KORU Medical Secures EU MDR Certification for Freedom60 Infusion Pump

KORU Medical Systems, Inc. KRMD recently announced that its Freedom60 Infusion Pump — along with an adapter designed for 50 mL prefilled syringes — has secured certification under the European Union Medical Devices Regulation. This approval paves the way for broader commercialization across the European Union, strengthening access to innovative home infusion solutions.

Per management, the EU MDR certification for the Freedom60 Infusion Pump represents a milestone in expanding access to more streamlined and patient-centered SCIg delivery across Europe. As prefilled syringes gain wider adoption, patients seek solutions that simplify treatment and integrate seamlessly into everyday life. The Freedom60 and FreedomEDGE Infusion System are built to address this demand by making therapy more efficient while preserving the reliability trusted by both clinicians and patients.

KRMD Stock Trend Following the News

Shares of KORU Medical have gained 0.2% since the announcement on Friday. Over the past six months, shares of the company have climbed 8.3% against the industry’s 37.6% decline. Meanwhile, the S&P 500 has risen 1.3% during the same timeframe.

In the long run, as the adoption of subcutaneous immunoglobulin (SCIg) therapy continues to grow, innovations like KRMD’s infusion systems play a crucial role in improving patient outcomes and quality of life. The EU MDR certification strengthens the company’s competitive position by unlocking a large and regulated market while validating the safety and efficacy of its infusion platforms. The approval also provides multi-year growth visibility through increased adoption of its systems, recurring consumables demand and deeper penetration into the home infusion segment, supporting sustained revenue expansion.

KRMD currently has a market capitalization of $198.46 million.

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More on the News

The Freedom60 Infusion Pump is engineered to support 50 mL prefilled syringes, while the FreedomEDGE Infusion System complements it by accommodating 20 mL formats. Together, these systems provide flexibility across different dosing requirements while maintaining a consistent and user-friendly experience for both clinicians and patients.

The EU MDR certification for both the Freedom60 Infusion Pump and the FreedomEDGE Infusion System broadens the availability of a solution built to support the increasing adoption of prefilled syringes in SCIg therapy while also making the home infusion process more convenient for patients.

The growing availability of prefilled syringe formats marks a significant advancement in the evolution of SCIg therapy. Research indicates that prefilled syringes are gaining traction as they reduce preparation steps compared to traditional vial-based methods, minimize medication handling and help lower the overall treatment burden. As a result, patients gain greater confidence and independence when managing their therapy at home.

Industry Prospects Favoring the Market

Going by data provided by Precedence Research, the home infusion therapy market is valued at $90.65 billion in 2026 and is expected to witness a CAGR of 8.04% through 2035.

Factors like the increasing prevalence of chronic disease, the increasing spending on healthcare, the rising demand for home-based healthcare solutions, and the healthcare infrastructure and policy support are driving market growth.

Other News

In January, KORU Medical announced that the FDA had cleared its FreedomEDGE Infusion System for delivering RYSTIGGO, a therapy commercialized by UCB. The updated label allows administration by healthcare professionals, improving patient access and flexibility. RYSTIGGO is a biologic treatment for adults with generalized myasthenia gravis, a rare chronic autoimmune condition that disrupts communication between nerves and muscles.

In December, KORU Medical announced it had submitted a 510(k) premarket notification to the FDA seeking clearance to use its FreedomEDGE Infusion System for subcutaneous delivery of PHESGO, a co-formulated therapy for HER2-positive breast cancer.

KORU Medical Systems, Inc. Price

KORU Medical Systems, Inc. price | KORU Medical Systems, Inc. Quote

KRMD’s Zacks Rank & Other Key Picks

Currently, KRMD has a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medical space are Phibro Animal Health PAHC, Intuitive Surgical ISRG and Cardinal Health CAH.

Phibro Animal Health, currently sporting a Zacks Rank #1 (Strong Buy), reported second-quarter fiscal 2026 adjusted EPS of 87 cents, which surpassed the Zacks Consensus Estimate by 27.1%. Revenues of $373.9 million beat the Zacks Consensus Estimate by 4.7%. You can see the complete list of today’s Zacks #1 Rank stocks here.

PAHC has an estimated long-term earnings growth rate of 21.5% compared with the industry’s 12.5% rise. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 20.1%.

Intuitive Surgical, carrying a Zacks Rank #2 at present, reported fourth-quarter 2025 adjusted earnings per share (EPS) of $2.53, beating the Zacks Consensus Estimate by 12.4%. Revenues of $2.87 billion surpassed the Zacks Consensus Estimate by 4.7%.

ISRG has an estimated long-term earnings growth rate of 15.7% compared with the industry’s 13.6% rise. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 13.2%.

Cardinal Health, currently carrying a Zacks Rank #2, reported a second-quarter fiscal 2026 adjusted EPS of $2.63, which surpassed the Zacks Consensus Estimate by 10%. Revenues of $65.6 billion beat the Zacks Consensus Estimate by 0.9%.

CAH has an estimated long-term earnings growth rate of 15% compared with the industry’s 9.2% rise. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 9.3%.

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