Biomerica, Inc. announced that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the European Union’s new In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746). This certification marks a significant milestone for Biomerica, underscoring the company’s commitment to expanding its products in international markets. The IVDR framework introduces rigorous new requirements for in-vitro diagnostics across Europe.
The newly approved food intolerance products are designed to address the growing need for non-invasive and personalized therapies to manage Crohn’s Disease and Ulcerative Colitis, conditions affecting millions worldwide. Biomerica’s products successfully met the General Safety and Performance Requirements of IVDR, demonstrating the company’s ability to deliver innovative solutions. This certification can also facilitate market access in other international markets with stringent regulatory approval processes.
The global Ulcerative Colitis market is expected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, with the Crohn's Disease therapeutics market estimated at $13.2 billion in 2023. These figures highlight the substantial and growing demand for effective, non-invasive solutions. CEO Zack Irani stated that this certification not only validates the safety and effectiveness of their products but also positions Biomerica to expand sales in the European market.
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