ReadiMask gets independent MR Safe determination for MRI use

Global Safety First says MED Institute independently evaluated the ReadiMask Strapless Respirator under ASTM F2503-26 and determined it can be labeled MR Safe. The finding gives patients and MRI facilities documentation supporting use of the respirator during scans, including models with the optional Integrated Eye Shield.

Why it matters: - Patients who depend on a respirator may now have independent documentation supporting use of ReadiMask during MRI exams. - MRI facilities get a standardized MR safety determination they can review instead of relying on informal product descriptions. - The MR Safe label means the item poses no known hazards from exposure to any MRI environment and has no MRI-related conditions or restrictions.

What happened: - Global Safety First announced that MED Institute completed an independent technical evaluation of the ReadiMask Strapless Respirator under ASTM F2503-26. - MED Institute determined the evaluated ReadiMask products meet the definition of MR Safe under ASTM F2503-26 and can be labeled MR Safe. - The determination covers ReadiMask with and without the optional attached Integrated Eye Shield. - The announcement was dated October 7, 2026, from Sea Girt, New Jersey.

The details: - FDA guidance recommends the ASTM F2503 framework for MR safety labeling, including the terms MR Safe, MR Conditional and MR Unsafe. - ReadiMask customers have reported wearing the respirator during hundreds of MRI exams. - Some facilities have questioned or resisted use of the product without independent MR safety documentation. - Global Safety First commissioned MED Institute to provide technical documentation for patients and MRI professionals. - In a review of publicly available U.S. product information, ReadiMask was among a relatively small number of masks and respirators with detailed MRI-specific safety documentation available for review. - ReadiMask 365 was named one of only two winners of the U.S. government’s Mask Innovation Challenge, sponsored by BARDA. - The competition drew nearly 1,500 submissions from startups, universities and major companies. - ReadiMask was evaluated by NIOSH and NIST for filtration efficiency, breathability, comfort, fit and function. - The U.S. Army separately evaluated ReadiMask for filtration efficiency and breathing resistance using NIOSH test procedures. - ReadiMask uses a medical-grade adhesive around its perimeter to seal directly to the skin. - The respirator is designed to conform to individual facial contours across a wide range of face shapes and sizes. - ReadiMask has no metal nose wire, staples, clips or fasteners. - Global Safety First says that construction makes ReadiMask well suited to the MR environment and usable during MRI exams without restrictions based on scanner type or magnetic field strength. - John Schwind, inventor and CEO of Global Safety First, said the independent evaluation under ASTM F2503-26 confirms what the design means in the MRI room. - David Gross, PhD, PE, vice president of MED Institute, said clear documentation helps MRI professionals make informed decisions and that MED Institute was pleased to provide objective technical support for MR Safe labeling.

Between the lines: - The documentation appears aimed at removing a practical barrier, not changing the respirator’s design. - The key issue is trust inside the MRI workflow, where safety labeling can determine whether a patient can keep respiratory protection on during a scan. - Independent testing matters here because MRI staff often need a clear, standardized designation before allowing an item into the scanner room.

What's next: - MRI technologists, MR Safety Officers and procurement staff can review the MED Institute technical memorandum and one-page MR Safe determination at ReadiMask’s MRI page. - Global Safety First also points users to media resources and high-resolution images and media inquiries. - The company says the documentation is intended to support patient access to the respirator during MRI exams.

The bottom line: - ReadiMask now has independent MR Safe documentation under ASTM F2503-26, giving patients and MRI facilities a clearer basis for allowing the respirator in the MRI room.