Johnson & Johnson MedTech Gains FDA Approval for Clinical Trials of OTTAVA™ Robotic Surgical System
Johnson & Johnson MedTech has received FDA approval for an Investigational Device Exemption (IDE) for its OTTAVA™ robotic surgical system, marking a critical step toward launching clinical trials at U.S. sites. With this IDE, the company will prepare trial sites, enroll patients, and initiate surgical procedures, positioning OTTAVA as a pioneering platform in robotic surgery. The OTTAVA system is part of Johnson & Johnson MedTech’s expanding surgical technology portfolio, designed to meet the evolving needs of hospitals and healthcare providers and to broaden the accessibility of robotic-assisted surgeries in a high-growth, competitive market.
“The OTTAVA system embodies J&J MedTech’s commitment to advancing surgical innovation,” stated Hani Abouhalka, Company Group Chairman, Surgery at Johnson & Johnson MedTech. “Our aim is to enhance surgical experiences across all modalities, making procedures more adaptive and connected to better serve patients worldwide.” Rocco De Bernardis, President of OTTAVA, echoed the sentiment, highlighting the company’s focus on training clinical trial teams to ensure a seamless transition to trial phases.
The OTTAVA system is built to redefine modern operating rooms through its unique four-arm robotic setup, integrated into the operating table to optimize space. Ethicon, a trusted name in surgical instrumentation, powers the system, providing consistent quality across laparoscopic and robotic procedures. Further enhancing OTTAVA’s capabilities, Johnson & Johnson MedTech’s Polyphonic™ digital ecosystem will empower real-time data insights to assist surgical decision-making and foster collaboration among surgical teams globally.
