Johnson & Johnson wins FDA IDE for Ottava surgical robot

Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption (IDE).

The regulatory nod comes just under a month after the company announced that it submitted Ottava for IDE. It allows Johnson & Johnson MedTech to begin a clinical trial for the much-anticipated robotic platform at U.S. sites. The company is now preparing clinical trial sites to receive Ottava systems, enroll patients and begin surgical cases.

Johnson & Johnson first shared details on the Ottava surgical robotic platform about four years ago. However, since that day in November 2020, the company has remained quiet on the topic, though. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors.

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