AI Analysis | Feedback

Here are 1-3 brief analogies for iRadimed (IRMD):

• Medtronic for MRI environments.
• Baxter International for MRI-compatible IV systems and patient monitors.
• Stryker, but for MRI-safe patient care devices.

AI Analysis | Feedback

• IRADIMED 3880 MRI-compatible IV Infusion Pump System: An IV infusion pump system specifically designed for safe and accurate fluid and medication delivery within the MRI environment.
• IRADIMED 3860 MRI-compatible Patient Vital Signs Monitoring System: A patient vital signs monitor built for continuous monitoring of key physiological parameters within the MRI suite.
• MRI-compatible Consumables and Accessories: Various disposable items and accessories, such as IV sets, patient cables, and sensors, essential for the operation of their primary systems within the MRI environment.

AI Analysis | Feedback

iRadimed (IRMD) sells primarily to other companies, specifically healthcare institutions. While they do not have "major customers" in the sense of specific entities that individually account for a significant portion of their revenue (as no single customer represents more than 10% of their total revenues, according to their SEC filings), their customer base primarily consists of the following categories of organizations:

• Hospitals: These are the primary purchasers of iRadimed's MRI-compatible IV infusion pump systems, IV lines, accessories, and patient vital signs monitoring systems for use in their radiology and imaging departments.
• Other Healthcare Providers: This category includes outpatient imaging centers, ambulatory surgery centers, and other specialized clinics that perform MRI procedures.
• Government Accounts: This refers to governmental healthcare facilities and agencies, such as Veterans Affairs (VA) hospitals in the United States, that utilize iRadimed's products.

AI Analysis | Feedback

AI Analysis | Feedback

Roger Susi, Founder, President, and CEO

Mr. Susi founded iRadimed Corporation in 2004. He possesses over 25 years of management experience within the medical device industry. Notably, he was also the founder, Chairman, and Chief Executive Officer of Invivo Research Inc., a medical device company that pioneered MRI-safe patient monitoring. He served as President of Invivo Research Inc. from 1979 through 1998 and as a director of Invivo Corporation from 1998 through 2000.

John "Jack" Glenn, Chief Financial Officer

Mr. Glenn has served as Chief Financial Officer of iRadimed since 2022. He is a financial executive with over 30 years of experience in corporate finance activities for both public and private companies, demonstrating a track record of significantly growing enterprise value. Before joining iRadimed, Mr. Glenn served as Chief Financial Officer at Esko Bionics, and his prior experience includes CFO roles at Sonendo, Armetheon, Solta Medical, Cholestech, and Invivo Corporation.

Jeff Chiprin, Chief Commercial Officer

Mr. Chiprin has been the Chief Commercial Officer since November 2024, bringing over 30 years of senior leadership experience in medical technology from both private and public sectors. He joined Invivo Corporation in 1996, where he served as Vice President of North American Sales for six years, and was part of the leadership team involved in the sale of Invivo Corporation to Philips Corporation. Subsequently, he spent 14 years as Vice President of Sales at Philips Corporation.

Randy Waddell, Vice President of Worldwide Sales & Marketing

Mr. Waddell is an experienced sales leader, focusing on developing growth-centered sales organizations and designing strategic business plans. Prior to his career in the medical device industry, he spent 11 years in the office products business.

Chris Williamson, Executive Vice President of Continuous Improvement & Information Technology

Mr. Williamson is responsible for leading transformation initiatives aimed at supporting growth, maximizing operational efficiency, and enhancing profitability. He brings over 20 years of experience in technology, business transformation, and operations from companies within highly regulated industries.

AI Analysis | Feedback

The key risks to IRadimed's business include its significant reliance on a limited product portfolio, ongoing regulatory challenges, and the potential for increased competition.

1. Reliance on Limited Product Portfolio: IRadimed's business is heavily concentrated on its MRI-compatible intravenous (IV) infusion pump system and patient vital signs monitoring system. The company has historically generated all or a significant portion of its revenue from a single product, the MRI-compatible IV infusion pump. While the company recently received FDA clearance for its next-generation MRidium® 3870 infusion pump, its overall product range remains limited. This heavy reliance on a narrow set of products makes the company vulnerable to market acceptance, technological obsolescence, or issues specific to these products.
2. Regulatory Risks: As a medical device company, IRadimed operates in a highly regulated environment, primarily by the U.S. Food and Drug Administration (FDA). The company has faced past regulatory challenges, including a warning letter in 2014 concerning a software update for its IV pump, which led to a temporary halt in domestic shipments. Although IRadimed has since achieved FDA clearances for new products, regulatory hurdles, the ability to secure future 510(k) clearances for new products or modifications, and the ever-present risk of product recalls, adverse event reporting, or other regulatory actions remain significant concerns.
3. Competition: While IRadimed currently holds a leading or "near-monopoly" position in its specialized niche of MRI-compatible infusion pumps, it faces competition from other medical equipment companies. The medical equipment industry is highly competitive, and there is a risk that larger, more established medical device manufacturers could enter the MRI-compatible device market, or that new technologies could emerge that render IRadimed's current systems less competitive or even obsolete.

AI Analysis | Feedback

AI Analysis | Feedback

IRadimed (IRMD) operates in two primary addressable markets: MRI-compatible IV infusion pump systems and MRI-compatible patient vital signs monitoring systems.

MRI-Compatible IV Infusion Pump Systems

• Globally, the market for MRI-compatible IV infusion pump systems is estimated to be valued at approximately USD 322.5 million in 2025 and is projected to reach USD 742.9 million by 2035, growing at a compound annual growth rate (CAGR) of 8.7%. Other estimates place the global market size at USD 258.0 million in 2023, expected to reach USD 663.2 million by 2033 with a CAGR of 9.9%. Another report indicates a global market size of approximately USD 450 million in 2024, projected to reach USD 850 million by 2033 at a CAGR of around 7.0%.
• In North America, this market is a significant segment, accounting for over 40% of the market share in 2025. North America held approximately 52.3% market share, with a revenue of USD 134.9 million in 2023. The region retained 44.84% of the market size in 2024.

MRI-Compatible Patient Vital Signs Monitoring Systems

• The global market for MRI-compatible patient monitoring systems is projected to grow from USD 4.3 billion in 2025 to USD 6.4 billion by 2035, at a CAGR of 4.0%. This market was valued at USD 3,929.6 million in 2023 and is projected to reach USD 5,418.5 million by 2031, with a CAGR of 4.9%. The broader global MRI monitoring devices market is anticipated to be valued at US$4.2 billion in 2025 and reach US$5.6 billion by 2032, with a CAGR of 4.2%.
• North America is expected to dominate the MRI-compatible patient monitoring systems market, holding a 35.2% market share in 2025. It is considered the largest market for these systems and is expected to account for a 40% share of the MRI monitoring devices market in 2025.

AI Analysis | Feedback

iRadimed (IRMD) is expected to experience future revenue growth over the next 2-3 years, driven by several key factors:

1. Launch and Expansion of the New 3870 MRI IV Pump System: The commercial launch of the next-generation 3870 MRI-compatible IV infusion pump system is a significant driver. Limited commercial shipments are anticipated in December 2025, with a full U.S. rollout expected in the first quarter of 2026. The company expects revenue from this new product to ramp significantly in the second half of 2026. This new pump is projected to drive penetration into new market opportunities and accelerate the replacement of over 6,300 older 3860 pump units in the U.S. that are more than five years old, with sales targeted at over 2,000 3870 pump channels annually. Furthermore, the 3870 pump system is expected to command a 10% to 14% higher average selling price than its predecessor, contributing directly to revenue growth.
2. Continued Growth in MRI Patient Monitor Sales: iRadimed has seen consistent growth in its MRI patient monitor sales, with shipments increasing by 16% year-over-year in Q3 2025. This segment is a strategic emphasis for the company and is expected to help maintain quarterly revenue through the first half of 2026.
3. Increased Production Capacity from the New Orlando Manufacturing Facility: The company's transition to its new, larger manufacturing facility in Orlando is now fully operational and is critical for meeting accelerating demand. This expanded capacity is projected to support quarterly revenues of up to $50 million, addressing the current all-time high backlog for pump and monitor products.
4. Recurring Revenue from Disposables: Disposables, which are single-use accessories, represent a critical and growing recurring revenue stream for iRadimed. This segment saw a 12% increase in Q3 2025 and is expected to continue supporting overall revenue as the installed base of the company's MRI-compatible IV infusion pumps and monitors expands.
5. Sustained Demand for Existing 3860 MRI IV Pump Systems: Even with the upcoming launch of the 3870, the existing 3860 MRI IV pump system continues to demonstrate strong performance, with its shipments growing 20% year-over-year in Q3 2025. This ongoing strong demand for the current generation product will contribute to revenue growth, particularly until the 3870 fully ramps up.

AI Analysis | Feedback

Capital Expenditures

• iRadimed completed the construction of its new facility in Orlando, Florida, in early July 2025, with a total cost of approximately $13.3 million.
• Capital expenditures for the nine months ended September 30, 2025, were $8.0 million, compared to $5.8 million for the same period in 2024.
• The primary focus of recent capital expenditures has been the new facility and investments related to the next-generation 3870 MRI-compatible IV infusion pump system, with limited commercial shipments expected in December 2025 and full U.S. rollout in Q1 2026.