Intuitive Surgical Archives - Medical Design Sourcing

Intuitive Ion wins regulatory approval in China

The Intuitive Ion system [Image from Intuitive]Intuitive Surgical (NASDAQ: ISRG) + has received approval from regulatory authorities in China to market its Ion surgical robot system.

BTIG analyst Ryan Zimmerman said today that the National Medical Products Administration in China approved the system. This occurred through Intuitive’s partnership with Shanghai Fosun Pharmaceutical, a venture established in 2016.

The major regulatory nod in China follows last week’s FDA approval for the company’s next-generation da Vinci 5 surgical robot.

Intuitive Fosun now produces most of the biopsy needles used in the Ion system and has capacity for about 70% of the global demand, Zimmerman says. Zimmerman and BTIG’s Iseult McMahon said in their report that they expect Intuitive to “ramp up Ion production and sales in China rapidly as a result.”

The analysts said that, along with regulat…

After Intuitive, Shockwave and Avail, Daniel Hawkins is now CEO at AI-powered MRI software startup Vista.ai

Former Avail Medsystems CEO Daniel Hawkins is now president and CEO of Vista.ai. [Photo courtesy of Avail Medsystems]Avail Medsystems founder and former CEO Daniel Hawkins has a new job as president and CEO of MRI software startup Vista.ai.

Palo Alto, California-based Vista.ai (founded and incorporated as HeartVista) makes AI-guided software for automating magnetic resonance imaging (MRI) exams.

Vista.ai was founded by Chief Medical Officer Bob Hu, Chief Architect and Head of Research Juan Santos and Chief Technology Officer William Overall. Its advisory board includes Stanford University doctors and professors and the radiology chair at the University of Wisconsin–Madison.

The company won FDA 510(k) clearances for its HeartVista Workstation with RTHawk application software for the acquisition of real-time and accelerated images from GE Healthcare whole-body MRI systems in 2014, 2017 and 2017. In 2019, the FDA cleared the company’s AI-assisted One Cli…

Intuitive details da Vinci 5 launch plans with limited supply of next-gen surgical robotics systems

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + is planning a phased launch of its da Vinci 5 that will stretch into next year, executives said today.

Intuitive won FDA 510(k) clearance for its next-generation surgical robotics system last week, nearly one decade after winning clearance for the da Vinci Xi system.

“We are planning for a limited launch starting in the U.S. as we optimize manufacturing and supply chains, and progressively expand our manufacturing capacity,” CFO Jamie Samath said. “We expect to be in this limited launch phase into 2025. During this period, we will be focused on customers that collaborated with us during the development period and those customers who have mature robotic programs and have a need to expand capacity.”

Others who…

Intuitive wins FDA clearance for its next-gen da Vinci 5

Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (NASDAQ: ISRG) + announced today that it secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system.

The news comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here is our roundup of top surgical robotics companies.)

The da Vinci 5 joins 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 pleased to receive FDA clearance for our fifth-generation robotic system, da Vinci 5…

How GLP-1s tanked and reshaped the medtech stock market in 2023

Analysts weigh in on how the GLP-1 craze caused one of the biggest swings in the medtech stock market in recent years.

[Image courtesy of Nick Chong on Unsplash]In a tumultuous year for the medtech industry, promising clinical trial results on glucagon-like peptide 1 agonists (GLP-1s) created a seismic shift in the medtech stock market, triggering one of the largest dips in market value that analysts have seen in years.

While analysts said the medtech stock market performed well in 2023 – driven by strong market growth from the backlog of procedures that built up during the pandemic and more innovation and new product launches from companies – the fear of GLP-1s prevailed among investors, sending medtech stocks down significantly in the second half of the year, even as top executives sought to allay concerns.

The specter of GLP-1s such as Novo Nordisk’s Wegovy and Ozempic loomed large, casting doubt on medtech’s future trajectory at the end of the year. However, the stocks have almost fully recovered since then. Analysts predict a rebound in 2024, with diminishing head…

10 surgical robotics companies you need to know

The surgical robotics space saw a major shakeup last year. The da Vinci SP surgical robotics system [Image courtesy of Intuitive Surgical]“Robotics is hard. Robotics in healthcare is hard.”

Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October.

It pretty much sums up the situation for medtech companies large and small that sought to compete against Intuitive in the soft-tissue surgical robotics space. Despite the increased competition, Intuitive remains the undisputed leader. It’s even moving forward on a next-gen da Vinci robot.

For its part, Johnson & Johnson is sticking with plans to develop its Ottava surgical robot. J&J now plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 in order to start clinical trials.

Even though it is sticking with robotic surgery, J&J laid off employees in th…

Intuitive wins CE mark for da Vinci SP surgical robot

The da Vinci SP surgical robot system. [Image courtesy of Intuitive Surgical]Intuitive Surgical (Nasdaq: ISRG) + announced today that it received CE mark approval for its da Vinci SP surgical robot platform.

da Vinci SP, the company’s single-port system, joins the existing X and Xi surgical ecosystem in Europe. Beginning in urology and transoral procedures, European clinicians can grow into additional applications over time. This follows last night’s news — within Intuitive’s fourth-quarter earnings — that the company submitted its next-generation da Vinci 5 multiport surgical robot to the FDA for clearance.

Intuitive said da Vinci SP gives surgeons the ability to deliver robotic-assisted surgery through a single port. It potentially opens the door to “the next era of surgical innovation.”

da Vinci SP features three multi-jointed, wristed instruments and a fully wristed 3D high-defini…

Intuitive seeks FDA clearance for its next-gen da Vinci 5

Intuitive Surgical (NYSE: ISRG) + stock is up after hours on news 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 th…

Inspire Medical adds Intuitive CMO Dr. Myriam Curet to its board

Intuitive Surgical Chief Medical Officer Dr. Myriam Curet [Photo courtesy of Intuitive Surgical]Inspire Medical Systems (NYSE:INSP) announced today that it appointed Dr. Myriam J. Curet as an independent board director.

Curet’s appointment went into effect on Dec. 21, 2023. She currently serves as EVP and chief medical officer at surgical robotics pioneer Intuitive Surgical. Curet spoke to Medical Design & Outsourcing this year to explain the secret behind Intuitive’s surgical robotics success.

“We are excited to add Dr. Curet, a practicing, board-certified minimally invasive general surgeon with extensive business and executive leadership experience in the medical device industry to our board of directors,” said Tim Herbert, president and CEO of Inspire Medical Systems. “Dr. Curet brings significant experience in developing and commercializing scalable solutions for minimally invasive surgery and we look forward to her guidance, expertise and cont…

Intuitive Ventures brings in $150M to support minimally invasive care startups

Intuitive Ventures announced today that it closed a $150 million funding round to support early-stage minimally invasive care companies.

Surgical robotics pioneer Intuitive Surgical launched Intuitive Ventures with $100 million in funding more than three years ago. The early-stage fund earmarked its latest round of funding, labeled “Fund II,” for three areas of investment focus. It wants to support improved access and coordination, precision diagnostics and interventions and secure, enriched digital ecosystems.

Intuitive Ventures said in a news release that it aims to lower the barriers to care with efficient, cost-effective, accessible care. By leveraging the intersection of medtech, life sciences and therapeutics, it believes it can support diagnostics and interventions, too. The fund also hopes to utilize the potential of novel healthcare data to enhance minimally invasive care.

“We are proud of the strides achieved by the Ventures team ov…

Intuitive appoints Align Technology exec to its board

New Intuitive board member Sreelakshmi Kolli. [Image from Zimmer Biomet]Intuitive (Nasdaq: ISRG) + announced that it appointed Align Technology executive Sreelakshmi Kolli to its board of directors.

Kolli currently serves as EVP and chief digital officer at Align, the maker of Invisalign clear aligners and other dental tech. Her appointment to Intuitive’s board of directors went into effect on Oct. 27, 2023.

“Sree has deep expertise in applying technology to transform industries, enable business growth and drive strategy,” said Intuitive CEO Gary Guthart. “We look forward to her insights, particularly with respect to digital capabilities and meaningful customer experiences, as we continue to advance what’s possible in minimally invasive care.”

Kolli’s current role at Align holds responsibility for leading software, data, enterprise, cloud and infrastructure engineering. Her focus centers around the desi…

Intuitive leaders weigh in on GLP-1 drugs and surgical robotics procedures

Intuitive Surgical Chief Medical Officer Dr. Myriam Curet [Photo courtesy of Intuitive Surgical]Intuitive Surgical (Nasdaq: ISRG) + executives say they see benefits to their business from GLP-1 weight loss drugs, even if investors aren’t quite so sure.

Intuitive’s stock slid in after-hours trading today after the company posted Q3 results that exceeded analysts’ expectations on profits but fell short on sales. Even if they had beat The Street on both counts, it’s not clear investors would have reacted any differently — just look at what happened to Intuitive’s stock price under that exact scenario after Q2.

In Q2, the company said bariatric procedure growth slowed due to patient interest in weight loss drugs.

Related: Analysts expect minor GLP-1 impact on insulin pumps, but a boost for CGMs

“Bariatric procedures represent between four and 5% of total global procedures,R…