Medtronic Archives - Medical Design Sourcing

Biopharma company Chiesi appoints former Medtronic exec as CEO

New Chiesi CEO Giuseppe Accogli. [Image from Baxter India website]

Chiesi announced today that it appointed former Baxter and Medtronic executive Giuseppe Accogli as its new group CEO.

Parma, Italy–based Chiesi said Accogli’s appointment becomes effective April 3, 2023. The R&D-focused pharmaceutical company develops and commercializes products for the hospital, rare disease and adjacent specialty care settings.

Accogli brings 25 years of international experience to Chiesi. The longtime executive leader’s experience includes medtech companies such as Baxter and Medtronic. In addition, his background includes work across multiple disciplines, like sales, marketing, R&D, M&A, strategy and product innovation. In past roles, he focused on the U.S. and EMEA markets.

“I am honored to lead Chiesi into its new stages of growth and I thank the board of directors for their tr…

What to expect in diabetes care in 2023

[Image courtesy of Walmart]

After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, and rumored spinouts and acquisitions.

You can read all about the biggest diabetes stories of 2022 here.

There’s plenty to look forward to in the diabetes space in the months ahead. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time …

The year ahead in diabetes care: what to expect in 2023

[Image courtesy of Walmart] After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, rumored spinouts and acquisitions and more.

You can read all about the biggest diabetes stories of 2022 here.

As we embark on a new year in 2023, there’s still plenty to look forward to in the diabetes space. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time that the decision marked a win for …

Fresenius Medical Care joins health equity pledge

Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland.

As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective vision of “Zero Health Gaps,” making improvements in health equity.

In total, 39 organizations joined the pledge. Medtronic announced yesterday that it took part. Other medtech companies joining include Henry Schein, Hologic and Philips, according to the World Economic Forum.

Fresenius said its involvement marks a commitment to “meaningful action and collaboration toward health equity.”

“We believe that access to equitable and high-quality health care is a fundamental human right, and we are committed to working with global leaders and organizations to improve the lives of millions of…

January 2023 Issue: The Leadership In Medical Technology Issue

Outset Medical CEO Leslie Trigg and the beginner’s mindset

Move over baby boomers, former Medtronic CEO Bill George says

The biggest medtech personnel moves in 2022

5 tips from medtech leaders for the next generation

How this medtech molder is navigating challenging times

Assurea’s co-founder is on a mission to elevate women in pharma

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Titan Medical shows off Enos surgical robot’s next-gen design

Courage to lead – and leap

It’s been a privilege to edit the latest edition of Medical Design & Outsourcing, kicking off 2023 with our annual Leadership in Medical Technology Issue.

Executive Chris Newmarker had the honor last year, as I was on paternity leave with my newborn son. Baby James is now a fearless 1-year-old on the move, scrambling his way to new heights …

January 2023 Issue: The Leadership In Medical Technology Issue

Outset Medical CEO Leslie Trigg and the beginner’s mindset

Move over baby boomers, former Medtronic CEO Bill George says

The biggest medtech personnel moves in 2022

5 tips from medtech leaders for the next generation

How this medtech molder is navigating challenging times

Assurea’s co-founder is on a mission to elevate women in pharma

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Titan Medical shows off Enos surgical robot’s next-gen design

Courage to lead – and leap

It’s been a privilege to edit the latest edition of Medical Design & Outsourcing, kicking off 2023 with our annual Leadership in Medical Technology Issue.

Executive Chris Newmarker had the honor last year, as I was on paternity leave with my newborn son. Baby James is now a fearless 1-year-old on the move, scrambling his way to new heights …

Medtronic signs pledge to advance health equity

Medtronic (NYSE:MDT) today announced that it joined the Global Health Equity Network (GHEN) to drive change in health equity.

GHEN, a World Economic Forum, brings together the private and public sectors to address health equity issues. CEOs and business leaders comprise the forum focused on prioritizing action in organizational strategy and purpose.

“Addressing health equity is critical because more than half the world’s population lacks access to essential healthcare,” Medtronic said in a news release. “And the most challenging health issues disproportionately impact marginalized populations. But we recognize that no one solution or organization can achieve health equity alone; strategic partnerships are essential to accelerating this critical work.”

As part of the GHEN agenda, Medtronic signed the Zero Health Gaps Pledge. This pledge addresses progress in health equity across 10 areas. Committed organizations agreed to help driv…

Intricon launches Biosensors Center of Excellence for medical devices

Biosensors are used in a growing number of smart medical devices, such as Medtronic’s InPen System with Guardian Connect continuous glucose monitor (pictured) [Photo courtesy of Medtronic]

Intricon today said it has launched a new Biosensors Center of Excellence focused exclusively on medical devices.

The St. Paul, Minnesota-based medical device developer and manufacturer said the center of excellence combines Intricon’s biosensor device expertise and capabilities into a vertically integrated business unit focused solely on bringing biosensor medical devices to market.

Intricon CEO Scott Longval [Photo courtesy of Intricon]

“OEMs and startups need an approach like this because there are important intricacies in creating medical biosensor devices versus consumer biosensor products,” Intricon CEO Scott Longval said in a news release. “Th…

Titan Medical meets with strategic buyers and investors as surgical robot developer considers its future

Titan Medical’s Enos surgical robotics system has snake-arm instruments that deploy through a single incision. An Enos 2.0 prototype (pictured here) makes room for a third instrument arm by eliminating the integrated camera and using the 3-D scope. [Photo courtesy of Titan Medical]Titan Medical (Nasdaq:TMDI) met with potential buyers of the surgical robotics company this week in San Francisco.

The Toronto-based medical device developer has been considering the best options for investors and the company’s Enos surgical robot. Facing delisting of its stock from the Nasdaq exchange due to its low price last year, Titan Medical announced a strategic review in November and furloughed staff in December.

Also this week — and probably not coincidentally — the company released details of a second-generation Enos design with improvements such as an increase in the number of instrument arms to three from two. Learn more about those Enos design improvements, including a…

Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical

Left: the Endurant II. Right: the Excluder AAA. [Images from the websites of Medtronic and Gore]Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems.

The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family.

Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the trial. After that, the plan is to randomize patients to receive endovascular aneurysm repair (EVAR). The EVAR would come from either the Endurant or Excluder families of grafts. Follow-up comes at one month, one year and annually throughout five years.

Dr. Ray Workman and his team at Novant Health Forsyth Medical Center (Winston-Salem, North Carolina) enrolled the first patient.

“Through the Advance trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient…

Medtronic has a new chief quality officer

Medtronic chief quality officer Scott Cundy [Image courtesy of Cundy’s LinkedIn page]Medtronic (NYSE:MDT) has hired a top regulatory and quality official at Danaher to be its new chief quality officer, CEO Geoff Martha announced on LinkedIn today.

Scott Cundy rose up through the ranks at Danaher over more than a dozen years at the company. He most recently served as its VP of quality, regulatory and clinical affairs for Diagnostics and Life Sciences Platforms.

The hiring is also a homecoming for Cundy. Before Danaher, — in the early 2000s — he held quality, regulatory and clinical roles in Medtronic’s cardiovascular portfolio.

“His robust background in product quality, engineering, and regulatory — along with deep executional experience and operating rigor — will enable us to continue the crucial and impactful work underway in our safety and quality function,” Martha said.

The previous chief quality officer, Noel Colon, has mo…

The 10 biggest diabetes tech stories from 2022

Some of the biggest diabetes technology developments in 2022. These include the Dexcom G7 (top left), Insulet Omnipod 5 (bottom left), Senseonics Eversense E3 (top right) and Abbott FreeStyle Libre 3 (bottom right. 2022 represented a landmark year for next-generation diabetes technologies. Here are the biggest stories from the past year.

Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.

Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from, but here are 10 big ones that stood out:

Dexcom G7 receives FDA clearance

The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.

Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.

Dexcom COO Ja…