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Intuitive Surgical, Inc. Receives FDA Clearance for da Vinci 5 Robotic System

Intuitive Surgical, Inc. (NASDAQ:ISRG) has received 510(k) clearance from the U.S. Food and Drug Administration for its latest product, the da Vinci 5. This new generation multiport robotic system is poised to enhance minimally invasive surgery with more than 150 improvements over its predecessor, the da Vinci Xi.

The da Vinci 5 system boasts improved accuracy and precision, with new surgeon controllers and advanced controls to reduce vibration and tremor. Its next-generation 3D display and image processing promise to provide surgeons with high-quality, natural imagery, supporting future surgical technologies.

A notable innovation in the da Vinci 5 is the introduction of Force Feedback technology, allowing surgeons to feel the forces exerted on tissue during surgery, a feature not available in any other surgical modality. In preclinical trials, this technology demonstrated up to 43% less force exerted on tissue, suggesting the potential for reduced trauma.

The system also aims to improve operating room efficiency through integrated technologies and an optimized user interface that can be accessed by the surgical team. Da Vinci 5’s computing power exceeds that of the da Vinci Xi by a factor of more than 10,000, enabling advanced digital experiences and system capabilities.

Designed with surgeon comfort in mind, the console allows for customizable positioning, including upright sitting, catering to various body types and accommodating surgeons during pregnancy.

Initially, the da Vinci 5 will be available to select U.S. customers who participated in the development process and those with established robotic surgery programs. Intuitive plans to gather additional data from these initial sites before commencing a broader commercial rollout.

The da Vinci 5 is the latest addition to Intuitive’s product line, which includes the da Vinci X, Xi, and the single-port da Vinci SP. The company envisions continued development and integration of new functions and capabilities into its systems.

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