The US FDA has granted 510(k) clearance to Methinks AI’s NCCT Stroke software, a milestone for stroke care and an exciting development in the push for imaging simplification as a gateway to mechanical thrombectomy (EVT).

Using only non-contrast CT (NCCT)—the most accessible imaging modality worldwide Methinks AI’s software can now detect:

• Large vessel occlusions (LVOs)
• Distal occlusions (including M2 segment of the MCA)
• Intracranial hemorrhages (ICHs)

This capability is especially important for hospitals without access to contrast CT or advanced perfusion imaging. By enabling accurate stroke triage using plain CT, Methinks NCCT Stroke offers a scalable tool to support earlier decision-making, faster transfer, and expanded EVT eligibility, even in rural, low-resource, or under-equipped facilities.

“Methinks NCCT can unlock lifesaving decisions at any hospital,” said CEO Pau Rodríguez.
“No patient should be left behind due to imaging limitations.”

In FDA validation studies, the software demonstrated a significant reduction in false negatives compared to other NCCT tools and is uniquely integrated into Microsoft Teams, supporting real-time stroke team collaboration and seamless PACS integration.

This clearance builds on Methinks’ recent partnership with Medtronic, aimed at extending stroke triage solutions across Central and Eastern Europe, Africa, Turkey, and the Middle East.

As the field of stroke care continues to evolve, this announcement strengthens the case for plain CT + AI as a viable front door to EVT, supporting the mission of making advanced stroke care truly global.

We’re excited to share that our MAP-STROKE study was highlighted by Medscape Medical News for its potential to reshape prehospital stroke routing.

Using simulations of over 115 million stroke scenarios, the study showed that a data-driven algorithm could substantially improve functional outcomes by directing patients especially those with suspected large vessel occlusions (LVO) to the most appropriate stroke centers more quickly.

Highlights:

• Potential for 12,000 more patients/year in the U.S. to reach a good neurological recovery
• Up to 180 minutes saved in time-to-EVT for rural LVO stroke patients
• Based on NIH-funded research; next step: real-world validation

“The algorithm doesn’t replace clinical judgment, algorithm enhances it by helping paramedics make smarter routing decisions in the field,” said Dr. Santiago Ortega-Gutierrez.