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WINTER SPRINGS, Fla. - Iradimed Corporation (NASDAQ: IRMD), known for its MRI-compatible medical devices and maintaining a robust 76.91% gross profit margin, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MRidium® 3870 IV Infusion Pump System. This latest innovation from Iradimed, which has achieved an "GREAT" financial health rating according to InvestingPro, is designed to enhance patient safety and improve workflow efficiency during MRI procedures.
The MRidium® 3870, which builds on the company’s first-generation device introduced in 2005, is the only non-magnetic MRI infusion pump device on the market, according to the company’s statement. The system features a non-magnetic ultrasonic pump motor and non-ferrous components, which are essential for safe operation within high-magnetic-field environments such as MRI rooms. The company’s focus on innovative medical devices has contributed to its impressive 11.04% revenue growth over the last twelve months.
This next-generation system also introduces a user-friendly graphical touchscreen interface and advanced safety features. The 3870 can be used independently or linked with additional pumps to form a four-channel system, making it versatile for various critical care situations. Moreover, it includes a modern drug library solution that supports multiple patient care area drug listings. With a strong current ratio of 8.87, InvestingPro data shows the company is well-positioned to support its product development and market expansion initiatives.
Roger Susi, President and CEO of Iradimed, expressed his enthusiasm about the FDA clearance, emphasizing the company’s commitment to advancing MRI-compatible medical technology. He noted that the MRidium® 3870 allows clinicians to deliver critical IV fluids and medications safely and predictably in MRI settings.
Iradimed plans to strategically roll out the FDA-cleared MRidium® 3870 infusion pump, with initial deployments at select healthcare facilities in the fourth quarter of 2025. The company expects to ramp up to full commercial distribution throughout 2026.
The statement from Iradimed also highlighted the importance of MRI-compatible devices, as standard infusion pumps with magnetic and electronic components can interfere with MRI scans and pose risks to patients. The MRidium® 3870 is designed to mitigate these risks, providing a seamless and safe fluid delivery system for patients undergoing MRI procedures.
This news is based on a press release statement from Iradimed Corporation, which has established itself as a leader in the development of MRI-compatible medical devices since its inception.
In other recent news, Iradimed Co reported strong financial results for the first quarter of 2025, surpassing analyst expectations. The company achieved an earnings per share (EPS) of $0.42, slightly above the forecasted $0.41, and revenue of $19.5 million, exceeding the anticipated $19.13 million. This marks the 15th consecutive quarter of record revenues for Iradimed Co, with a notable 11% year-over-year increase in revenue, primarily driven by domestic sales. Additionally, domestic revenue surged by 19%, while international sales saw a 15% decline. The company’s gross margin was reported at 76.1%, demonstrating effective cost management.
Looking ahead, Iradimed Co projects second-quarter 2025 revenue between $19.7 million and $19.9 million, with GAAP EPS expected to range from $0.37 to $0.40. For the full year of 2025, the company forecasts revenue between $78 million and $82 million and GAAP EPS between $1.55 and $1.65. Despite potential risks, including possible FDA clearance delays for the new 3,870 MRIV pump and declining international sales, the company remains optimistic. Iradimed Co’s CEO, Roger Souci, expressed confidence in their operational plans and highlighted the company’s continued positive momentum.
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