JnJ MedTech gets IDE approval for OTTAVA Robotic Surgical System

New Brunswick: Johnson & Johnson MedTech has announced that the U.S. Food & Drug Administration (USFDA) has approved the OTTAVA robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites. The Company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.
Johnson & Johnson MedTech is building on its global portfolio of surgical technologies to advance OTTAVA and help surgical teams and hospitals provide more patients with the benefits of robotic surgery. The system is designed to address unmet needs that persist in robotic surgery today, while driving choice and competition in an underpenetrated and high-growth market.
“We are bringing the best of J&J MedTech’s surgery expertise to the OTTAVA system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “Meeting this milestone brings us a step closer to delivering on our promise to make technology more human, care more adaptive, and people more connected so that surgery works better for everyone.”
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