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…
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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…

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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…

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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…

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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…

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DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

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How this medtech molder is navigating challenging times

Mark Gomulka is the CEO of Westfall Technik. [Photo courtesy of Westfall Technik]

5 questions with Westfall Technik CEO Mark Gomulka

Mark Gomulka has had a busy first year as CEO of plastics contract manufacturer Westfall Technik.

Gomulka joined Las Vegas–based Westfall Technik in September 2021 after five years at Flex and 15 years at Nypro before that.

Formed in 2017 with 20 acquisitions closed and more on the way, the end-to-end plastics manufacturer’s revenue is now around $400 million per year with approximately 20% year-over-year sales growth, Gomulka said.

“I’m having fun doing this, because I think we’re creating something,” Gomulka said in an interview. “We have 2,500 employees. That means we serve 2,500 families. And most importantly, we have incredible customers that took a gamble on us and continue to take a gamble on a company that five years ag…

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The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

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5 tips from medtech leaders for the next generation

Mike Mahoney is chair and CEO of Boston Scientific. [Photo courtesy of Boston Scientific]

When interviewing senior executives on our DeviceTalks podcasts I always start by asking how they got into medtech.

Starting at career square one allows us to walk through the decisions that led to their success. I like to spend a few minutes examining those critical crossroad moments when the guests chose to leap into a new opportunity.

These interviews are full of lessons and tips for younger medtech professionals to equip themselves with experience and insights that will help develop them into leaders of the future.

RELATED: Move over baby boomers, former Medtronic CEO Bill George says

You’ll need to listen to our past episodes for every bit of great advice. But we pulled these particularly helpful tidbits to help you build your successful career.

Tip 1: Run to the fire

Michael Mahoney surpri…

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Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

[Image from the Acutus Medical website]Acutus Medical (Nasdaq:AFIB) announced today that it achieved its second milestone under an asset purchase agreement with Medtronic (NYSE:MDT).

The milestone covers submission for CE mark of the Acutus left-heart access portfolio under EU MDR. Hitting the milestone triggered a $17 million earnout payment from Medtronic to Acutus.

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million. In June, the company completed the first two closings of its deal to sell the devices to Medtronic. In October, Acutus completed the first $20 million milestone under its asset purchase agreement with the medtech giant. Beginning Jan. 28, 2023, Acutus becomes eligible to receive four years of revenue-based earnouts under the deal.

The Acutus left-heart access portfolio includes the AcQCross line of sheath-compatible septal crossing devices. It also features the AcQGuide Mini, AcQGuide Flex an…

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Move over baby boomers, former Medtronic CEO Bill George says

“It’s time for a new generation,” said Bill George, who’s released a new Emerging Leader Edition of his book, “True North.” [Photo courtesy of Bill George]

The medtech veteran offers his advice for leaders in the industry — and how to make opportunities for aspiring leaders to rise.

Bill George’s leadership experience speaks for itself. 

He served as chair and CEO of Medtronic across the 1990s and into the mid-2000s. That came after stints as an executive with Honeywell and Litton Industries. Since 2004, he has taught leadership at Harvard Business School, where he now holds the role of executive fellow. 

George recently published a new version of his book, “True North: Emerging Leader Edition.” In it, he discusses the need for a transition to a new crop of leaders. He spoke with Medical Design & Outsourcing about his book, leadership in the m…

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Siemens Healthineers, GE HealthCare reportedly express interest in Medtronic units

According to reports, Siemens Healthineers and GE HealthCare registered interest in acquiring business units from Medtronic (NYSE:MDT).

Bloomberg first reported the interest from the two companies in two units Medtronic plans to spinoff. The outlet cited people familiar with the matter.

In October, Medtronic announced its intention to pursue a separation of the company’s Patient Monitoring and Respiratory Interventions businesses. Both comprise part of the company’s Medical Surgical portfolio. In spinning those businesses off, the company aims to create value for itself and shareholders, CEO Geoff Martha said.

According to Bloomberg, sources indicated that Medtronic remains open to a sale at the right price. The report also said it values the businesses at more than $7 billion. Others registering interest include private equity firms, Bloomberg said.

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