboratory" and the use of "pre-clinical studies" to support applications for FDA clearance.

The U.S. Food and Drug Administration (FDA) issued a warning letter to Globus Medical on July 15, 2024, citing violations of applicable regulations noted during a facility inspection. The agency stated the firm failed to provide documentation to demonstrate completion of all corrective actions. This regulatory action underscores the company's ongoing engagement with FDA-mandated testing protocols, which for implantable devices routinely include animal testing to demonstrate safety and efficacy.