Medical Device Network

J&J makes surgical robotic moves with Ottava FDA IDE application

After a two-year delay, J&J is ready to disrupt Intuitive’s market domination with Da Vinci.

One year after unveiling a timeline for its general surgical robot, Johnson & Johnson (J&J) has submitted an investigational device exemption (IDE) to the US Food and Drug Administration (FDA) as it eyes initiating clinical trials.

The company has remained tight-lipped on its technology, apart from saying last November that its IDE submission was planned for the second half of 2024 – making the application to the FDA right on time. J&J’s CEO Joaquin Duato announced the submission in the company’s Q3 financial results for 2024.

Johnson & Johnson first shared details on the Ottava surgical robotic platform nearly three years ago. At the time, the medtech giant said its device offered unrivalled flexibility and control compared with other robots on the market. The soft-tissue surgical robot has six arms and a zero-footprint design to increase space in the operating room, according to a release at the time.

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.

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, 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.

Medtronic joined the market in 2021, with a CE mark for its Hugo soft tissue system. Microbot is not far off an entry into the endovascular surgery market, with the company planning to submit a 510(k) application to the FDA later this year. Other companies in clinical trials with robotic systems include Vitestro and Ronovo Surgical.