FDA clears Intuitive, Siemens Healthineers imaging integration for robotic bronchoscopy

[Image from Intuitive]Intuitive (Nasdaq:ISRG) announced that the FDA cleared an integration of imaging technology with the Ion robot-assisted bronchoscopy system.

The integration covers a mobile cone-beam CT (CBCT) imaging technology, developed by Siemens Healthineers, called Cios Spin.

Cios Spin offers integrated functionality with Ion to provide 2D and 3D imaging during procedures to help physicians gain confidence around refining Ion’s catheter positioning and help improve biopsy tool placement, according to a news release.

Sunnyvale, California-based Intuitive said early studies demonstrate that Ion enables a diagnostic yield of approximately 80% in studies with a relatively small average nodule size. The integration of Ion with Siemens’ imaging technology could improve the accuracy of biopsy procedures, aiding in the diagnosis of lung cancer, the company said, through the enhancement of a physician’s ability to provide minimally invas…

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Creo Medical inks collaboration agreement with Intuitive

Creo Medical Group (LON: CREO) announced today that it has signed a multi-year collaboration agreement with Intuitive to make certain Creo surgical technologies compatible with the surgical robotic giant’s systems.

The London exchange reacted by sending CREO shares up more than 4% to 100 pence apiece by the close of trading today. As of midday in New York, ISGR shares are up slightly to $221 apiece on the Nasdaq.

Based in the U.K., Creo is developing and commercializing a suite of electrosurgical medical devices. Its patented Kamaptive technology combines adaptive bipolar radiofrequency (RF) and super high-frequency microwave energy in the CROMA advanced energy platform. Kamaptive can dynamically adapt to patient tissue during procedures such as resection, dissection, coagulation and ablation of tissue, according to Creo.

Get the full story on our sister site Medical Design & Outsourcing. 

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Thanks, mom! Medtech leaders reflect on Mother’s Day

[Photo from Aditya Romansa on Unsplash]Everyone has a story about how they got into medtech, and it’s no surprise that many of those stories start with how we were raised.

As Mother’s Day approaches, Medical Design & Outsourcing asked medtech leaders to share some thoughts about how their moms inspired their careers, the products they make and the companies they’ve built.

We can never say “thanks” often enough to truly show our gratitude – but one more time can’t hurt.

Get the full story at our sister site, Medical Design & Outsourcing.

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Manufacturing matchmaker Fictiv raises $100M for supply chain push

Fictiv co-founder and CEO Dave Evans [Photo courtesy of Fictiv]Fictiv has closed a $100 million Series E funding round, the on-demand manufacturing technology company said today.

Fictiv focuses on “helping companies produce better products,” co-founder and CEO Dave Evans said, with three main offerings: new product development, engineer-to-order products, and maintenance, repair and operations (MRO).

But the company doesn’t actually own any manufacturing equipment, and instead has built a vetted network of 250 manufacturing partners, Evans told DeviceTalks Editorial Director Tom Salemi in an interview. After medical device developers upload their designs to Fictiv’s web-based platform, they get instant pricing and help choosing from different manufacturing methods, standards and prices to find the best fit.

Get the full story at our sister site, Medical Design & Outsourcing.

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Intuitive eyes sole-source suppliers as it expands capacity

Intuitive Surgical CFO Jamie Samath [Photo courtesy of Intuitive Surgical]Top executives at Intuitive Surgical (Nasdaq: ISRG) have sole-source suppliers on their minds as they ramp up manufacturing capacity in the face of continued supply chain challenges.

The robotic surgery technology developer’s growth and mindfulness of supply chain resiliency could bring new opportunities for Intuitive’s suppliers — along with competition from others who want in.

Sunnyvale, California–based Intuitive had just more than 10,500 employees at the end of March, CFO Jamie Samath said today on a conference call to discuss Intuitive’s first-quarter financial and operating performance. That employee count is up 26% from the same time a year before, and of the 2,100 new employees, he said about 900 work in manufacturing.

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Intuitive shares dip as first-quarter profits fall short

Intuitive (Nasdaq: ISRG) posted first-quarter financial results that fell short of the consensus forecast on Wall Street for earnings, but exceeded analysts’ expectations for sales.

The Sunnyvale, California–based robotic surgery technology developer reported profits of $366 million, or $1.02 per diluted share, on sales of $1.49 billion for the three months ended March 31, 2022. Compared with Q1 2021, that was a 14% decrease in the bottom line and 15% growth in sales.

Adjusted earnings per share were $1.00, 8¢ short of Wall Street, where analysts were looking for EPS of $1.08 on sales of $1.43 billion. Intuitive noted that it retroactively adjusted prior year EPS information to reflect a three-for-one stock split.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the first quarter of 2021. The COVID-19 pandemic continued to hold back procedures and supply chain disruptions continued, the…

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Intuitive posts Street-beating Q4 despite COVID-19-related procedure disruptions

Intuitive (Nasdaq: ISRG) shares slid in pre-market trading today despite fourth-quarter results that topped the consensus forecast.

The Sunnyvale, California-based robotic surgery technology developer posted profits of $380.6 million, or $1.04 per share, on sales of $1.6 billion for the three months ended Dec. 31, 2021, narrowly increasing its bottom line by about $100,000 on sales growth of 10.5% year-over-year.

Adjusted to exclude one-time items, earnings per share were $1.30, 2¢ ahead of Wall Street, while sales beat analysts’ projections by approximately 0.8%.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the fourth quarter of 2020, as last year was adversely affected by the COVID-19 pandemic. Intuitive said in a news release that the resurgence of COVID-19 late in the fourth quarter of 2021 also impacted procedures, though.

Intuitive did not provide financial guidan…

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Employees say Intuitive, Boston Scientific, J&J, Medtronic best places to work in 2022

Intuitive Surgical, Boston Scientific, Johnson & Johnson and Medtronic were recently named as Glassdoor’s employees’ choice of Best Places to Work in 2022.

Each year, Glassdoor uses feedback that employees have shared on the website over the past year to compile a list of the best places to work for the upcoming year. Employee reviews provide Glassdoor with insights into job and workplace attributes and qualitative feedback about why their employer provides the best place to work and what needs improvement.

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Intuitive reaches 10 million mark for da Vinci procedures peformed

Intuitive (Nasdaq: ISRG) recently announced that it has surpassed 10 million robotic-assisted surgical procedures performed on its da Vinci systems. 

The milestone is another reminder of the leadership position Intuitive has carved out in the robotic surgery space since the first FDA clearance for a da Vinci system in 2000.

“Surgeon use of da Vinci surgical systems in more than 10 million procedures reflects the benefits that high-quality, minimally invasive surgery conveys to patients, families and the healthcare systems that care for them,” Intuitive CEO Gary Guthart said in a December 14 news release.

Guthart, however, wasn’t letting Intuitive sit on its laurels.

“While we are proud of this milestone and momentum, this is really a moment to look at what we’ve learned from these 10 million procedures and ask ourselves how we can apply that to improving the field of surgery for years to come,” Guthart said. 

Intuitive presently…

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Intuitive wins FDA clearance for robotic stapler

Intuitive (NSDQ:ISRG) announced today that it received FDA clearance for its SureForm stapler and reloads for use in surgery.

Sunnyvale, California-based Intuitive designed its fully wristed, 8 mm SureForm 30 curved-tip stapler and reloads (gray, white and blue) for use in general, thoracic, gynecologic, urologic and pediatric surgery.

Its aim is to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation and the curved tip. As the stapler fits through the 8 mm da Vinci surgical robot instrument cannula, it allows different angles for surgeons to approach patient anatomy.

The 8mm SureForm 30 curved-tip stapler also integrates SmartFire software for optimizing staple line performance by measuring tissue compression before and during stapling.

According to a news release, the company expects to launch the 8 mm SureForm 30 stapler in the U.S. in 2022…

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Intuitive responds to FDA alert on robot-assisted mastectomies

The FDA is warning patients and health care providers that some clinical studies using robotically-assisted surgical devices for mastectomies may not have the proper regulatory supervision.

The FDA said it is “aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.”

The agency has cleared robotically-assisted surgical devices for use in hysterectomies, prostatectomies and colectomy based on 30-day follow-ups with patients, but cautioned that it “has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”

Get the full story on our sister site Medical Design & Outsourcing. 

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Intuitive Surgical to invest $500M in Georgia campus

Intuitive Surgical (NASDAQ: ISRG) will spend more than $500 million to expand its Peachtree Corners campus northeast of Atlanta, according to Georgia Gov. Brian P. Kemp’s office.

The Sunnyvale, Calif.–based robotic surgery systems company — the dominant player in the space — has had a presence in Georgia for a decade. The plan is to expand the Peachtree Corners campus to 750,000 square feet of manufacturing and engineering operations, training facilities for surgeons and hospital care teams, and administrative offices.

The expansion will take place in phases, with completion in 2024. Intuitive plans to add 1,200 jobs on top of the 180 professionals it already has based in Peachtree Corners.

“Intuitive needs a highly educated, committed, and diverse workforce; quality infrastructure; and the right geography to meet the rising demand for minimally invasive surgical technologies,” Intuitive CEO Gary Guthart said in a news release out of Kemp’s o…

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