Medtronic Archives - Page 21 of 59 - Medical Design Sourcing

FDA clears Medtronic patient monitor for procedural sedation and medical-surgical units

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its RespArray patient monitor.

Fridley, Minnesota-based Medtronic designed RespArrayfor procedural sedation and medical-surgical units. It features Nellcor pulse oximetry and Microstream capnography.

RespArray also offers electrocardiogram (ECG), non-invasive blood pressure (NiBP) and temperature monitoring. Its smart algorithms help to detect respiratory compromise early and reduce alarm fatigue.

Medtronic said in a news release that it plans for a limited market release in the fourth quarter of 2022. A full-market release is earmarked for early 2023. The company said the system helps with the increased need for attention for patients in procedural sedation and medical-surgical units as staffing shortages and clinician burnout caused a decrease in patient safety.

According to Medtronic, improved continuous monitoring and response help to prevent 97% …

Join us at DeviceTalks West, the World’s Fair of Medtech

Intuitive Surgical CEO Gary Guthart will participate in a keynote interview at DeviceTalks West 2022. [Photo courtesy of Intuitive Surgical]

October’s DeviceTalks West conference is focused on the future.

The best-seller “Devil in the White City” may have darkened the perception of world’s fairs, but these international convocations have long presented visitors with an optimistic and hopeful view of the future, thanks in no small part to new technology. (The next one is scheduled for 2025 in Osaka, Japan, by the way.)

I like to think we’ll be following similar guidelines at the upcoming DeviceTalks West conference, which will be held on Oct. 19-20 at the Santa Clara Convention Center.

This event will bring together executives from Abbott, Boston Scientific, Edwards Lifesciences, Intuitive, Johnson & Johnson, Medtronic, Outset Medical, Penumbra, Shockwave, Zimmer Biomet and many …

Study backs next-gen Medtronic MiniMed 780G insulin pump

The Medtronic MiniMed 780G system. [Image from Medtronic]Medtronic (NYSE:MDT) today announced positive results from a study of its next-generation MiniMed 780G automated insulin delivery system.

Results from the ADAPT study, published in The Lancet Diabetes & Endocrinology, demonstrated improved glycemic control and treatment satisfaction among users of MiniMed 780G.

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

Medtronic, BioIntelliSense partner on distribution of wearable patient monitoring device

The BioButton from BioIntelliSense

Medtronic (NYSE:MDT) announced today that it partnered with BioIntelliSense on distribution rights for the BioButton device.

BioButton, a multi-paremter wearable for continuous, connected monitoring, measures up to 1,440 vital sign measurements per day. Its measurements include skin temperature, respiratory rate at rest, and heart rate at rest.

The device, combined with advanced analytics, helps clinicians to better detect early signs of patient deterioration. Conversely, it can help to identify stable patients who may be candidates for earlier hospital discharge.

BioIntelliSense’s rechargeable device also offers configurable acute and post-acute modes, according to a news release. These modes help to continuously monitor patients transitioning from higher to lower acuity settings.

The partnership enables the Medtronic patient monitoring business to offer access to a medical grade device that provides conti…

Medtronic completes Affera acquisition

Medtronic (NYSE:MDT) announced today that it completed its acquisition of cardiac mapping and ablation technology developer Affera.

Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib.

In January, Medtronic announced an agreement to acquire Affera, with CEO Geoff Martha labeling the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference, adding that it includes a $250 million contingent consideration.

The company had been a strategic investor in Affera through its minority investment portfolio. Prior to the acquisition, Medtronic held a 3% stake in the company.

According to a news release, the acquisition expands Medtronic’s cardiac ablation portfolio. The portfolio will now include its first-ever cardiac m…

Medtronic implantable cardioverter defibrilator meets trial endpoints

Medtronic (NYSE:MDT) announced that its investigational EV ICD (implantable cardioverter defibrilator) system met trial endpoints.

The medtech giant designed its EV ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). Medtronic’s device aims to avoid certain risks of traditional, transvenous ICDs as its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach.

Placement in such a location aims to help avoid long-term complications that may be associated with leads in the heart and veins, including vessel occlusion and risks for blood infections.

Results from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine, according to a news release…

Medtronic recall of HeartWare HVAD batteries is Class I

Medtronic’s HVAD [Image courtesy of Medtronic]The FDA today issued a notice deeming the recall of the Medtronic (NYSE:MDT) HVAD batteries as Class I, the most serious kind.

Medtronic recalled the HeartWare Ventricular Assist Device (HVAD) batteries (model number 1650DE) because they may experience electrical faults that cause them to fail unexpectedly. Such an occurrence means the batteries may be unable to power the controller, unable to accept a charge from the battery charger or appear to remain charged when in use.

If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death, according to the FDA notice.

The medtech giant has recalled 23,372 devices, distributed from Jan. 1, 2009, to the present day, after initiating the recall on June 28, 2022. To date, Medtronic has reported 1,159 complaints, six injuries and one …

Medtronic sticks by guidance amid unpredictable times

Medtronic (NYSE:MDT) today reported first-quarter results that beat The Street by a whisker, sticking by its full-year guidance amid a tough economic environment.

The medtech giant’s management has increasingly faced questions from analysts who wonder if they can execute through an unpredictable macroeconomic environment that includes a strong dollar (which impacts the ability of U.S companies to sell outside the country), inflation, supply chain disruption and more.

In this morning’s news release, CEO Geoff Martha insisted that can indeed get the job done: “The company continues to execute in a challenging environment, delivering organic revenue above our guidance.”

Can Medtronic accelerate growth?

Martha has had ambitious goals since he took over Medtronic’s corner office in 2020. That included engaging in a major reorganization to make the $32-billion-a-year company more nimble and competitive. Medtronic, however, has suffered …

16 surgical robotics companies you need to know

Intuitive remains the dominant surgical robotics company, but corporations ranging from Medtronic to Vicarious Surgical look to compete. The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive]Robotic-assisted surgery remains one of the hottest spaces in medtech. Intuitive, which pioneered the field in the 1990s and early 2000s, continues to innovate. At the same time, a host of other companies are looking to compete.

Companies making headlines in the robotic surgery space over the past year include:

Company Robotic system(s) Intuitive Surgical Da Vinci Xi, Da Vinci X, Da Vinci SP, Ion Medtronic Hugo Johnson & Johnson Monarch, Velys, Ottava Stryker Mako Siemens Healthineers’ Corindus CorPath GRX Vicarious Surgical Beta 2 Titan Medical Enos Asensus Surgical Senhance Moon Surgical Maestro Momentus Surgical Anovo Virtual Incision MIRA Stereotaxis Genesis RMN, Vdrive, Niobe Monteris …

Analysts ask: Can Medtronic leaders execute?

Medtronic CEO Geoff Martha has had ambitious goals for the world’s largest medtech company. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) — the world’s largest medical device company — will have to settle some doubts as it seeks to navigate through challenging economic times.

That seemed to be the big message in a report out today from Needham & Co. analysts. They previewed what they expect from Medtronic’s Q1 results release on Aug. 23.

“Current guidance requires a steep ramp in revenue and EPS growth through FY23. While comps do get progressively easier, we lack confidence in Medtronic’s ability to execute in a challenging macro environment with multiple factors outside its control,” said Mike Matson, David Saxon and Joseph Conway at Needham & Co.

Medtronic is facing challenges

Geoff Martha has had ambitious goals since he took over Medtronic’s corner office in 2020. That included engaging in a major …

Medtronic announces cash dividend for Q2 2023

Medtronic (NYSE:MDT) announced that its board approved a fiscal 2023 second-quarter cash dividend of 68¢ per ordinary share.

The approval, which came on Thursday, Aug. 18, 2022, represents an 8% increase on the prior year and is consistent with the dividend announcement made by the company in May 2022.

Medtronic increased the cash dividend to 68¢ per share, effective May 25, 2022. The increase translates to an annual amount of $2.72 per ordinary share and marks the 45th consecutive year in which the dividend payment increased. The dividend is payable on Oct. 14, 2022, to shareholders of record at the close of business on Sept. 23, 2022.

According to a news release, Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for 45 consecutive years.

Medtronic will announce its 2023 first-quarter results on Tuesday, Aug. 23, 2022.

What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic

Dr. Laura Mauri is an SVP and the chief scientific, medical and regulatory officer at Medtronic. [Photo courtesy of Medtronic]

Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics.

It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting about the safety of a product.

A drug-coated balloon for lower leg angioplasty offered long-lasting relief to patients who had pain when walking, but outside investigators had questions about whether the device increased patient mortality, Mauri told DeviceTalks Editorial Director Tom Salemi in a new interview.

“This created kind of a firestorm,” she said. “I had experienced firestorms like that in the past and other subject areas and been r…