What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

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Study: Medtronic ICDs can help prevent sudden cardiac death

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today announced data demonstrating improved outcomes with its implantable cardioverter defibrillators (ICDs).

ICDs treat dangerously fast or irregular heart rhythms — ventricular tachycardia or ventricular fibrillation — that can lead to sudden cardiac death (SCD).

Two analyses demonstrated survival benefits nad a reduction in life-threatening cardiac events with the use of ICDs. Data provided real-world evidence supporting the use of Medtronic ICDs for indicated patients. Dr. Angelo Auricchio presented the results at the European Society of Cardiology (ESC) Congress in Amsterdam. Auricchio, the lead author of both analyses, serves as deputy head of cardiology and director of the clinical electrophysiology unit at Fondazione Cardiocentro Ticino in Lugano, Switzerland.

One retrospective analysis demonstrated an association of ICDs …

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Engineers wanted: ReCor Medical’s hiring as its RDN system awaits FDA approval

ReCor Medical’s Paradise renal denervation catheter uses heat (depicted by the red ring) from ultrasound-generated energy for denervation, while cooling with circulating water (depicted by the blue rings) within the artery to protect it from heat. [Illustration courtesy of ReCor Medical]

ReCor Medical is hiring as its Paradise ultrasound renal denervation (RDN) system seems set for regulatory approval following this week’s favorable vote by an FDA review panel.

The Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted in support of the Paradise system’s safety, efficacy and risk/benefit profile for patients with uncontrolled hypertension.

Such a vote is usually a precursor to FDA premarket approval (PMA). The same panel of experts dashed Medtronic’s hopes of securing a PMA for its competing Symplicity Spyral RDN system the following day.

If…

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Medtronic wins CE mark for Inceptiv spinal cord stimulation system

The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received CE mark approval for its Inceptiv spinal cord stimulator (SCS).

Inceptiv, a closed-loop, rechargeable SCS, treats chronic pain. Medtronic said it’s the company’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

According to a news release, certain movements during SCS therapy may result in uncomfortable stimulation. That, in turn, can lead to patients turning down their device’s stimulation output, negating their therapy.

Conversely, Inceptiv senses the body’s neural response to stimulation 50 times per second, every second, every day. When neural response increases — for …

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After Medtronic’s latest setback, what’s next for Symplicity Spyral RDN?

Medtronic’s Symplicity Spyral device is a multi-electrode radiofrequency catheter for renal denervation. [Image courtesy of Medtronic]

Medtronic’s Symplicity Spyral renal denervation (RDN) system for treating hypertension seems less likely now than ever to win FDA approval after yesterday’s vote Circulatory Systems Devices Panel vote.

The panel’s medical and statistical experts voted against recommending approval of Medtronic’s RDN therapy for hypertension under the proposed indications. While they supported approval of ReCor Medical’s competing RDN system one day earlier, a key difference was the failure of Medtronic’s RDN system to outperform hypertension drugs.

Medtronic acquired the technology through its takeover of Ardian in January 2011. Early clinical results were promising, but Medtronic announced in 2014 that its Symplicity HTN-3 trial failed to meet it…

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Medtronic stock is down on new RDN system setback

Medtronic (NYSE: MDT) + stock is taking a hit after an FDA review panel found the risks of its renal denervation system outweighed the benefits. 

The world’s largest medical device company engaged in more than a decade of clinical trials and research — with multiple disappointments along the way — as it made a bet that its radiofrequency-energy-based Symplicity Spyral renal denervation (RDN) would open up a multibillion-dollar market addressing hypertension. High blood pressure is a tough condition to treat, with poor medication adherence and a higher risk of heart attacks, strokes and other serious health events.

But yesterday, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 6-6 (one abstention) — with its chair Dr. Richard Lange casting the deciding vote — to recommend against FDA approval. Along with the vote over risks versus benefits, the panel voted 7-6 in favor o…

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FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other serious events tied to high blood pressure.

The same FDA review…

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FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation catheter delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other seriou…

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Cydar Medical, Medtronic treat first patient in AI mapping collaboration

Cydar Medical today announced the successful treatment of the first patient in a strategic collaboration with Medtronic (NYSE: MDT) + .

The collaboration spans 40 sites across the U.S., UK and Europe, integrating the Cydar Maps software with Medtronic services and case support. The collaboration aims to improve patient care and efficiency with AI-based solutions placed into the clinical environment.

Cydar and Medtronic entered into the collaboration in April 2022. The company also has a strategic partnership with Philips.

Dr. George Pontikis treated the first patient in the pilot program at Edward Hospital in Illinois. He said the technology helped to navigate complex vascular procedures with greater precision.

UK-based Cydar developed its Cydar Maps platform to transform the dissemination of information to clinicians in image-guided minimally invasive surgery. The company designed it to simplify complexit…

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Medtronic pleased with Diabetes progress as new CGM’s FDA review ‘is progressing’

The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic]After ending fiscal 2023 on a high, the Diabetes unit at Medtronic (NYSE:MDT) continues to roll on into the company’s new fiscal year.

To finish fiscal 2023 (in April), Medtronic received FDA approval for its next-generation MiniMed 780G automated insulin delivery system. Shortly after, the company fully resolved a warning letter issue with the FDA.

Medtronic kicked off the first quarter of 2024 with its Diabetes unit helping to drive the company’s overall growth. Highlights included the U.S. launches for the MiniMed 780G automated insulin delivery system, which led to led to 6.8% revenue growth year-over-year for Medtronic Diabetes.

The quarter also brought news of a planned $738 million acquisition of insulin delivery technology developer EOFlow. Additionally, Medtronic shared progress on its next-generation CGM pipeline.

Get the full s…

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Medtronic stock rises on strong Q1 results, increased guidance

Medtronic (NYSE: MDT) + shares ticked up today on first-quarter results that came in ahead of the consensus forecast.

The company reported growth stemming from its Diabetes and Cardiac Rhythm business units, while it also reported sustained progress with its Hugo surgical robot.

Shares of MDT rose 3.6% at $84.55 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly.

The medtech giant posted profits of $791 million. That equals 59¢ per share on sales of $7.7 billion for the three months ended July 28, 2023.

Medtronic recorded a 14.9% bottom-line slide on sales growth of 4.5%.

Adjusted to exclude one-time items, earnings per share totaled $1.20, landing 9¢ ahead of Wall Street expectations. Sales also topped the forecast as analysts projected $7.6 billion in revenue.

“W…

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How Abbott designed the world’s first dual-chamber leadless pacemaker system

Abbot’s Aveir DR (left) and VR (right) leadless pacemakers communicate wirelessly with each other from different chambers of the heart. [Image courtesy of Abbott]

The lead engineer on Abbott’s Aveir project explains how his team developed a first-of-its-kind wireless pacemaker system that communicates through blood.

When Abbott’s Aveir DR pacemaker system became the first approved by the FDA for dual-chamber pacing this year, it expanded the benefits of leadless pacing to the majority of patients who need stimulation of both the atrium and ventricle chambers.

The lead engineer on the Aveir project, Matthew Fishler, was working on leadless pacemaker technology at Nanostim when it was acquired by St. Jude Medical in 2013. (Abbott then purchased St. Jude in 2017.) He traced the idea for a dual-chamber leadless system in an effort to eliminate lead failures and other complications of tradition…

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