Medtronic Archives - Page 10 of 59 - Medical Design Sourcing

Medical nitinol manufacturing: How this nickel-titanium alloy is made for medical devices

Titanium sponge (pictured) is a key ingredient for medical nitinol manufacturing. [Photo by Alexey Rezvykh via Adobe Stock]

Nitinol (NiTi) might be the hottest material in the medical device industry as manufacturers find new applications for this superelastic, shape-memory metal.

Nitinol — an alloy of nickel and titanium — takes a long, hot journey from the Earth’s crust to the deepest parts of the human anatomy. It starts with ore heaved from deep mines undergound or stripped from the soil and refined into titanium and nickel.

To make raw nitinol, suppliers melt pure titanium — in the form of sponge or top-shelf crystal bar — with pure nickel. They must be combined at a roughly 1:1 atomic ratio, which comes out to around 55% nickel and 45% titanium. A nitinol at that ratio would be referred to as nitinol 55.

To be used for medical devices, the resulting nitinol should meet standards set by…

Medicare now covers new Medtronic MiniMed 780G automated insulin pump

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that Medicare now covers its new MiniMed 780G system with the Guardian 4 sensor.

Coverage for the recently FDA-approved automated insulin delivery system extends to all eligible Medicare and Medicare Advantage beneficiaries. Medtronic intends to begin processing orders immediately. The company plans to start shipments to eligible recipients with type 1 diabetes over the next few weeks.

MiniMed 780G features SmartGuard technology to eliminate the need for fingersticks. Its Meal Detection Technology provides automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs. Que Dallara, Medtronic Diabetes EVP and president, told Drug Delivery Business News that this feature is “a big deal.”

Medtronic also presented strong data supporting Meal Time Techno…

July 2023 edition: Life-saving LVADs, supplier innovations and AI breakthroughs

LVADs save lives: So why aren’t more available?

What’s new in 3D printing: medical devices, research, innovation, automation and partnerships

AI breakthroughs in medtech: 7 ways to enhance healthcare

Life-saving LVADs, supplier innovations and AI breakthroughs

Kyree Miller recalls the day his heart stopped beating.

“I remember the entire room going white,” he said. “And I actually turned over on my side and I said, ‘Tell my mom I love her.’”

A couple of weeks later, the heart failure patient — who was only in his 20s at the time — received his first left ventricular assist device (LVAD) implant while he waited for a heart transplant. One year passed, then two, then three. Finally, after surviving on LVAD technology for seven years, his new heart came.

“When you get your transplant, there’s a whole new energy that you get. … But I can honestly say there was a whole new energy that I got when I had my LVAD,” Miller said.

…

FTC critiques Medtronic’s legal reasoning in antitrust case

The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources’ antitrust lawsuit against Medtronic.

Rancho Santa Margarita, California–based Applied Medical filed the lawsuit in February in U.S. District Court in Central California.

The lawsuit accuses the medtech giant of using its size to shut down competition in the U.S. market for advanced bipolar devices used to cut tissue and seal blood vessels. Medtronic responded with a motion to dismiss.

This week, the FTC sought permission from the court to file an amicus brief that would “correct some of Medtronic’s erroneous assertions and mistaken legal points” made in its argument for dismissal.

Medtronic’s legal arguments run against U.S. Supreme Court precedent that anticompetitiveness should not be judged according to a business arrangement’s formal terms but on its its “practical effects,” the FTC said in the brief it wants to submit.

What Applied …

Medtronic applauds new renal denervation guidelines in Europe

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + issued a statement highlighting its excitement over new renal denervation guidelines in Europe.

The European Hypertension Society (ESH) issued updated guidelines on the role of renal denervation in the hypertension care pathway. It announced the guidelines at the ESH 32nd Annual Meeting and simultaneously published them in the Journal of Hypertension.

Medtronic said in a news release that the guidelines mark a turning point for renal denervation as a hypertension treatment. They support its use as a safe and effective complementary treatment option in reducing blood pressure for patients in addition to medications and lifestyle changes.

In September 2022, Medtronic announced study data demonstrating significant blood pressure re…

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]

As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a number of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came …

The biggest stories from the American Diabetes Association (ADA) 2023 Scientific Sessions

From left: the Insulet Omnipod 5, Medtronic MiniMed 780G and the Senseonics Eversense E3. These technologies were part of some of the biggest stories from the American Diabetes Associations’ 2023 Scientific Sessions. [Images courtesy of Insulet, Medtronic and Senseonics]As it does every year, this past week, the American Diabetes Association convened its Scientific Sessions to bring together leaders in the diabetes space.

At last year’s event, next-generation technologies from the big hitters took the spotlight. The 83rd iteration this past week produced a range of new studies, product updates and positive news for a range of technologies and innovations. From continuous glucose monitors (CGMs) to insulin pumps to digital platforms and diabetes reversal procedures, ADA 2023 saw it all.

Usual suspects, like Dexcom, Abbott, Medtronic and Insulet shared their updates. Meanwhile, promising data came out of Senseonics, Sernova, Bigfoot Biomedical and more.<…

CISA warns on cybersecurity vulnerability for Medtronic cardiac device data workflow system

The U.S. Cybersecurity and Infrastructure Security Agency (CISA) issued a warning on the Medtronic (NYSE: MDT) + cardiac device data workflow system.

This vulnerability affects Paceart Optima systems, versions 1.11 and prior.

CISA lists the vulnerability as the deserialization of untrusted data, “exploitable remotely” with “low attack complexity.” The agency says successful exploitation could result in a remote code execution or a denial-of-service condition. This could impact a healthcare delivery organization’s Paceart Optima system.

If a healthcare delivery organization enabled the optional Paceart Messaging Service in the system, an unauthorized user could exploit the vulnerability. The unauthorized user may perform remote code execution and/or denial-of-service attacks, the CISA notice said. They could send specifically crafted messages to the system.

Remote code executi…

CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

Medtronic reports diversity gains and a larger manufacturing footprint

A year-over-year comparison of Medtronic’s latest annual report shows an increase in gender and racial diversity, a larger manufacturing and research footprint and some big moves in its manufacturing locations ranking.

A Medtronic employee checks inventory in Galway, Ireland, where the device maker has significant manufacturing operations. [Photo courtesy of Medtronic]

Medtronic reported gains for women and ethnic diversity in its workforce at the end of its fiscal year, which ended in April 2023

The world’s largest medical device company said in its newly released annual report that women now make up 51% of its global workforce, up from 50% at the end of fiscal 2022.

Diversity in medtech: 2022 markedly the best for women in medtech

Ethnic diversity among Medtronic’s U.S. workers climbed to 40% from 38% a year ago, including 28% of U.S. managers. Medtronic als…

Medtronic appoints Greg Lewis as director

Greg Lewis. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it appointed Greg Lewis to its board of directors.

Lewis currently serves as SVP and CFO at Honeywell. He will serve on the Audit Committee and Finance and Financial Risk Committee as part of Medtronic’s board. His move becomes effective today, June 26, 2023.

“We are thrilled to have Greg Lewis join our Board,” said Geoff Martha, Medtronic chair and CEO. “His background in financial leadership across multiple industries will be a strong asset as Medtronic pushes forward a comprehensive transformation that will set us up to deliver on durable growth.”

Lewis joined Honeywell in 2006. Since then, he took up a variety of financial leadership roles across the company. That includes VP of corporate finance and CFO of Honeywell’s automation and control solutions (ACS) segment.

He began his caree…

New data supports Medtronic MiniMed 780G automated insulin delivery system for children

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today announced positive clinical and real-world data supporting its MiniMed 780G automated insulin delivery system.

The latest data sets evaluated the recently FDA-approved system across a wide range of users. They looked at younger patients, those not meeting glycemic goals and individuals using simplified meal announcement technology. Medtronic presented these results at the 83rd American Diabetes Association (ADA) Scientific Sessions in San Diego.

Among the findings, Medtronic reported positive results for its proprietary Meal Detection technology. MiniMed 780G is the only system with meal detection technology providing automatic adjustments and corrections to sugar levels every five minutes. This occurs for both basal (background) and bolus (mealtime) insulin needs.

Que Dallara, Medtronic Diabetes EV…