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Today marks a truly special moment for all of us at Topia MedTech. We’re proud to share that Alzevita has officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under clearance number K252670.
This milestone is the result of months of dedication, collaboration, and belief in what we’re building. The FDA’s decision recognizes Alzevita as an Automated Radiological Image Processing Software (21 CFR 892.2050), confirming that our platform meets rigorous standards for safety and performance and is substantially equivalent to existing cleared technologies.
But beyond regulatory language, this clearance represents something much bigger. Alzevita was created to help clinicians and researchers better understand brain MRI data—using AI to provide quantitative, longitudinal insights into how the brain changes over time. With this clearance, radiologists, neurologists, and neuroscientists can confidently use Alzevita as part of their imaging workflow to gain more objective, consistent insights from serial MRI scans.
This achievement belongs to every team member who contributed—our engineers who refined every algorithm, our clinical and regulatory experts who guided the validation process, and our quality teams who ensured we met the highest standards. It’s a testament to what’s possible when passion meets purpose.
For Alzevita and Topia MedTech, FDA clearance is not just a checkpoint—it’s a foundation for what comes next. We’re excited to continue improving our platform, expanding its capabilities, and supporting clinicians with tools that make a real difference in brain health.
Thank you to everyone who made this milestone possible. Here’s to the next chapter.
For official FDA details, please visit:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k252670