January 2024 edition: The Leadership in Medtech issue



 

Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

How Recor Medical won the renal denervation race for FDA approval

Medtech’s biggest personnel moves of 2023

Leadership and innovation in medtech

Creativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN).

You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor.

Our annual Leadership in Medtech issue of Medical Design &a…

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How exposed are Medtronic, Intuitive and other Medtech Big 100 device makers to China?

China promises risk and upside for Medtronic, Intuitive and other major medical device manufacturers. [Photo via Adobe Stock]

As economic concerns shift from the U.S. to China, medical device manufacturers such as Medtronic and Intuitive are monitoring how procedure volumes and new policies affect their businesses.

In a new note, William Blair analyst Brandon Vazquez details the exposure of those companies and four more on Medical Design & Outsourcing‘s Medtech Big 100 ranking of the world’s largest device makers.

“The bottom line for our coverage universe is that exposure seems manageable with all companies at 10% or less of revenues/procedures coming from China, though we admit materially worsening macro conditions, if materialized, have the potential to move the needle on results — something we have already heard from some intra-quarter updates this month,” Vazquez wrote. Read more

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How Noah Medical’s robotic Galaxy system goes deep into the lungs

Noah Medical’s Galaxy system for lung biopsy uses a robotic bronchoscope to reach and sample for suspected cancers deep in a patient’s lungs.

But the brightest star in the Galaxy system isn’t that disposable, robotic scope, but rather Noah Medical’s tool-in-lesion tomosynthesis (TiLT) technology, designed to help surgeons retrieve samples that will provide a definitive answer from the pathology lab.

Medical Design & Outsourcing spoke with Noah Medical VP of Engineering John Shen to learn more about how the system works, how it was developed, and potential applications of the technology.

Noah Medical VP of Engineering John Shen [Photo courtesy of Noah Medical]

“Robotic systems are hellishly complex,” Shen said. “There are many, many, many systems or components that in their own right are complex devices, and they all need to be working together …
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Two technologies that will be huge for robotic surgery, per Intuitive’s Dave Rosa

Intuitive President Dave Rosa [Photo courtesy of Intuitive]

Intuitive Surgical President Dave Rosa says he doesn’t get too excited by the idea of better robotic surgery graspers or more flexible wrists.

Instead, Rosa identified two technological opportunities that are going to advance surgical robotics and minimally invasive surgery in a major way: improved visualization for surgeons and focal therapy.

“How can we help surgeons see more about what they’re doing? … That, to me, is a huge piece of the puzzle going forward that I’m really excited about,” Rosa said in an interview with DeviceTalks Editorial Director Tom Salemi for our Intuitive Talks podcast.

DeviceTalks West: Intuitive President Dave Rosa will give a keynote interview in Santa Clara, California on Oct. 19 

Improving visualization

The difference between the best and worst surgeons isn’t…

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Find solutions to your most demanding medtech problem at DeviceTalks West

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

Intuitive President Dave Rosa will give a keynote interview at DeviceTalks West 2023. [Photo courtesy of Intuitive]

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our…

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Join us at DeviceTalks West, the World’s Fair of Medtech

Intuitive Surgical CEO Gary Guthart will participate in a keynote interview at DeviceTalks West 2022. [Photo courtesy of Intuitive Surgical]

October’s DeviceTalks West conference is focused on the future.

The best-seller “Devil in the White City” may have darkened the perception of world’s fairs, but these international convocations have long presented visitors with an optimistic and hopeful view of the future, thanks in no small part to new technology. (The next one is scheduled for 2025 in Osaka, Japan, by the way.)

I like to think we’ll be following similar guidelines at the upcoming DeviceTalks West conference, which will be held on Oct. 19-20 at the Santa Clara Convention Center.

This event will bring together executives from Abbott, Boston Scientific, Edwards Lifesciences, Intuitive, Johnson & Johnson, Medtronic, Outset Medical, Penumbra, Shockwave, Zimmer Biomet and many …

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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.

The agreement with Intuitives outlines how the companies will conduct joint clinical studies and includes a number of milestone …

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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.”

The FDA did not name specific device manufacturers, but its Aug. 20 safety communication came about a month after the publication of a MedScape report hig…

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