March 14, 2024 - Intuitive Surgical (NASDAQ: ISRG) announced today that its highly anticipated next-generation robotic surgical system, da Vinci 5, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory milestone marks a significant advancement in the field of robotic-assisted surgery.
The da Vinci 5 system builds upon decades of technological expertise and the successful track record of the da Vinci Xi system, which has revolutionized surgical procedures worldwide. With over 7 million surgeries performed, the da Vinci platform has consistently demonstrated its effectiveness and reliability.
The da Vinci 5 robotic system introduces over 150 enhancements designed to further elevate surgical precision and improve patient outcomes. Key features of the da Vinci 5 system include:
1. Improved Accuracy and Precision
The da Vinci 5 system incorporates a new surgeon console with enhanced tremor control, allowing for unparalleled accuracy and precision during surgical procedures. Surgeons can experience smoother movements and more precise control, leading to improved surgical outcomes.
2. Next-Generation 3D Display and Imaging
Equipped with the latest 3D imaging technology, the da Vinci 5 system offers surgeons a more comprehensive and natural view of the surgical field. This advanced imaging system provides enhanced depth perception and clarity, enabling surgeons to make informed decisions with confidence.
3. Groundbreaking Force Sensing Technology
da Vinci 5 introduces force feedback technology, a groundbreaking feature that measures the forces exerted on human tissue during surgery. Surgeons can now experience a sense of touch, allowing for delicate manipulation and potentially reducing trauma to the tissue. This technology opens new possibilities for data analysis and surgical data science, paving the way for further advancements in robotic surgery.
4. Enhanced Surgical Efficiency and Workflow
The da Vinci 5 system is designed to streamline surgical workflows and improve efficiency in the operating room. With integrated operating room technologies and an optimized user interface, surgical teams can access key settings directly from the head-mounted display menu, reducing the need for manual adjustments and saving valuable surgical time.
5. Expanded Computing Power and Advanced Data Processing
Featuring computing power over 10,000 times greater than its predecessor, the da Vinci 5 system enables advanced digital experiences and integration with Intuitive Surgical's suite of surgical technologies. Surgeons can leverage the My Intuitive app, SimNow virtual reality simulator, Case Insights computer monitor, and Intuitive Hub digital surgical system for enhanced surgical planning, training, and analysis.
6. Enhanced Surgeon Comfort
The newly designed console of the da Vinci 5 system offers improved ergonomics and adjustability, allowing surgeons to find their most comfortable and optimal viewing angles. Surgeons can make necessary adjustments while wearing the head-mounted display, ensuring a personalized and comfortable surgical experience.
Gary Guthart, CEO of Intuitive Surgical, expressed his enthusiasm for the FDA clearance: "We are pleased that our fifth-generation robotic system, da Vinci 5, has received FDA clearance. Intuitive is committed to pushing the boundaries of surgical technology to deliver better patient outcomes and enhance the surgical experience. After years of meticulous research and development, we believe da Vinci 5 will play a pivotal role in the future of robotic-assisted surgery."
Dr. Myriam J. Curet, Chief Medical Officer of Intuitive Surgical, shared her perspective: "We continuously strive to address the needs of our customers and tackle important challenges in surgery. With the FDA clearance of da Vinci 5, we plan to further expand its availability in the United States and globally. We remain dedicated to ongoing innovation and development in the da Vinci robotic system, integrating new features, indications, and instruments to advance the field of robotic surgery."
da Vinci 5 is the latest addition to the da Vinci surgical robot series, which includes the multi-port robotic systems da Vinci X and da Vinci Xi, as well as the single-port system da Vinci SP. They provide surgeons and hospitals with powerful and validated solutions from Intuitive Surgical.
Intuitive Surgical will hold a conference call on March 18, 2024, to discuss the features and advantages of da Vinci 5, as well as the company's release plans.
About Intuitive Surgical
Intuitive Surgical is a global leader in robotic-assisted minimally invasive surgical technologies. Founded in 1995 and headquartered in Sunnyvale, California, United States, the company is dedicated to developing innovative surgical robot technologies. Its product portfolio includes the da Vinci Surgical System and the Ion Minimally Invasive Lung Biopsy System. The da Vinci surgical robot system is one of the most popular and widely used surgical robot systems in the market. The system enables surgeons to perform various surgeries through small incisions, improving surgical efficiency and safety while reducing patient complications and recovery time.
For more information, please visit:https://www.intuitive.com/