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Medtronic wins CE mark for next-gen Micra leadless pacemakers

The Micra AV2 and Micra VR2 leadless pacemakers. [Images courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its next-generation Micra AV2 and Micra VR2 miniature, leadless pacemakers.

CE mark follows FDA approval for both devices in May of last year.

The pacemakers — which Medtronic labels as the world’s smallest — provide longer battery life and easier programming than earlier versions. Micra AV2 and Micra VR2 offer approximately 40% more battery life than previous generations. Medtronic projects battery life of nearly 16 and 17 years, respectively, for the devices.

Still, they deliver the benefits of leadless pacing like reduced complications compared to traditional pacemakers, Medtronic says. According to a news release, more than 80% of patients who receive a Micra may only require one device for life.

Micra devices also offer remote monitoring capab…

AI basics from Medtronic Chief Technology and Innovation Officer Ken Washington

Medtronic SVP and Chief Technology and Innovation Officer Ken Washington [Photo courtesy of Medtronic]

Medtronic SVP and Chief Technology and Innovation Officer Ken Washington was recently briefing the 15 general managers who run each of the operating units at the world’s largest medical device manufacturer.

In the middle of the first chart in his presentation on artificial intelligence, one of the leaders stopped him.

As Washington tells it, they said, “I just don’t understand all these different buzzwords around AI. Can you tell me what are the different types of AI? How does it all work? And what’s the difference between generative AI and deep learning?”

Washington — who joined Medtronic in June 2023 after serving as VP and GM of consumer robotics at Amazon and CTO at Ford Motor Co. before that — pulled out an easel, grabbed a marker, and walked the group through t…

The 10 biggest diabetes tech stories from 2023

Medtronic, EOFlow, Dexcom, Beta Bionics and Tandem Diabetes Care all contributed some of the biggest diabetes technology stories of 2023.

It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part.

Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too.

In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no different. Big hitters like Dexcom, Abbott, Medtronic, Insulet and more all contributed to some of the biggest stories in 2023. External factors — like popular GLP-1 drugs and big tech names looking to enter the space — also made the cut.

Here are 10 of the most intriguing diabetes technology stories from the past 12 months.

Medtronic was set to buy EOFlow — until it wasn’t

The medtech giant made a big splash in the insulin delivery space when it announced its plan to buy South K…

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

Medtronic has a Class I recall for its surgical navigation software

The FDA deemed the recall of Medtronic (NYSE: MDT) + StealthStation S8 software Class I, the most serious kind.

This recall — a correction, not a product removal — relates to StealthStation S8 Application Version 2.0 and 2.0.1. It affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall on Sept. 27, 2023.

StealthStation is used for any medical condition in which the use of stereotactic surgery may be appropriate. It keeps track of surgical tools’ locations in relation to a patient’s anatomy by using images of the patient. The system shows the surgeon a tool’s location and the surgeon can plan the path for the tools and see how they should move.

During surgery, the software helps surgeons see if the tool position matches the plan, guiding them along the right path. The tools help find body parts during brain surgery, both open and less …

What’s so special about pulsed field ablation? Medtronic EVP Sean Salmon explains

The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]

Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System — which won the first FDA approval for PFA to treat atrial fibrillation (AFib) — is just the start of a wave of new PFA devices expected to hit the market.

Medtronic is lining up another PFA cardiac ablation system for approval, while competitor Boston Scientific anticipates approval of its Farapulse PFA system sometime in 2024. Meanwhile, Johnson & Johnson’s Biosense Webster is testing its ThermoCool SmartTouch SF system for both PFA and radiofrequency ablation.

Medtronic EVP and Cardiovascular President Sean Salmon recently discussed PFA technology in an interview with Medical Design & Outsourcing before the world’s largest medical device manufacturer anno…

Medtronic PulseSelect pulsed field ablation wins FDA approval

The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]The FDA has approved the Medtronic (NYSE: MDT) + PulseSelect Pulsed Field Ablation (PFA) System, the device developer said today.

PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.

The minimally invasive, cardiac ablation system is indicated for the treatment of paroxysmal and persistent atrial fibrillation (AFIb).

Medtronic said it will start commercialization in early 2024.

“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency,” Medtronic SVP and Cardiac Ablation Solutions President Rebecca Se…

Medtronic, Cosmo Pharma expand AI collab for GI Genius

Medtronic’s GI Genius intelligent endoscopy module [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it agreed to expand its partnership with Cosmo Intelligent Medical Devices.

The medtech giant aims to build upon already realized achievements with the Cosmo Pharmaceuticals subsidiary. Their AI-driven partnership centers around the GI Genius intelligent endoscopy module.

Through the exclusive, global partnership, Medtronic and Cosmo seek to revolutionize endoscopy by utilizing AI to improve patient outcomes. Medtronic said in a news release that the alliance reinforces its position in AI-integrated healthcare. The company also says it represents a “significant leap” in incorporating AI into endoscopic care.

Medtronic and Cosmo partnered on innovative and scalable AI platforms like the AI Access kit. AI Access hosts multiple third-party AI applications to allow for faster innovati…

Medtronic execs: renal denervation for AFib could be on the horizon

The Medtronic Symplicty Spyral renal denervation (RDN) catheter delivers radiofrequency energy from four electrodes to ablate nerves in the renal arteries and treat high blood pressure. The nitinol-based device expands in a spiral pattern inside the blood vessel. [Image courtesy of Medtronic]

Medtronic renal denervation leaders Jason Weidman and Sean Salmon discuss RDN’s potential to help patients with atrial fibrillation (AFib).

As if treating an epidemic-level condition like hypertension wasn’t enough, renal denervation (RDN) also shows potential for atrial fibrillation (AFib) and other conditions related to high blood pressure.

In interviews with Medical Design & Outsourcing, Medtronic EVP Sean Salmon and SVP Jason Wediman discussed whether their Spyral Symplicity radiofrequency (RF) catheter ablation technology could help AFib patients when paired with cryoablation.

Weidman — pres…

Report: There’s still ‘mutual interest’ with EOFlow, Medtronic despite deal falling through

Business Korea reports that EOFlow CEO Kim Jae-jin is leaving the door open with regard to the company’s collapsed deal with Medtronic (NYSE: MDT) + .

Medtronic announced this week that it terminated its $738 million agreement to acquire EOFlow, a maker of insulin patch pumps. The medtech giant cited “multiple breaches” of terms in the agreement as the reason behind the decision.

According to the Business Korea report, Jae-jin said the company itself terminated the acquisition contract with Medtronic.

He said both sides tried to find a mutual agreement over the past few weeks, citing “fundamental differences in perspective.” The CEO said Medtronic views ongoing legal disputes over IP with patch pump leader Insulet as “uncertain.”

Get the full story at our sister site, Drug Delivery Business News.

Medtronic nixes $738M deal for insulin patch pump maker EOFlow

[Image from the EOFlow website]Medtronic (NYSE: MDT) + filed a Form 8K with the SEC today stating that it terminated its agreement to buy EOFlow.

The medtech giant struck a $738 million deal to acquire the Seongnam, South Korea-based insulin patch pump maker in May. EOFlow develops the EOPatch — a tubeless, wearable and fully disposable insulin delivery device.

Medtronic’s SEC filing stated that, based upon “multiple breaches,” the company notified EOFlow of its decision to terminate the deal. The company said it believes no termination fee is payable under the agreement and the termination doesn’t impact its fiscal 2024 guidance.

EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device for U.S. FDA clearance in January.

Medtronic’s plans to buy EOFlow looked set to pit the company against leading patch pump mak…

Medtronic wins CE mark for rechargeable deep brain stimulation tech

The Percept RC device. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced that it received CE mark approval for its Percept RC neurostimulation device.

The medtech giant labeled the deep brain stimulation (DBS) device as the smallest and thinnest device on the market. Also rechargeable, the system features BrainSense sensing technology. Medtronic says its launch marks the first release of a rechargeable DBS system with this sensing technology in Europe.

BrainSense technology enables physicians to track patient brain signals and correlate them with patient-recorded events. These include symptoms or side effects associated with diseases such as Parkinson’s disease. Physicians can also correlate to medications, tailoring therapy to a patient’s evolving needs.

“This development represents a critical step in our journey to transform brain modulation through sensing-enabled DBS,” said Amaza …