Intuitive secures FDA clearance for da Vinci 5 surgical robotic


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Intuitive surgical Da Vinci surgical system.

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

Intuitive Surgical (NASDAQ: ISRG) introduced as we speak that it secured FDA 510(okay) 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 title of the brand new system within the course of. (Right here is our roundup of high surgical robotics firms.)

Da Vinci joins a deep portfolio of options from Intuitive

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

“We’re happy to obtain FDA clearance for our fifth-generation robotic system, da Vinci 5,” CEO Gary Guthart mentioned in a information launch after the market closed.

“Intuitive is dedicated to significant enhancements in surgical procedure that allow higher affected person outcomes, improve the affected person and care staff experiences, and finally decrease the full value of care,” he continued. “After greater than a decade of cautious analysis, design, improvement, and testing, we consider da Vinci 5 will ship on these targets and assist drive the way forward for robotic-assisted surgical procedure.”

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 corporate 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 thus 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 as we speak and assist future generations of surgical endoscopes and imaginative and prescient software program.
  • Da Vinci 5 introduces Drive Suggestions expertise and elective 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 provides. Intuitive says preclinical trials confirmed surgical procedures with Drive Suggestions demonstrated as much as 43% much less pressure exerted on tissue, which may end in much less trauma on tissue.
  • Along with doubtlessly much less tissue trauma, Drive Suggestions will add an vital new information stream to surgical information science, in keeping with Intuitive. (Notice: The Drive Suggestions devices are elective 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 enhance 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 may be additionally an optimized consumer 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 occasions the computing energy of da Vinci Xi. Intuitive says the enormously boosted computing energy permits revolutionary new system capabilities and superior digital experiences — now and sooner or later. There may be integration with Intuitive’s My Intuitive app, SimNow (digital actuality simulator), Case Insights (computational observer), and Intuitive Hub (edge computing system).
  • Options to extend surgeon consolation embody a redesigned console able to customizable positioning, permitting surgeons to search out their finest match for surgical viewing and luxury. Surgeons even have the flexibility to take a seat fully upright. The surgeon could make any needed changes whereas their head is within the console. As well as, there are alternatives designed to suit totally 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]

Restricted availability for preliminary launch

Da Vinci 5 will initially be obtainable to a small variety of clients within the U.S. who collaborated with Intuitive through the improvement interval and people with mature robotic surgical procedure packages. The corporate’s purpose is to work with surgeons at these preliminary websites to generate extra information on the system’s use earlier than a wider industrial introduction.

“We try to supply clients with expertise that meets their wants and solves vital issues,” mentioned Intuitive Chief Medical Officer Dr. Myriam Curet. “We intend to launch da Vinci 5 extra broadly within the U.S. and globally after we study from and work with an preliminary smaller variety of clients instantly.”

Curet mentioned the key behind Intuitive’s surgical robotics success final yr with our sibling website Medical Design & Outsourcing.

For an inside take 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 overview a number of 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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