IRADIMED Amends 10-K for Certification Omission; 2024 Revenue Hits $73.2M

TL;DR

**IRMD's 10-K/A is a non-event for financials, just a compliance fix; their core business of MRI-compatible devices remains strong with a 30% operating margin.**

AI Summary

IRADIMED CORP (IRMD) filed a 10-K/A on September 3, 2025, to correct an omission of Section 906 certifications in Exhibit 32.1 from its original 10-K filed on March 6, 2025. This amendment does not reflect any new events or changes to the financial disclosures. For the fiscal year ended December 31, 2024, IRADIMED reported revenue of $73.2 million and income from operations of $22.0 million, achieving an operating profit margin of 30 percent. The company specializes in MRI-compatible medical devices, including the MRidium 3860+ MRI Compatible IV Infusion Pump System and the IRadimed 3880 MRI Compatible Patient Vital Signs Monitoring System. As of December 31, 2024, IRADIMED had sold approximately 7,832 IV infusion pump systems and 2,679 patient vital signs monitoring systems. The company also introduced its IRadimed FMD1 3600 ferromagnetic detection device in 2022. The filing highlights the company's direct sales strategy in the U.S. with 27 field sales representatives and international distribution across approximately 80 countries.

Why It Matters

This 10-K/A filing is a technical correction, specifically addressing the omission of Section 906 certifications, rather than a restatement of financial results. For investors, this indicates a regulatory compliance issue that has been addressed, but it doesn't alter the previously reported strong financial performance of $73.2 million in revenue and a 30% operating profit margin for 2024. Employees and customers are unaffected as the core business operations and product offerings, including the unique MRI-compatible IV infusion pump and vital signs monitor, remain unchanged. In a competitive landscape where patient safety in MRI environments is paramount, IRADIMED's specialized product line continues to offer a distinct advantage, reinforcing its market position.

Risk Assessment

Risk Level: low — The risk level is low because the 10-K/A filing explicitly states it is 'to correct an error... as a result of an omission of Section 906 certifications in Exhibit 32.1' and 'does not reflect any events that have occurred after the Form 10-K was filed.' This indicates a technical, administrative correction rather than a substantive financial or operational issue, posing minimal risk to investors.

Analyst Insight

Investors should view this 10-K/A as a routine regulatory compliance update, not a red flag. Given the strong 2024 financial performance with $73.2 million in revenue and a 30% operating profit margin, IRMD's core business appears robust. Maintain current positions, as this filing does not introduce new material risks or opportunities.

Financial Highlights

revenue

$73.2M

operating Margin

30%

Key Numbers

• $73.2M — Revenue (IRADIMED's revenue for fiscal year 2024)
• $22.0M — Income from operations (IRADIMED's income from operations for fiscal year 2024)
• 30% — Operating profit margin (IRADIMED's operating profit margin for fiscal year 2024)
• $349,253,009 — Aggregate market value of shares held by non-affiliates (As of June 30, 2024)
• 12,715,072 — Shares outstanding of common stock (As of February 28, 2025)
• 7,832 — MRI compatible IV infusion pump systems sold (As of December 31, 2024)
• 2,679 — 3880 MRI compatible patient vital signs monitoring systems sold (As of December 31, 2024)
• 27 — Field sales representatives (In the United States as of December 31, 2024)
• 80 — Countries (Where IRADIMED markets products internationally through distributors)
• 2024 — Fiscal year end (The period covered by the amended 10-K)

Key Players & Entities

• IRADIMED CORP (company) — Registrant filing the 10-K/A
• SEC (regulator) — Recipient of the 10-K/A filing
• Roger Susi (person) — Founder, President, CEO, and Chairman of IRADIMED CORP
• Nasdaq Global Market (regulator) — Exchange where IRMD common stock is listed
• Medtronic plc (company) — Former exclusive distribution partner for IRADIMED products
• Koninklijke Philips NV (company) — Acquirer of Invivo, a company founded by Roger Susi
• FDA (regulator) — Regulatory body for 510(k) clearance of medical devices
• Invivo Research Inc. (company) — Company founded by Roger Susi in 1979
• Mallinckrodt/Tyco Healthcare (company) — Former exclusive distribution partner for IRADIMED products

FAQ

Risk Factors

• FDA Approval and Compliance [high — regulatory]: The company's medical devices require stringent FDA approval and ongoing compliance with regulations. Failure to maintain these approvals or adhere to evolving regulatory standards could lead to product recalls, market withdrawal, or significant penalties, impacting revenue and operations.
• Competition and Market Adoption [medium — market]: While IRadimed is a pioneer in MRI-compatible devices, the market could see new entrants or existing competitors developing similar technologies. The company's success depends on continued market adoption of its specialized products and its ability to differentiate from potential competitors.
• Supply Chain and Manufacturing [medium — operational]: Reliance on specialized non-magnetic components and manufacturing processes could expose IRadimed to supply chain disruptions or quality control issues. Any interruption in the supply of critical components or manufacturing defects could impact production and delivery schedules.
• Dependence on Key Products [medium — financial]: The company's revenue is significantly driven by its MRidium IV infusion pump systems and 3880 vital signs monitoring systems. A decline in demand for these core products or issues with their performance could materially affect financial results.
• International Distribution Challenges [medium — market]: IRadimed relies on distributors in approximately 80 countries. Managing these international relationships, ensuring compliance with local regulations, and navigating varying market conditions present operational and financial risks.
• Cybersecurity Risks [medium — operational]: As a manufacturer of medical devices, IRadimed faces cybersecurity risks related to its products and internal systems. A breach could compromise patient data, disrupt operations, and damage the company's reputation.

Industry Context

IRadimed operates in the specialized medical device market, focusing on MRI-compatible equipment. This niche requires significant R&D investment and adherence to strict regulatory standards. The company competes by offering unique, patented solutions that address critical safety and operational needs within MRI suites, a segment where standard medical devices cannot function.

Regulatory Implications

The company's reliance on FDA approval for its devices means that any changes in regulatory requirements or enforcement could impact its product lifecycle and market access. Maintaining compliance with evolving medical device regulations is a continuous operational necessity.

What Investors Should Do

1. Monitor competitive landscape for new MRI-compatible device entrants.
2. Review future filings for updates on product development and international sales performance.
3. Assess the impact of any potential changes in FDA regulations on medical device manufacturers.

Key Dates

• 2025-03-06: Original 10-K filing for fiscal year ended December 31, 2024 — Initial disclosure of the company's annual financial performance and operational details for the fiscal year 2024.
• 2025-09-03: 10-K/A filing (Amendment No. 1) — Correction of an omission regarding Section 906 certifications (Exhibit 32.1), without altering the financial or operational disclosures from the original filing.
• 2024-12-31: Fiscal year end — The period for which the financial and operational data in the 10-K/A filing pertains, including sales figures for key products.
• 2024-06-30: Measurement date for aggregate market value of shares held by non-affiliates — Provides a snapshot of the company's market capitalization as of this date, relevant for understanding investor valuation.

Glossary

MRI Compatible

Medical devices designed to operate safely and effectively within the strong magnetic fields generated by Magnetic Resonance Imaging (MRI) scanners. (This is the core technology and market differentiator for IRadimed's products, enabling critical patient monitoring and treatment during MRI procedures.)

IV Infusion Pump System

A medical device used to deliver intravenous fluids, medications, or nutrients to a patient's body at a controlled rate. (IRadimed's MRidium 3860+ is a key product in this category, specifically designed for MRI environments.)

Patient Vital Signs Monitoring System

A device that tracks and displays a patient's physiological indicators such as heart rate, blood pressure, and oxygen saturation. (IRadimed's 3880 system is designed for use during MRI scans, ensuring continuous monitoring for critically ill patients.)

Gauss

A unit of magnetic flux density, used to measure the strength of a magnetic field. (The filing specifies the gauss ratings (e.g., 10,000 gauss for the pump, 30,000 gauss for the monitor) that the devices can withstand, indicating their robustness in MRI environments.)

Ferromagnetic Detection Device

A device used to detect the presence of ferromagnetic materials, which can pose a significant safety hazard in MRI environments. (IRadimed's FMD1 3600 is a product designed to enhance safety by identifying potentially dangerous metallic objects before they enter the MRI scanner.)

Section 906 Certifications

Certifications required by the Sarbanes-Oxley Act of 2002, where the CEO and CFO of a company must certify that a periodic report complies with SEC disclosure requirements and fairly presents the financial condition and results of operations. (The 10-K/A filing was specifically to correct the omission of these certifications from the original 10-K, highlighting a procedural compliance issue.)

Year-Over-Year Comparison

This 10-K/A filing is an amendment to correct a procedural omission of Section 906 certifications and does not introduce new financial or operational information. Therefore, a direct comparison of key metrics like revenue growth, margin changes, or new risks against a prior year's filing is not applicable based on this amendment alone. The core financial data for fiscal year 2024, such as $73.2 million in revenue and a 30% operating margin, remains consistent with the original filing.

Key Financial Figures

• $0.0001 — h registered: Common stock, par value $0.0001 IRMD Nasdaq Global Market SECURIT
• $73.2 million — s. In fiscal year 2024, our revenue was $73.2 million and our income from operations was $22.
• $22.0 million — lion and our income from operations was $22.0 million representing an operating profit margin

Filing Documents

• irmd-20241231x10ka.htm (10-K/A) — 1682KB
• irmd-20241231xex10d8.htm (EX-10.8) — 16KB
• irmd-20241231xex10d9.htm (EX-10.9) — 18KB
• irmd-20241231xex10d10.htm (EX-10.10) — 16KB
• irmd-20241231xex10d11.htm (EX-10.11) — 16KB
• irmd-20241231xex10d12.htm (EX-10.12) — 52KB
• irmd-20241231xex19d1.htm (EX-19.1) — 133KB
• irmd-20241231xex23d1.htm (EX-23.1) — 2KB
• irmd-20241231xex31d1.htm (EX-31.1) — 12KB
• irmd-20241231xex31d2.htm (EX-31.2) — 12KB
• irmd-20241231xex32d1.htm (EX-32.1) — 10KB
• irmd-20241231x10ka001.jpg (GRAPHIC) — 99KB
• irmd-20241231x10ka003.jpg (GRAPHIC) — 47KB
• 0001558370-25-011853.txt ( ) — 7835KB
• irmd-20241231.xsd (EX-101.SCH) — 44KB
• irmd-20241231_cal.xml (EX-101.CAL) — 63KB
• irmd-20241231_def.xml (EX-101.DEF) — 169KB
• irmd-20241231_lab.xml (EX-101.LAB) — 464KB
• irmd-20241231_pre.xml (EX-101.PRE) — 350KB
• irmd-20241231x10ka_htm.xml (XML) — 1109KB

BUSINESS

BUSINESS 1 ITEM 1A.

RISK FACTORS

RISK FACTORS 20 ITEM 1B. UNRESOLVED STAFF COMMENTS 38 ITEM 1C. CYBERSECURITY 38 ITEM 2.

PROPERTIES

PROPERTIES 39 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 39 ITEM 4. MINE SAFETY DISCLOSURES 39 PART II 40 ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 40 ITEM 6. [RESERVED] 41 ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 42 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 48 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 48 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 48 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 49 ITEM 9B. OTHER INFORMATION 50 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 50 PART III 50 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 50 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 50 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 50 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 50 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 50 PART IV 51 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 51 ITEM 16. FORM 10-K SUMMARY 51 EXHIBIT INDEX 51

SIGNATURES

SIGNATURES 53 INDEX TO FINANCIAL STATEMENTS F-1 ii Table of Contents CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Form 10-K" or "Annual Report") within the meaning under Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements include, but are not limited to, statements regarding our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. The words "may," "will," "anticipate," "believe," "expect," "continue," "could," "estimate," "future," "expect," "intends," "might," "plan," "possible," "potential," "aim," "strive," "predict," "project," "should," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this Annual Report include, among other things, statements about: our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration ("FDA") or other regulatory bodies resulting in favorable outcomes, additional actions by or requests from the FDA, including a request to cease domestic distribution of products, or other regulatory bodies and unanticipated costs or delays associated with the resolution of these matters; the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities; unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory

BUSINESS

ITEM 1. BUSINESS Overview IRADIMED CORPORATION ("IRadimed", the "Company," "we," "us," "our" or similar terms) develops, manufactures, markets and distributes Magnetic Resonance Imaging ("MRI") compatible medical devices and related accessories, disposables and services relating to them. We were originally incorporated in Oklahoma under the name IRI Development, Inc. in 1992, and we merged our Oklahoma corporation into the newly formed Delaware corporation in April 2014. MRidium 3860+ MRI Compatible IV Infusion Pump System We are the only known provider of a non-magnetic intravenous ("IV") infusion pump system that is specifically designed to be safe for use during MRI procedures and operates dependably in magnetic fields up to 10,000 gauss. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated to remain immobile during an MRI scan. Each IV infusion pump system consists of an MRidium MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories. IRadimed 3880 MRI Compatible Patient Vital Signs Monit

View Full Filing

View this 10-K/A filing on SEC EDGAR