Intuitive Surgical has officially submitted a request for FDA 510(k) clearance for its upcoming da Vinci 5 multiport surgical robot, aiming to expand its current robotic surgical system offerings. The da Vinci 5 is designed to complement the existing multiport X and Xi systems, as well as the single-port SP and Ion, a robotic-assisted platform for lung biopsies.
Anticipation and Market Response
The announcement of the da Vinci 5’s progression has been eagerly awaited, as Intuitive had previously not disclosed specific launch timelines. This follows a period of investor concern after the company announced that a new multiport system would not be launched in 2023, causing a temporary drop in stock value. However, upon the recent news, Intuitive’s shares experienced a more than 6% increase, indicating positive market reception.
Regulatory Progress and Production Plans
Intuitive has completed a comprehensive multicenter trial for the da Vinci 5, submitting for clearance in August 2023, and is actively engaging with the FDA. The company is also initiating discussions with Japanese and South Korean regulators. To prepare for the da Vinci 5’s production, manufacturing for the X system has been moved to the East Coast, with the Xi system to follow, and new facilities are slated for opening in California within the next 18 months.
Intuitive’s CFO Jamie Samath expressed confidence that these strategic moves will ensure superior supply availability, product quality, and cost-effectiveness. Further details about the da Vinci 5 will be revealed post-FDA clearance, with the company believing that a diverse portfolio will benefit hospitals.
Financial Performance Exceeds Expectations
In addition to the da Vinci 5 news, Intuitive reported a successful fourth quarter in 2023, surpassing Wall Street expectations with a 17% increase in revenue and significant growth in net income and worldwide da Vinci procedures. The company’s financial strength and market performance underscore its leading position in the robotic surgery industry.
