After years of teasing an entry into the surgical robotics space, Johnson & Johnson (J&J) MedTech has completed a major step in progressing its system, winning an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for the technology.
The IDE will allow the medtech giant to conduct clinical trials at US sites with the robotic surgical system called Ottava. Such trials are needed to collect safety and effectiveness data to support market clearance applications.
J&J MedTech has not revealed further details about the clinical programme, saying only it “will now prepare clinical trial sites to receive Ottava systems, enrol patients, and begin surgical cases.”
The company first shared details on the Ottava robot nearly three years ago. Delays have meant that the surgery system was pushed back by two years – J&J cited the Covid-19 pandemic and technical challenges as factors.
The IDE grant marks the first time J&J has lifted the veils on the updated features of the robotic system. Ottava features four, low-profile robotic arms incorporated into the operating table that can be packed away underneath. The compact footprint is designed to support robotic, laparoscopic, hybrid, and open surgery, allowing more working space for clinical teams.
J&J highlights an element of the system named “twin motion”, the ability to move the table and robotic arms together during an operation for repositioning and multi-quadrant access without the need for re-docking.
Ottava will come with instruments made by Ethicon – a subsidiary of J&J with established presence in the surgical device sector. The company’s digital ecosystem, called Polyphonic and unveiled earlier this year, will provide Ottava with data and advanced insights to support clinical decision making.
J&J MedTech’s Ottava president Rocco De Bernardis said: “We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons.”
“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.”
Globally, the robotics industry is growing at a compound annual growth rate of 29% and will be worth $568bn by 2030, according to analysis by GlobalData. One of the most valued areas of robotics in healthcare is surgical procedures, with the surgical robotics market estimated to be worth $8.6bn in 2022 and projected to reach $10bn globally by the end of this year.
The company is looking to disrupt a market dominated by Intuitive Surgical, which was first to gain approval for soft tissue robot technology with its famous Da Vinci line in 2000. Intuitive brought in revenue of around $7.1bn in 2023, with the company having installed more than 8,600 robots globally as of March 2024. The company has a 60% share of the global robotic surgery market, according to analysis by GlobalData.
