Intuitive seeks FDA clearance for next-gen da Vinci 5 surgical robot

-

Intuitive Surgical said today that it has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are submitted and in the back-and-forth with the FDA. It is our hope for a 2024 launch, but they are ultimately the arbiters of when we get clearance,” CEO Gary Guthart said during an evening earnings call with analysts.

ISGR shares were up more than 6% to $395 apiece on the news.

News of Intuitive moving forward with a next-generation da Vinci system has been much anticipated. Intuitive officials had previously stayed quiet on the timing, especially after the company’s stock took a temporary hit a year ago when Guthart mentioned there would not be a new multiport system launch in 2023.

Guthart said Intuitive has completed a comprehensive multicenter IDE trial for the da Vinci 5. The trial finished accruing patients in May 2023, with Intuitive submitting for 510(k) clearance in August 2023. The company is responding to the FDA’s questions, which Guthart described as falling within normal expectations.

In addition, Intuitive has initiated conversations about da Vinci 5 with regulators in Japan and South Korea, according to Guthart.

Intuitive Surgical CFO Jamie Samath outlined how Intuitive is gearing up for da Vinci 5 manufacturing. The company has already transferred X system production to its East Coast hub near Atlanta. This year, Xi system production will move to Atlanta, too.

SITE AD for the 2024 Robotics Summit registration.Register now for the 2024 Robotics Summit.

Over the next 18 months, the company will open new manufacturing facilities in California for the da Vinci 5 and Ion, he said. It will also complete line transfers for Ion and SP to Mexicali, Mexico.

“We believe these activities will position Intuitive to serve our customers with best-in-class supply availability, product quality and product cost,” Samath said.

Guthart and other Intuitive officials promised more details about the da Vinci 5’s features and benefits after the company receives FDA clearance.

“We think that having a portfolio of choices makes a ton of sense for hospitals, and this will be a part of that portfolio,” Guthart said.

Robotic Surgery Market Grows Rapidly in Response to Disease, Technology

Intuitive’s da Vinci X surgical robotic system. Credit: Intuitive Surgical

Intuitive had a Street-beating Q4

On top of the da Vinci 5 news, Intuitive reported fourth-quarter 2023 results that exceeded the consensus of Wall Street analysts. Revenue was up 17% year-over-year to $1.93 billion. Net income was $606 million, or $1.69 per share, compared with $325 million, or 91¢ per share, in Q4 2022.

Adjusted to exclude one-time items, Intuitive’s EPS was $1.60. The result was 12¢ ahead of The Street, where analysts expected EPS of $1.48 and revenue of $1.89 billion.

Worldwide da Vinci procedures grew roughly 21% compared with the fourth quarter of 2022, and the install base was up 14% — to 8,606 systems — from a year ago.

Editor’s Note: This article was republished from sister website MassDevice.

The post Intuitive seeks FDA clearance for next-gen da Vinci 5 surgical robot appeared first on The Robot Report.



from The Robot Report - Robotics News, Analysis & Research https://ift.tt/Dm0OihF
via artificialconference

Comments

Post a Comment

Popular posts from this blog

Chipotle testing avocado processing robot in test kitchen

-
Image
Chipotle Mexican Grill announced Autocado, an avocado processing cobotic prototype that cuts, cores, and peels avocados before they are hand mashed to create the restaurant’s famous guacamole. The prototype, developed in collaboration with Vebu , is currently being tested at the Chipotle Cultivate Center in Irvine , California.  How Autocado works  A team member loads Autocado with a full case of ripe avocados and selects the size setting. Autocado can hold up to 25 lbs. of avocados at once. One at a time, avocados are vertically oriented, then transferred to the processing device. The avocados are sliced in half. Their cores and skin are automatically removed, and the waste is discarded.  The fruit is safely collected in a stainless-steel bowl at the bottom of the device.  A team member removes the bowl of avocado fruit and moves it to the counter where they add additional ingredients and hand mash the avocados to make Chipotle’s signature guacamole.  How the Autocado idea s
Read more

Inside Comaus testing of Intrinsic Flowstate

-
Image
Intrinsic tested its latest platform and Flowstate with Comau , an Italian-based robot manufacturer and global systems integrator. Comau has been working with Intrinsic for several years now to validate Intrinsic’s platform technology and developer product, Flowstate, through real-world use cases.  Flowstate, announced earlier this year in May , is a robotic software development platform. It’s Intrinsic’s first developer product built on the Intrinsic platform. Comau was also introduced as the company’s first industry partner in May.  The Intrinsic Flowstate software  adds a layer of abstraction to traditional robotic software tools with the goal of reducing the development skillset required while making it easier than ever before to program a robot in simulation. “Partnering with Comau over the years has brought our team a tremendous amount of expertise, knowledge, and real-world use cases to focus our efforts on. We’re excited for what’s next and what it will mean to the solutio
Read more

ABB launches Flexley mobile robots, completing rebranding of ASTI AMRs

-
Image
Rebranded ABB Flexley autonomous mobile robots (AMRs) completes the integration of ASTI into ABB Robotics business. | Credit: ABB ABB launched its first range of rebranded Autonomous Mobile Robots (AMRs) following its acquisition of mobile robot leader ASTI Mobile Robotics in 2021 for $190M . ASTI Mobile Robotics’ solutions are now rebranded and integrated into ABB’s portfolio, grouped under the Flexley name, indicating the flexibility of operations that the AMRs offer. The first rebranded models to be released, Flexley Tug and Flexley Mover, cover applications including towing, trolley transportation up to 5,350 lbs (2000 kg), as well as lifting and transporting racks, containers and pallets of 4,000 lbs (1,500 kg). The ABB Flexley Mover (l) and ABB Flexley Tug (r) become the first rebranded ABB AMRs to be released. | Credit: ABB ABB joins OMRON corporation as the second automation solutions company to offer a complete lineup of autonomous mobile robots (AMRs), industrial robo
Read more