J&J's Ottava robot wins FDA De Novo authorization, entering a $6B surgical robotics market long held by Intuitive Surgical. Shares rose 1.8%.
Johnson & Johnson (JNJ) on Wednesday said the FDA granted De Novo authorization for Ottava, the company's soft tissue robotic system. The clearance covers multi-quadrant surgeries, placing Ottava in direct competition with Intuitive Surgical's da Vinci platform, which has dominated the category for two decades.
J&J first showed Ottava in 2021 but delayed development after early technical setbacks. The system uses a bone-mounted base and independent arms, a design that differs from Intuitive's tower-and-cart setup. Surgeons can reposition arms during a procedure without undocking the robot, J&J said.
The De Novo pathway means Ottava is the first device of its type to receive this classification, giving J&J a regulatory foothold that competitors seeking 510(k) clearance would have to reference. The company did not disclose a launch date or pricing.
JNJ shares rose 1.8% on the news. The stock carries an Alpha Score of 64 out of 100, labeled Moderate, in the healthcare sector. The full profile is available on the JNJ stock page.
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