Intuitive secures FDA clearance for da Vinci 5 surgical robotic

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Intuitive secures FDA clearance for da Vinci 5 surgical robotic


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Intuitive secures FDA clearance for da Vinci 5 surgical robotic

The full Intuitive Surgical da Vinci 5 surgical robotic system. | Credit: Intuitive Surgical

Intuitive Surgical (NASDAQ: ISRG) introduced at this time that it secured FDA 510(ok) clearance for its next-generation da Vinci 5 multiport surgical robotics system. 

The information comes lower than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the identify of the brand new system within the course of. (Here is our roundup of prime surgical robotics corporations.)

Da Vinci joins a deep portfolio of options from Intuitive

The da Vinci 5 joins Intuitive’s current da Vinci robotic surgical system portfolio alongside the multiport X and Xi programs and the single-port SP. There can also be Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy within the lung.

“We are pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5,” CEO Gary Guthart stated in a information launch after the market closed.

“Intuitive is committed to meaningful improvements in surgery that enable better patient outcomes, enhance the patient and care team experiences, and ultimately lower the total cost of care,” he continued. “After more than a decade of careful research, design, development, and testing, we believe da Vinci 5 will deliver on these goals and help drive the future of robotic-assisted surgery.”

Da Vinci 5 options:

Intuitive shared extra particulars about how the da Vinci 5 improves on earlier da Vinci robots.

Intuitive Surgical da Vinci 5 tower.

The Intuitive Surgical da Vinci 5 tower [Image courtesy of Intuitive Surgical]

  • The firm says new surgeon controllers and highly effective vibration and tremor controls make the da Vinci 5 the smoothest and most exact system it has developed so far;
  • Intuitive says the da Vinci 5 has a next-generation 3D show and picture processing, offering a high-quality and pure imaging expertise. The purpose is to allow surgeons to see extra at this time and assist future generations of surgical endoscopes and imaginative and prescient software program.
  • Da Vinci 5 introduces Force Feedback expertise and non-obligatory devices that allow the system to measure and surgeons to really feel refined forces exerted on tissue throughout surgical procedure. Intuitive says this characteristic is one thing no different surgical expertise in any modality presently presents. Intuitive says preclinical trials confirmed surgical procedures with Force Feedback demonstrated as much as 43% much less pressure exerted on tissue, which might end in much less trauma on tissue.
  • In addition to doubtlessly much less tissue trauma, Force Feedback will add an essential new knowledge stream to surgical knowledge science, in accordance with Intuitive. (Note: The Force Feedback devices are non-obligatory to be used with da Vinci; they cleared for lots of the identical procedures as da Vinci Xi.)
Intuitive Surgical da Vinci 5 insufflator.

The Intuitive Surgical da Vinci 5 insufflator [Image courtesy of Intuitive Surgical]

  • Da Vinci 5 additionally has options to assist improve surgeon autonomy and streamline surgeon and care staff workflow, boosting healthcare effectivity. ​For instance, da Vinci 5 has built-in key OR applied sciences, together with insufflation and an electrosurgical unit. There can also be an optimized person interface, with settings which can be accessible by the broader surgical staff and by the surgeon instantly from the head-in menu. Plus, surgeons can entry different key settings whereas head-in to assist them keep centered on the surgical subject.

  • Da Vinci 5 has greater than 10,000 instances the computing energy of da Vinci Xi. Intuitive says the vastly boosted computing energy permits progressive new system capabilities and superior digital experiences — now and sooner or later. There is integration with Intuitive’s My Intuitive app, SimNow (digital actuality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
  • Features to extend surgeon consolation embrace a redesigned console able to customizable positioning, permitting surgeons to seek out their greatest match for surgical viewing and luxury. Surgeons even have the flexibility to sit down utterly upright. The surgeon could make any vital changes whereas their head is within the console. In addition, there are alternatives designed to suit completely different physique sorts, together with surgeons who’re pregnant.
Intuitive Surgical da Vinci 5’s surgeon console.

The Intuitive Surgical da Vinci 5’s surgeon console [Image courtesy of Intuitive Surgical]

Limited availability for preliminary launch

Da Vinci 5 will initially be out there to a small variety of prospects within the U.S. who collaborated with Intuitive in the course of the growth interval and people with mature robotic surgical procedure applications. The firm’s purpose is to work with surgeons at these preliminary websites to generate extra knowledge on the system’s use earlier than a wider business introduction.

“We strive to provide customers with technology that meets their needs and solves important problems,” stated Intuitive Chief Medical Officer Dr. Myriam Curet. “We intend to launch da Vinci 5 more broadly in the U.S. and globally after we learn from and work with an initial smaller number of customers directly.”

Curet mentioned the key behind Intuitive’s surgical robotics success final 12 months with our sibling web site Medical Design & Outsourcing.

For an inside have a look at what the Da Vinci 5 is able to, register now to attend DeviceTalks Boston. Intuitive EVP and Chief Digital Officer Brian Miller will evaluation among the futuristic performance of the brand new system in a closing keynote, “Intuitive: The Future is Now with da Vinci 5.”


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