Lineus Medical Obtains CE Mark for Flagship Product SafeBreak Vascular

FAYETTEVILLE, Ark. - Sept. 30, 2025 - PRLog -- Lineus Medical has obtained CE Mark certification for its flagship product, SafeBreak® Vascular, the only breakaway device for IV lines clinically proven to reduce multiple IV complications.¹ With this certification, SafeBreak Vascular is now cleared for use across the European Union. This approval expands SafeBreak Vascular's clearance from 5 countries to 32, spanning across more than three continents. Lineus Medical is actively partnering with distributors across Europe to expand hospital access to SafeBreak worldwide.

SafeBreak Vascular is a break-away device for IV lines clinically proven to reduce IV complications¹. When a harmful force is placed on the line, SafeBreak intentionally separates to remove the damaging force and protect the patient's IV. When SafeBreak separates, valves on both ends of the device close preventing medicine spills from the pump and blood loss from the patient. To replace SafeBreak, each component is unthreaded from the line, a new sterile SafeBreak is installed, and the patent's infusion is restarted. Patients avoid additional needlesticks, nurses save time, and hospitals save money¹.

"Earning the CE Mark is a major milestone in our company's journey," says Vance Clement, CEO of Lineus Medical. "It reflects our commitment to remove the pains associated with IV lines and make SafeBreak Vascular the standard of care worldwide.  Our goal is to be the leading company in this market segment in both science and sales.  This clearance affirms that position and makes SafeBreak the first break-away device to have clearance in Asia, Europe, and North America."

Larry Hayes, VP of Sales comments, "With CE Mark approval, we are opening the door to new distribution partnerships across Europe. This certification allows SafeBreak Vascular to reach more hospitals and healthcare systems, accelerating our global commercialization strategy and expanding our global footprint."

"Achieving CE Mark certification is a testament to the quality and reliability of both our product and our manufacturing processes," said Will Armstrong, COO. "It reflects the strength of our team and our commitment to maintaining the highest standards."

About Lineus Medical
Lineus Medical is the developer of SafeBreak Vascular, a breakaway technology proven to reduce IV restarts and IV complications.¹ Our mission is to remove the pains associated with medical lines. More information about Lineus Medical can be found at www.lineusmed.com. Follow Lineus Medical on LinkedIn, Facebook, and Instagram.

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