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The LINQ II ICM is the first continuous, long-term cardiac monitor cleared by FDA for the pediatric patient population

- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the LINQ II™ Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

"For pediatric cardiologists who see many young patients needing continuous, long-term monitoring for infrequent or unknown heart rhythm conditions, this expanded indication for the LINQ II ICM is critically important," said Jennifer Silva , M.D., director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children's Hospital. "The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients."

The LINQ II system is a small (one-third the size of a AAA battery), wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) and chest pain, thereby requiring long-term monitoring or ongoing management. The LINQ II ICM, which has a battery life of up to 4.5 years 1 , allows patients to undergo magnetic resonance imaging (MRI) when needed, and, as an implantable device, does not interfere with daily activities such as showering, bathing, or swimming. The latest-generation device has been implanted in thousands of patients globally since it was first commercialized in 2020.

"As a result of this milestone, physicians will be able to provide actionable data to help diagnose underlying heart conditions and define treatment protocols in our younger patients with abnormal heart rhythms," said Julie Brewer , president of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic. "And parents can have peace of mind knowing their child's heart is being monitored continuously, and their doctor will be notified of abnormal heartbeats."

The LINQ II ICM system also includes the recently launched AccuRhythm™ AI algorithms, which applies artificial intelligence (AI) to heart rhythm event data collected by the LINQ II ICM, improving the accuracy of information physicians receive so they can better diagnose and treat abnormal heart rhythms. The two AI algorithms have shown to reduce the number of false alerts specific to the most common ICM false alerts — atrial fibrillation (AF) and pause (asystole) — by 74.1% and 97.4% respectively, 2, 3 while preserving more than 99% of true alerts. 4, 5

With integrated remote patient management, patients or their caregivers can choose to use their smartphones with the LINQ II ICM to automatically transfer device data via the MyCareLink Heart™ mobile app using BlueSync™ technology that enables secure communication via Bluetooth.

Medtronic has been a pioneer in the development of insertable cardiac monitors for more than 20 years; to date, more than 1.7 million patients have received a Medtronic ICM. 6

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References:

1 Nominal settings. LINQ II™ LNQ22 ICM clinician manual. M974764A001D.
2 Radtke A, Ousdigian KT, Haddad TD, et al. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. Heart Rhythm Journal. Published online August 1, 2021 .
3 Cheng YJ, Ousdigian KT, Koehler J, et al. Innovative Artificial Intelligence Application Reduces False Pause Alerts while Maintaining Perfect Trye Pause Sensitivity for Insertable Cardiac Monitors. Presented at Heart Rhythm Society Conference July 31, 2021 .
4 The pause algorithm preserved 100% of true pause alerts.
5 The AF algorithm preserved 99.3% of true AF alerts.
6 Medtronic Reveal™ Publications. Medtronic data on file. 2022.

Contacts:




Joey Lomicky

Ryan Weispfenning

Public Relations

Investor Relations

+1-612-239-1823

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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Energy Fuels Announces Q2-2022 Results, Including Continued Robust Balance Sheet and Market-Leading U.S. Uranium & Rare Earth Positions

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  • Validation of Cloud DX's Vitaliti™ continuous monitoring device clears way for regulatory approval starting in 2022.
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Cloud DX (TSXV:CDX)(OTCQB:CDXFF), Leading Virtual Care Platform Cloud DX has announced publication of an independent peer-reviewed validation study of its unique Vitaliti™ product, a non-invasive wearable devices that provides continuous vital sign monitoring (CVSM) device. The study assessed regulatory compliance and post-surgery use in monitoring patients' vital signs in real-world conditions. The study found Vitaliti™ to be fully ISO 81060-2:2018 compliant for the continuous vital measurement, clearing the way for regulatory approval starting in 2022. The study also found that patients welcomed the comfortable, easy to use device. Instead of care teams taking vitals periodically after surgery, Cloud DX's Vitaliti™ was used for continuous monitoring, which could transform post-surgical care by enabling early detection if any deterioration occurs in patient health. On launch, Vitaliti™ will become a key component of Cloud DX's Connected Health™ ecosystem of remote monitoring technologies. Through Cloud DX's recent partnership with Medtronic Canada ULC (a subsidiary of Medtronic plc (MDT), a global leader in healthcare technology), wide deployment of Vitaliti™ is intended to initially improve post-operative care for surgical patients in Canada (up to 800,000 annually) and eventually in the United States (up to several million annually

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InvestmentPitch Media Video Discusses Cloud DX's Selection by Medtronic for Canada-Wide Remote Patient Monitoring - Video Available on Investmentpitch.com

Cloud DX Inc. (TSXV: CDX) (OTCQB: CDXFF) has been selected by Medtronic Canada ULC, to provide world-class virtual healthcare to Medtronic's patients across Canada. Medtronic Canada, (www.medtronic.ca) headquartered in Brampton, Ontario, with regional offices in Montreal and Vancouver, is the largest medical technology company in Canada, and a subsidiary of Medtronic plc (NYSE: MDT), a multi billion-dollar, global leader in medical technology, offering medical devices and therapies to more than 72 million people across 150 countries.

For more information, please view the InvestmentPitch Media "video" which provides additional information about this news and the company, along with comments from Robert Kaul, CEO of Cloud DX, about the significance of this news. If this link is not enabled, please visit www.InvestmentPitch.com and enter "Cloud DX" in the search box.

This partnership advances Medtronic's commitment to improving patient outcomes and lowering overall costs along the care continuum. Medtronic Canada delivers care in a broad range of clinical areas, including spinal and cardiac surgeries, cardiology, critical care, diabetes, vascular and renal care. Most clinical areas are expected to improve patient outcomes and satisfaction with some aspect of virtual care in the future.

Cloud DX's Connected Health™ remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Its partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources.

Cloud DX's remote patient monitoring technology and services are exclusive to Medtronic and its Canada-wide client base. Initially, Medtronic seeks to integrate the Connected Health™ platform and associated services within both perioperative and complex chronic disease pathways in Canada.

Under the agreement, a typical deployment would involve the enrollment of a chronic care or surgical patient onto the Connected Health™ platform, generating recurring revenue, depending on the length of the monitoring program. Cloud DX generates revenue upfront for kits prescribed to patients for use at home, and then a monthly subscription fee per patient for software, services, and support. Additional revenues could also be generated through customizations, consulting, and special services, as needed.

Jessica Rudd, National Director of New Partnerships and Solutions at Medtronic Canada, stated: "Medtronic is committed to partnering with Canada-based SMEs to advance the Canadian life sciences ecosystem. More importantly, Medtronic Canada is dedicated to responding to the needs of our Canadian healthcare system, and we are committed to enabling equitable access to care and patient empowerment and reducing the burden on our precious health human resources. However, we can't do this alone. To that end, we are delighted to enter this exclusive partnership with Cloud DX and scale their innovative technology, thoughtful service model, and excellent track record for delivering results to patients across the country."

Among its many awards, Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of " Canada's Ten Most Prominent Telehealth Providers.

The shares are trading at $0.195. For more information, please visit the company's corporate website www.CloudDX.com, and the company's investor relation site ir.CloudDX.com/overview/default.aspx, contact Jay Bedard, Investor Relations, at 647-881-8418 or by email at jay.bedard@CloudDX.com.

About InvestmentPitch Media

Investmentpitch Media leverages the power of video, which together with its extensive distribution, positions a company's story ahead of the 1,000's of companies seeking awareness and funding from the financial community. The company specializes in producing short videos based on significant news releases, research reports and other content of interest to investors.

CONTACT:
InvestmentPitch Media
Barry Morgan, CFO
bmorgan@investmentpitch.com

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