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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.

…

Abbott wins FDA nod for first dual-chamber leadless pacemaker

The Aveir dual-chamber leadless pacemaker. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that it received FDA approval for its Aveir dual-chamber leadless pacemaker system.

The approval marks the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms. According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart — the right atrium and right ventricle.

This approval “significantly increases access” to the pacing technology for millions in the U.S., the company said in a news release.

Approval follows clinical data shared in May that supported Aveir DR. The data came from the company’s large-scale FDA investigational device exemption (IDE) study. Results included a 98.3% implant success rate and more than 97% of patients presenting successful atrio-ventricular synchrony. Abbott said the data sugg…

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.<…

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…

Abbott, ADA partner on therapeutic nutrition program for people with diabetes

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott]Abbott (NYSE: ABT) + and the American Diabetes Association (ADA) announced a collaboration to improve nutrition for people with diabetes.

The duo aims to help better understand how diabetes technology, like continuous glucose monitoring (CGM), can help. They hope to aid people with diabetes make more informed decisions about their food and activity.

Abbott develops a family of CGMs, the latest being the FreeStyle Libre 3. The company said that, over time, data from CGMs helps people with diabetes learn patterns and create a nutritional plan. That plan can help provide steady glucose levels and the potential for improved clinical outcomes, like lower A1C.

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

Insulet makes progress on integrating Omnipod 5 with Abbott FreeStyle Libre 2

The Insulet Omnipod 5 [Photo courtesy of Insulet]Insulet (Nasdaq:PODD) today announced a duo of updates related to its Omnipod 5 system that includes a significant integration development.

The company submitted an updated mobile application for regulatory clearance and aims to integrate Omnipod 5 with the Abbott FreeStyle Libre 2.

Acton, Massachusetts-based Insulet plans to discuss a range of developments related to its product line in the coming days at the American Diabetes Association (ADA) 83rd Scientific Sessions in San Diego. Presentations include real-world evidence of improved outcomes and optimization using the Omnipod 5 automated insulin delivery system.

News of these developments follows the UK launch of Omnipod 5 earlier this week.

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

France expands reimbursement for Abbott FreeStyle Libre 2 to all basal insulin users

The FreeStyle Libre 2 continuous glucose monitor (CGM). [Image from Abbott]Abbott (NYSE: ABT) + announced today that the French health authority approved the expansion of reimbursement coverage for the FreeStyle Libre 2.

FreeStyle Libre 2 previously only had coverage for people with type 1 and type 2 diabetes who require intensive insulin therapy. France’s expansion covers the continuous glucose monitor (CGM) for all people who use basal insulin as part of their diabetes management.

The Abbott Park, Illinois-based company said this expansion enables more access to the CGM in France. Abbott noted that more than 90% of people living with diabetes in France have type 2.

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

FDA approves Surmodics SurVeil drug-coated balloon

Surmodics (Nasdaq:SRDX) + announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB).

Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal arteries. These arteries feature reference vessel diameters of between 4 mm and 7 mm.

Shares of SRDX rose more than 11% to $28 apiece by late morning trading today on the news. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.

SurVeil received CE mark in Europe in June 2020. However, regulatory approval proved harder to achieve in the U.S. In January, the FDA indicated that Surmodics’ SurVeil PMA application was not approvable. The company received formal feedback from the agency in March, th…

Artificial intelligence: What medtech’s top influencers think

Artificial intelligence’s effect on medtech was a question that came up continually during our DeviceTalks Boston show in early May.

Here is what some of the top influencers in the industry had to say:

Boston Scientific CEO Mike Mahoney [Photo courtesy of Boston Scientific]

Boston Scientific CEO Mike Mahoney on artificial intelligence and medtech

“I’ll give you some practical applications. … We have manufacturing plants around the world, and we have great quality systems, and we have great quality engineers who inspect everything, and we have a zillion microscopes looking at every little product that we have all over the world. Our team is leveraging AI capabilities for visualization inspection rather than the human eye constantly doing that with the mistakes that are inherent and scrapping products and so forth. … We’re seeing cost productivity and better quality by just leveraging AI in our…

The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

Abbott changes executive team with new CFO

Abbott (NYSE:ABT) announced today that it made a series of personnel changes, including the appointment of a new chief financial officer.

Effective Sept. 1, 2023, the company appointed Philip Boudreau as SVP, finance, and chief financial officer (CFO). He reports to Robert Funck, whose appointment as EVP, finance, goes into effect the same day. Funck previously held the CFO position. Additionally, Abbott named John McCoy, Jr., VP, controller, effective Sept. 1, according to a news release.

Funck joined Abbott in 1989 and served as a corporate officer starting in 2005. He held the role of SVP of finance and controller before his 2020 appointment to the CFO position. He replaced the retiring Brian Yoor amid a number of changes when Robert Ford took over for outgoing CEO Miles White in early 2020.

Boudreau became Abbott’s VP, controller in 2020 and served in that role since. Before that, he held the position of divisional VP, controller, medical devic…