Johnson & Johnson MedTech has received U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval to begin a U.S. clinical trial of its Ottava robotic surgical system.

The company said Ottava was designed to set a new standard for the modern operating room. It has a unique, unified architecture, Ethicon surgical instrumentation, and a digital ecosystem to provide versatility for patient needs and surgeon clinical approach.

Ottava features four, low-profile robotic arms incorporated into the operating table, which can be stowed underneath the table. Its unified architecture provides a compact footprint that can support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.

The surgical robot will exclusively feature Ethicon instrumentation, designed for a more consistent experience between traditional laparoscopic and robotic procedures. J&J MedTech’s Polyphonic digital ecosystem will connect the company’s portfolio of surgical technologies, robotics, and software.

Polyphonic will also empower the Ottava system with data and advanced insights to support clinical decision making, learning, and collaboration.

“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.”

“We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,” added Rocco De Bernardis, President, OTTAVA, Johnson & Johnson MedTech. “With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.”