How Recor Medical won the renal denervation race for FDA approval

The Recor Medical Paradise ultrasound RDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. [Illustration courtesy of Recor Medical]

It’s been a long wait to see the FDA approve renal denervation for treating hypertension.

Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN system. While they were celebrating, the team learned that the very first commercial procedure had just been completed.

“After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done —  they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotiona…

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Here’s what diabetes tech companies are doing on World Diabetes Day

Every November, the diabetes community comes together to recognize both National Diabetes Month in the U.S. and World Diabetes Day.

World Diabetes Day falls on today, Nov. 14, to mark the birthday of Sir Frederick Banting. Banting discovered the insulin hormone along with Charles Herbert Best in 1922.

In an effort to drive awareness and understanding of the chronic condition, a number of medtech companies in the diabetes space undertake efforts each year to celebrate and draw attention to the day and month recognizing the community. We compiled lists in 2021 and 2022 to share some of the initiatives brought forward by these companies.

On World Diabetes Day in 2023, here is what medtech’s diabetes community is doing:

Abbott

Abbott (NYSE:ABT) launched its new “Countdown at a Crossroads” initiative to mark National Diabetes Awareness Month.

The initiative features an animated installation promoting diabetes awareness at the Oculus Center…

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Medtronic brings Blue Balloon Challenge to World Diabetes Day

[Image from Medtronic]To mark World Diabetes Day and National Diabetes Month in the U.S., Medtronic (NYSE:MDT) is bringing back its “Blue Balloon Challenge.”

Introduced in 2021, the movement encourages people with diabetes to help drive awareness and understanding of the chronic condition. The company instructs people to take a video or photo while bouncing a blue balloon in the air with the hashtag #BlueBalloonChallenge. Notable advocates including actress Jennifer Stone and former NFL player Kyle Rudolph took part.

For every #BlueBalloonChallenge post on social media, Medtronic will donate $5 to Life for a Child organization. Life for a Child partners with diabetes centers across 44 countries, including Tanzania, Mexico, and India to help young people with diabetes who have no other care available.

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

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FDA deems stolen Medtronic scopes problem a Class I recall

Conforming devices can be identified by their serial number. [Image courtesy of Medtronic]The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT) + McGrath Mac video laryngoscopes is Class I, the most serious kind.

Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products.

The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation.

Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment.

More details on the Medtronic recall

The recall affects 5,709 dev…

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Acutus Medical is laying off more than half of its workers

Acutus Medical (Nasdaq:AFIB) announced today that it will lay off 65% of its workforce as part of a major restructuring.

The Carlsbad, California–based company’s most recent annual report lists 225 workers at the end of 2022, which means the layoff could involve roughly 146 workers.

Restructuring will involve winding down Acutus Medical’s EP mapping and ablation business, including the AcQMap mapping system, the AcQMap 3D mapping catheter, the AcQBlate force-sensing ablation catheter, the AcGuide Max 2.0 steerable sheath, and associated accessories. (The company said  it will support AcQMap procedures with a small group of therapy managers through Nov. 30.)

Acutus Medical’s main remaining focus will be the manufacturing of left-heart access products for Medtronic. It sold its left-heart access portfolio to Medtronic for $50 million last year, and has brought in tens of millions of dollars worth of milestone payments from the deal since …

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NICE recommends automated insulin delivery tech rollout in UK, Medtronic, Dexcom applaud

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]An independent committee of the National Institute for Health and Care Excellence (NICE) voiced support for closed-loop insulin delivery.

The UK-based institute recommended offering automated insulin delivery (AID) for people whose type 1 diabetes is not controlled with their current device despite best possible management with an insulin pump or real-time or intermittently scanned continuous glucose monitoring (CGM).

Hybrid closed-loop systems utilize a CGM attached to the body that sends data to a body-worn insulin pump. They calculate the necessary insulin delivery to the body to keep blood glucose levels within a healthy range.

NICE, with NHS England, agreed to first offer hybrid closed-loop systems to certain people who already have an insulin pump. These include all children, young people, and women who are pregnant or planning a pregnancy. It comprises part of a five-year rollo…

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9 tips for implementing AI in medical devices from a Medtronic executive

Patients and healthcare providers remain at the core of successful AI implementations in medtech. [piai/Adobe Stock]

It seems like artificial intelligence (AI) is ubiquitous in the healthcare landscape, but the technology remains nascent in the industry. Technologies ranging from machine learning to natural language processing and beyond promise to help make diagnoses and treatment more precise, efficient, and personalized.

But the allure of AI can sometimes overshadow the central goal of addressing tangible clinical problems.

During his talk at DeviceTalks West, Ha Hong, chief AI officer at Medtronic Endoscopy, underscored the importance of putting patients and healthcare providers at the forefront when incorporating AI into medical devices.

With a plethora of AI tools at our disposal — many of which are increasingly user-friendly — the onus is on us to wield them responsibly. Below, you’ll find …

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Medtech hubs win Commerce Department designation in funding competition

The Minneapolis-St. Paul metro tech hub is competing for federal funding to advance medtech innovation and jobs. (Photo by Nicole Harrington via Unsplash)

The Biden Administration has designated the Minneapolis-St. Paul metro and Puerto Rico as medtech hubs in a U.S. Department of Commerce competition for $500 million in funding.

The U.S. Department of Commerce’s Economic Development Administration (EDA) designated 31 hubs across the country to drive regional innovation and job creation, the agency said this week. All are eligible to apply for $50-$75 million in funding each. EDA will select five to 10 hubs for funding.

The EDA also awarded strategy development grants (SDGs) to fund regional coordination to make them more competitive for future funding. Grant recipients include the Phoenix metro’s Medical Device Manufacturing Multiplier Strategy Development Consortium.

EDA-designated tec…

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The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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Medtronic Evolut FX TAVI wins CE mark approval

The Evolut FX system [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + this week announced it received CE mark approval for the Evolut FX transcatheter aortic valve implantation system.

The Evolut FX is the latest generation TAVI of the company’s CoreValve/Evolut TAVI platform. Medtronic designed it to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis.

Evolut FX uses the same supra-annular, self-expanding valve design as the CoreValve/Evolut platform. It has gold markers built into he frame to provide implanters with direct visualization of depth and valve leaflet orientation during implant. Evolut FX uses a redesigned catheter for a smoother insertion profile and more flexible delivery system for a stable, predictable deployment, according to Medtronic.

“With the latest Evolut FX system, we are elevating the p…

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How can medtech companies innovate their business models?

From left: Veronica Acurio, Gio Di Napoli, Brian Montgomery and Simran Sabharwal talked business model innovation at AdvaMed’s The MedTech Conference.

In an ever-changing medtech space, how do companies keep up with the pace of change? How do companies adjust and innovate their business models to reflect that?

Leaders from some of medtech’s biggest names attempted to answer some questions around that at AdvaMed’s The MedTech Conference yesterday. (Want to find out more? Leaders from major medical device companies will discuss innovation in surgical robotics, diabetes tech, cardiovascular and neurovascular tech, oncology and more at DeviceTalks West, Oct. 18–19 in Santa Clara. Register here.)

A panel on “Disruptive Business Models in Medtech: The Next Frontier of Value-Centric Innovation” included:

Veronica Acurio, president of the Medical Solutions division, 3M; Gio Di Napoli, president of the GI operating unit at Medtronic; B…
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How Medtronic, Zimmer Biomet and Smith+Nephew approach medtech M&A

From left, Geoff Martha, Rachel Ellingson and Deepak Nath spoke on a panel about M&A.

In a year with some massive acquisitions in medtech, there are still questions around an overall drop in M&A activity.

According to Pete Cataldo, managing director and medtech head of Truist, deal volume in the sector fell 65% in the first half of 2023. However, despite high interest rates and a volatile stock market, there appears to remain a market for medtech M&A.

For instance, this year brought the merger of orthopedic giants Globus Medical and Nuvasive and Johnson & Johnson’s $16.6 billion acquisition of Abiomed.

The possibilities for M&A are still there, and some of medtech’s biggest names are taking different approaches.

At AdvaMed’s The MedTech Conference, Cataldo moderated a panel called “Medtech M&A: Trends, Strategies, and Opportunities.” It featured Medtronic CEO Geoff Martha, Zimmer Biomet SVP and…

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