IRADIMED CORPORATION (IRadimed) develops, manufactures, markets and distributes Magnetic Resonance Imaging (‘MRI’) compatible medical devices and related accessories, disposables and services relating to them.
MRidium 3860+ MRI Compatible IV Infusion Pump System
The company is 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 gausses. Th...
IRADIMED CORPORATION (IRadimed) develops, manufactures, markets and distributes Magnetic Resonance Imaging (‘MRI’) compatible medical devices and related accessories, disposables and services relating to them.
MRidium 3860+ MRI Compatible IV Infusion Pump System
The company is 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 gausses. The company was 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. The company’s 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. The company’s 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 Monitoring System
The company’s 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gausses, which means it can operate virtually anywhere in the MRI scanner room. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless Electrocardiogram (‘ECG’) with dynamic gradient filtering; wireless blood oxygen saturation monitoring (‘SpO2’) using Masimo algorithms; non-magnetic respiratory carbon dioxide (‘CO2’); invasive and non-invasive blood pressure; patient temperature; and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.
The company sells its products primarily to hospitals and acute care facilities, both in the United States and internationally. The company employs a direct sales strategy in the United States, and as of December 31, 2024, its direct sales force consisted of 27 field sales representatives, supported by 4 regional sales directors, and supplemented by 10 clinical application specialists. Internationally, the company markets its products in approximately 80 countries using independent distributors.
As of December 31, 2024, the company has sold approximately 7,832 MRI compatible IV infusion pump systems and approximately 2,679 of its 3880 MRI compatible patient vital signs monitoring systems.
The company generates revenue from the sale of MRI compatible medical devices and related accessories, extended warranty agreements, services related to maintaining its products, and the sale of disposable products used with its devices.
Strategy
The company’s strategies include driving market awareness of the company’s MRI compatible IV infusion pump and the safety risks associated with using conventional IV pumps with long IV lines; driving market awareness of the company’s MRI compatible patient vital signs monitoring system; continuing to innovate with MRI compatible patient care products; when reasonably available, acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate the company’s product development and leverage the company’s existing sales organization; continued development of the company’s MRI-focused U.S. direct sales force and the company’s international sales efforts; supporting commercial efforts with evidence-based information; and providing best in class customer service and user experience.
Products
Typical MRI Scanner Room
The company’s 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI. Additionally, the company’s MRidium MRI compatible IV infusion pump is the only pump on the market approved to operate safely and reliably near the patient.
The company offers three primary products for use in the scanner room: its MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets, its 3880 MRI compatible patient vital signs monitoring system with associated disposable products, and its 3600 FMD1 with Remote Alarm Logging Unit (RALU) ferromagnetic detection device.
MRidium MRI Compatible IV Infusion Pump System
The patented MRidium MRI compatible IV infusion pump system is based upon a non-magnetic, ultrasonic motor and other uniquely designed non-ferrous parts to provide accurate and dependable fluid delivery to patients undergoing an MRI procedure. The company’s MRidium MRI compatible IV infusion pump system has been designed to offer numerous advantages to hospitals, clinicians, and patients.
The company’s MRI compatible IV infusion pump system includes the 3860+ MRI compatible IV infusion pump, proprietary single-use IV tubing sets, a non-magnetic pole and a lithium battery. In addition, the company offers optional upgrade systems, including the 3861 Side Car, 3865 Remote Display/Control, DERS and an SpO2 monitor.
MRidium 3860+ MRI Compatible IV Infusion Pump
The MRidium 3860+ MRI compatible IV infusion pump was introduced in 2009 and improved upon the performance and features of the company’s first generation MRidium 3850 MRI compatible IV infusion pump. The MRidium 3860+ pump system can operate dependably in the presence of 0.2T to 3T magnets and is fully operational up to the 10,000 gauss-line. This means the company’s MRidium 3860+ is highly versatile and can operate virtually anywhere in the MRI scanner room, including close to the MRI scanner. The MRidium 3860+ MRI compatible IV infusion pump system has a 10-key numeric input keypad making the company’s system easy to accurately program and operate. The company’s pumping range of 0.1 mL per hour to 1,400 mL per hour provides a broad range of fluid flow control. The company’s broad range of infusion rates support differing patient needs, including low levels for pediatric sedation, mid-levels for continued IV infusion of medications to critically ill patients and high levels in the event of emergency situations. The company’s MRidium 3860+ MRI compatible IV infusion pump system offers a dose rate calculator, bolus dose programming, full alarm settings, and a rechargeable battery with a 12-hour life.
MRidium 3860+ IV Tubing Sets
The MRidium 3860+ MRI compatible IV infusion pump system utilizes proprietary fluid delivery tubing sets, each known as an ‘IV tubing set.’ Each use of the company’s MRI compatible IV infusion pump requires a disposable IV tubing set. The company offers a variety of IV tubing sets for varying infusion scenarios, and these include its standard ‘spike’ infusion set, syringe adapter infusion set, and extension infusion set. Each of the company’s IV tubing sets is latex-free and DEHP-free.
MRidium 1056 Standard Infusion Set: The company’s standard ‘spike’ infusion set features the ability to accurately deliver liquids from either a bottle or IV bag. The 1056 standard infusion set contains two needle-free injection ports and is typically used when starting a new infusion from a bottle or bag.
MRidium 1057 Syringe Adapter Infusion Set: The company’s syringe adapter IV set enables users to provide accurate delivery of IV fluids directly from standard syringes. The 1057 vented syringe adapter set benefits from a low priming volume of 4 ml, which minimizes inefficient waste of medication. This product is most used for cardiac medications, anesthesia, and pediatric drug delivery.
MRidium 1058 Extension Infusion Set: The company’s extension infusion set allows users to transfer a patient on a standard infusion pump to the company’s MRI compatible IV infusion pump. The user simply disconnects the existing IV tubing at the patient site and primes and connects the MRidium extension set to the existing IV tubing. Once removed from the conventional infusion pump and connected to the company’s MRidium MRI compatible IV infusion pump, the user can program the pump and begin the infusion. The 1058 extension set includes one needle-free injection port and is typically used to provide uninterrupted critical medications to a severely ill patient during an MRI procedure.
MR IV Pole
The company offers a fully functional and weighted non-magnetic IV pole that is designed for mobility within the hospital and the MRI scanner room. The IV pole can support two MRidium 3860+ MRI compatible IV infusion pumps, each with a 3861 Side Car Pump Module. The IV pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport. The IV pole is equipped with four hooks for holding fluid bags.
Optional Features
The company’s 3860+ MRI compatible IV infusion pump system gives customers the ability to adapt their systems to meet their specific needs. In addition to the company’s standard product features, it also offers system upgrades which include a modular add-on second IV channel through the company’s 3861 Side Car, a wireless remote control/display, DERS and an imbedded SpO2 monitor. The company also offers rechargeable lithium polymer battery packs which has 12-hour life when not connected to an electrical outlet.
3861 Side Car Pump Module
The company’s Side Car Pump Module can be attached to its 3860+ MRidium MRI compatible IV infusion pump to provide a second channel for infusion delivery. This flexible option allows hospitals to convert their single-channel infusion pump into a dual-channel system designed to deliver both large and small volume fluids in the MRI scanner room. The side car is fully functional with the company’s 3865 MRidium Wireless Remote, allowing clinicians the ability to control both channels with one remote control unit outside of the MRI scanner room. The additional delivery line has all of the same features and benefits as the 3860+ MRidium MRI compatible IV infusion pump.
3865 MRidium Wireless Remote Display/Control
The company’s wireless remote display/control unit allows for complete control and monitoring of the MRidium MRI compatible IV infusion pump system from the control room (outside of the MRI scanner room). The 3865 MRidium Wireless Remote relays all commands via a single channel and displays information bi-directionally between the MRI compatible IV infusion pump and the remote display/control unit. Utilizing the same user interface and large bright display as the MRidium pump, the company’s wireless remote display/control unit permits clinicians to adjust all pump parameters, including SpO2 monitoring parameters, rates, dose, volume, pump run/stop, alarms (adjust or reset), as well as real-time titration. The company’s remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process. The company’s 3865 MRidium Wireless Remote also functions as a battery charger for its MRidium battery pack.
Dose Error Reduction System (‘DERS’)
The company’s DERS software for use with its MRidium 3860+ MRI compatible IV infusion pump system incorporates the latest dosing safety features for patients. The DERS system enables users to create a unique drug library and establish nominal values and limits for dose and concentration for specified infusion protocols. With DERS, patient safety and user convenience are supported by user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed). The dose applied via DERS is displayed and can be adjusted directly on the running screen at any time during the infusion. The memory card port allows for easy archiving and updating of the drug library.
SpO2 Monitoring with Sensor and Accessories
The company’s MRidium 3860+ MRI compatible IV infusion pump system also offers state-of-the-art Masimo SET SpO2 capability providing a unique ability to have SpO2 monitoring, and IV delivery combined in one unit. This feature offers users the ability to start sedations outside of the MRI scanner room, transport to the scanner, and then back to recovery without having to discontinue SpO2 monitoring of the patient. In addition, the company’s fiber optic MRI SpO2 sensor and accessories provide a safe connection between the patient and the company’s MRI compatible IV infusion pumps. This fiber optic based SpO2 sensor delivers outstanding performance while avoiding potentially hazardous heating or image artifact during MRI scans. The method of patient attachment uses a medical-grade silicone rubber sensor grip that allows easy and convenient attachment to the patient’s hand or foot, and accommodates pediatric, adult, and infant patients with various size grips.
The company’s MRidium 3860+ MRI compatible IV infusion pump system and its customizable features comprehensively and uniquely address the needs of MRI departments within hospitals and other medical facilities.
MRI Compatible Patient Vital Signs Monitoring System
The company’s 3880 Monitor has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The 3880 Monitor system is fully operational in magnetic fields up to 30,000 gausses, which means it can operate virtually anywhere in the MRI scanner room.
The company’s 3880 Monitor has a compact, lightweight design allowing it to travel with the patient from the critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units.
The basic configuration of the 3880 Monitor includes wireless ECG with dynamic gradient filtering, wireless SpO2 using Masimo algorithms, and non-invasive blood pressure. Optional features include all or a combination of non-magnetic respiratory CO2; invasive blood pressure; patient temperature, and/or optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.
The MRI compatible patient vital signs monitoring system also includes an extended range remote tablet that allows for remote monitoring from outside the MRI scanner room; a base station control center that facilitates printing, wireless communications between the remote tablet and the monitor, and acts as a battery charger for the remote tablet; and wireless ECG, SpO2 and invasive blood pressure pods that facilitate the respective monitoring modalities.
IRadimed FMD1 with Remote Alarm Logging Unit (RALU)
The company’s 3600 ferromagnetic detection device, IRadimed FMD1 with Remote Alarm Logging Unit (RALU) is the first ferromagnetic detection device with TruSense threat qualification technology. The company’s patent pending TruSense technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status. with IRadimed’s expertise in Dynamic Signal Processing. This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise. The 3600 can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems.
The wireless touchscreen, RALU is unique in the industry and provides a full color visual representation of the MRI door and FMD status. When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation.
Intellectual Property
The company has 16 issued U.S. patents and 4 issued foreign patents with remaining lives of up to 17 years. The company also has a number of U.S. patent applications pending. These patents and patent applications relate to several of the company’s products, including the company’s MRI compatible IV infusion pump system and its components and the company’s MRI compatible patient vital signs monitoring system.
Sales and Marketing
The company sells its MRI compatible products through its direct sales force in the U.S. and independent distributors internationally. In the U.S., the company sells its products through 27 direct field sales representatives, 4 regional sales directors, and 10 clinical application specialists. The company has distribution agreements with independent distributors selling its products internationally. The company has developed an experienced team of international distributors that has a strong MRI/radiology product portfolio and focus. The company’s international distributors are managed by its international sales team.
The principal customers for the company's MRI compatible products include hospitals and acute care facilities. The key decision maker in a purchase varies depending on the hospital department making the purchase. The company serves these customers through its sales and service specialists and its specialists are well-positioned to build upon these customer relationships. The company communicates with its customers on a regular basis to understand potential issues or concerns, as well as to improve its products and services in response to their needs. Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair calls. The company has implemented various other programs that enable it to assess its customers’ needs, including surveys and visits to customer sites.
The company enters into agreements with Integrated Delivery Networks (‘IDNs’) and healthcare supply contracting companies, which are commonly referred to as Group Purchasing Organizations (‘GPOs’) in the U.S., which enables it to sell and distribute the company’s products to their member hospitals.
Seasonality
The company’s business is seasonal. Historically, the company’s third quarter (for the year ended December 31, 2024) bookings have typically been lower, compared to other fiscal quarters, principally because the fiscal quarter coincides with the summer vacation season in the northern hemisphere.
Research and Development
The company’s research and development expenses remain consistent at $2.8 million in 2024.
Regulatory Matters
The company’s medical device products are subject to extensive, complex and increasing oversight and regulation by the FDA, and other domestic and foreign governmental authorities.
All the company’s products and facilities and those of its suppliers are subject to drug and medical device laws and regulations promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including for example, Health Canada’s Health Products and Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency.
The development, manufacture, sale and distribution of the company’s medical device products are subject to comprehensive governmental regulation. Most notably, all the company’s medical devices sold in the United States are subject to the Food, Drug, and Cosmetic Act of 1938, as amended (‘FDC Act’), as implemented and enforced by the FDA. The FDA, and in some cases other government agencies, such as the U.S. Federal Communications Commission (‘FCC’), administer requirements covering the design, testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution, and post-market surveillance of the company’s products.
Unless an exemption applies, each medical device that the company markets must first receive either premarket notification clearance (by making what is commonly called ‘a 510(k) submission’) or premarket approval (by filing a premarket approval application (‘PMA’) from the FDA pursuant to the FDC Act). All the company’s regulated medical devices and related products that are available in the U.S. were originally cleared through the 510(k) process as required by the FDA.
The company’s global activities are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other countries’ anti-bribery laws that has been enacted in support of the Organization for Economic Cooperation and Development’s Anti-bribery Convention. The U.K. Bribery Act also prohibits commercial bribery and makes it a crime for a company to fail to prevent bribery.
The company’s policies mandate strict compliance with the anti-bribery laws.
The company is also subject to a variety of other laws, directives, and regulations in and outside of the U.S., including environmental laws and regulations; the safety and health laws of the U.S. Occupational Safety and Health Act, which sets forth requirements for workplace conditions; California’s Proposition 65, which sets forth a list of substances that are deemed by the State of California to pose a risk of carcinogenicity or birth defects; and various customs, export control, anti-boycott and trade embargo laws and regulations administered by U.S. and foreign government agencies, including the U.S. Customs and Border Protection, the Bureau of Industry and Security, the Department of Commerce and the Office of Foreign Assets Control Treasury Department, as well as others.
History
IRADIMED CORPORATION was incorporated in Oklahoma in 1992.
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