Medtronic Archives - Page 13 of 59 - Medical Design Sourcing

Health Canada licenses Medtronic Guardian 4 CGM sensor for use with MiniMed 780G

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced that it received a license from Health Canada for use of its Guardian 4 with the MiniMed 780G.

The licensing enables the use of the next-generation continuous glucose monitor sensor with the next-generation automated insulin pump. MiniMed 780G with Guardian 4, an advanced, hybrid closed-loop system, helps users manage type 1 diabetes.

Health Canada licensing comes on the heels of FDA approval for the MiniMed 780G with Guardian 4. The system requires no fingersticks while in SmartGuard mode. It offers meal detection technology, providing automatic adjustments and corrections to sugar levels every five minutes.

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

Medtronic wins FDA nod for next-gen Micra leadless pacemaker

The Micra AV — compared to a dime here — comes in around the size of a multivitamin. [Image from Medtronic]Medtronic (NYSE: MDT) + announced today that it received FDA approval for its Micra AV2 and Micra VR2 leadless pacemakers.

The next-generation, miniaturized, leadless pacemakers offer longer battery life and easier programming compared to previous versions. Medtronic said they also continue to deliver the established benefits of leadless pacing, such as reduced complications compared to traditional pacemakers.

According to a news release, Medtronic Micra AV2 and VR2 bring 40% more battery life compared to previous generations. The devices have a median projected battery life of nearly 16 years (AV2) and 17 years (VR2). Medtronic said this means more than 80% of patients receiving a Micra pacemaker should only need one device for life.

The Micra AV2 also features advanced algorithms that automatically program A…

10-year data shows durable outcomes with Medtronic Endurant stent graft system

The Endurant stent graft system. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced positive results from its 10-year post-market registry for the Endurant stent graft.

The Endurant stent graft system offers Endovascular aneurysm repair (EVAR) to treat patients with abdominal aortic aneurysm (AAA). Medtronic posted the real-world data at the 2023 Charing Cross Symposium in London, marking the completion of the study.

Dr. Hence Verhagen, ENGAGE investigator, called the data “strong and robust evidence” demonstrating long-term durable outcomes. Verhagen serves as chief of vascular surgery at Erasmus University Medical Center in Rotterdam, The Netherlands. He also presented the data in London.

The ENGAGE registry evaluated more than 1,200 patients. Ten-year data included follow-up from approximately 400 of these patients and showed a 94.7% freedom from aneurysm-related mortality. It also demonstrated a 64.1% sac regression (or decrea…

MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market.

For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone,

The company hit an initial hiccup with an FDA warning letter related to its California Diabetes facility in 2021. CEO Geoff Martha said early in 2022 that the letter was likely to impact the regulatory timelines for next-generation technology. Meanwhile, analysts were suggesting that the unit was on the spinoff block.

For now, those issues are in the past, though. Medtronic yesterday said it fully resolved the warning letter with the FDA.

Just a few days earlier, Medtronic announced that it received FDA approval for MiniMed 780G with Guardian 4.

The system offers meal detection technology and provides automatic adjustment…

Medtronic Diabetes unit fully resolves FDA warning letter

Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters.

In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters.

The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of risk assessment, corrective and preventive action and complaint handling. The letter also related to device recalls and the reporting of adverse events.

Medtronic said today that the resolution follows ongoing remediation from the company. It took proactive actions to continue to strengthen its quality systems, according to a news release. All regulatory restrictions associated with the letter are resolved, the company said.

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

AI breakthroughs in medtech: 7 ways to enhance healthcare

[Image from Pixabay]

Whether it’s OpenAI’s ChatGPT, Microsoft’s new Bing or Google’s Bard, 2023 is the year when generative artificial intelligence entered the popular consciousness.

In the medtech space, it seems as though every company is seeking ways to incorporate some form of AI into the digital features of their products and services.

So what is artificial intelligence good at so far when it comes to advancing medtech and healthcare in general? Here are seven recent examples:

1. Helping physicians identify medical problems quickly

GI Genius’ AI-based enhancements place green boxes around areas that may need extra scrutiny during a colonoscopy, helping to prevent physicians from losing their focus. [Image courtesy of Medtronic]

Interest is growing in artificial intelligence that can help radiologists, gastroenterologists and othe…

Medtronic prices $2 billion of senior notes

Medtronic (NYSE:MDT) announced that its Medtronic Global Holdings S.C.A subsidiary priced an offering of senior notes worth $2 billion.

The financial move comes at the same time that the world’s largest medical device company engages in significant expense reductions. The idea is to boost the company’s resilience against the present macroeconomic headwinds.

The wholly-owned subsidiary — Medtronic Luxco — priced the offering of two different groups of senior notes. The first, with a principal amount of $1 million, includes 4.25% senior notes due in 2028. Medtronic Luxco’s second group of notes features $1 million of 4.5% senior notes due 2023.

According to Medtronic, it intends to fully and unconditionally guarantee all of Medtronic Luxco’s obligations under the notes. The company guarantees this on a senior, unsecured basis.

Medtronic said in a news release that it expects to use proceeds to repay indebtedness. It expects t…

Medtronic reveals more details on surgical business consolidation

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today confirmed its consolidation of its Surgical Robotics and Surgical Innovations operating units into a single Surgical operating unit and said it would not close its facilities in Colorado and Connecticut.

MassDevice was first to report the operating unit consolidation and promotion of former Surgical Robotics President Mike Marinaro to lead the new group.

Medtronic said the consolidation took effect Feb. 1.

“By combining these businesses, Medtronic will capitalize on one of the most attractive markets in all of healthcare — a market that is forecasted to nearly double over the next 10 years,” Medtronic said in a statement to MassDevice. “Our offices and campuses around the globe foster collaboration, build connectivity and community, drive innovation, and enable us to engage with customers. Surgical robotics operations in Colorado and Conn…

Medtronic turns to third-party developers to boost GI Genius’ AI

The GI Genius module’s AI-based enhancements include green boxes that highlight areas that may need extra scrutiny during a colonoscopy. [Image courtesy of Medtronic]

Medtronic has turned to Nvidia to enable an AI Access platform to boost the GI Genius intelligent endoscopy module’s capabilities.

Think of a software-based business model — an app marketplace — where third-party developers create new AI tools to boost early colorectal cancer detection during colonoscopies. It’s a type of product development strategy that may become more common among medical device companies, especially as they shift toward more innovation in the digital space.

The world’s largest medtech company points to GI Genius as the first FDA-cleared, AI-assisted colonoscopy tool that helps physicians detect polyps leading to colorectal cancer. Cosmo Pharmaceuticals, GI Genius’s developer and manufactur…

Medtronic combines surgical robotics and surgical innovations units

Medtronic’s Hugo robot-assisted surgery system [Image courtesy of Medtronic]A senior Medtronic executive’s promotion is the latest piece of the puzzle as the world’s largest medical device company seeks significant expense reductions.

Mike Marinaro, who became president of Medtronic’s Surgical Robotics operating unit one year ago, is now EVP and president of Medtronic’s Surgical operating unit.

Fridley, Minnesota-based Medtronic (NYSE:MDT) didn’t announce the changes in a press release or a regulatory filing.

Instead, the medtech manufacturer quietly updated its website to reflect Marinaro’s new title and the “newly created” operating unit, “bringing together a legacy of surgical devices and the new robotic-assisted surgery technology to redefine the future of surgery.”

It’s not clear exactly when Medtronic updated the website, which said Marinaro was “recently appointed” t…

Medtronic wins CE mark for Affera ablation system

The all-in-one Sphere-9 catheter for mapping and ablation. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system.

The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides real-time feedback through its mapping and navigation software.

Sphere-9 combines with the mapping and navigation system to generate sophisticated electro-anatomical maps. These allow the physician to deliver wide-area focal ablation lesions of choice between RF or PFA. The catheter features a nitinol 9mm ablation tip that may allow for fewer focal ablation lesion applications. Medtronic said it could result in lower procedure times compared to standard irrigated ablation catheters. The compa…

Medtronic and DaVita’s dialysis venture appears to be called Mozarc Medical
Regulatory filings indicate a medtech CEO is involved in the new kidney care company.

Medtronic has filed trademark applications for this Mozarc logo. [Image via the U.S. Patent and Trademark Office]Clues are pointing to Mozarc Medical as the name of the new kidney care company that Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) are expected to launch this year.

The companies used “NewCo” as a placeholder when announcing the new company last year and said a renaming and rebranding would come when the deal closes sometime in 2023.

Since then, Medtronic has filed trademark applications with the U.S. Patent and Trademark Office for Mozarc and Mozarc Medical relating to dialysis products.

Medtronic listed itself as the applicant on five applications filed in August and December. Four more recent applications, filed in January, list Mozarc Medical US LLC as the applicant. All list the same attorney of record and the address of Medtronic’s Fridley, Minnesota headquarters.

Meanwhile, law firm DLA Piper — which represents Medtro…