Methinks and the EIC Accelerator: Stroke AI Cleared in the US
Methinks AI, a Barcelona company led by CEO Pau Rodríguez, makes software that reads brain CT scans to find strokes. Its EIC project said evaluating all treatment options needs advanced imaging that about half of hospitals cannot offer around the clock, and that Methinks would do it "with standard medical imaging, which is available 24/7 in any hospital", saving up to 60 minutes to treatment, according to CORDIS.
The European Innovation Council granted €2,495,415 towards a €3.56 million project from February 2023 to January 2025. The final report says Methinks optimised its models, updated its CE mark, applied to the FDA, validated the software in European and US studies and built an app inside Microsoft Teams for stroke teams. It says a distribution agreement with Medtronic and "our first direct sales" followed just after the project ended. The FDA cleared Methinks NCCT Stroke in June 2025 and Methinks CTA Stroke in August 2025, according to the FDA's 510(k) database. In November 2023 the EIC Fund had joined €2.5 million of convertible loans with other investors.
Company file
- Legal entity
- Methinks Software S.L., VAT ESB66793993, Barcelona
- CEO
- Pau Rodríguez
- Products
- Methinks NCCT Stroke, Methinks CTA Stroke, Teams app
- Approvals
- CE mark (January 2023); FDA 510(k) K250685 and K251590 (2025)
- Partner
- Medtronic (distribution)
- EIC project
- Deepstroke-Acc, 1 Feb 2023 to 31 Jan 2025, closed
- EIC funding
- Blended finance: grant plus EIC Fund convertible loan
Where Methinks Stands Now
After its second clearance, Methinks said the two products together offer a stroke triage platform "compatible with both NCCT and CTA imaging", and CEO Pau Rodríguez said the clearances showed "our ability to deliver advanced, accessible stroke care solutions across US hospitals", according to its October 2025 release. Its website quotes clinicians at Advocate Aurora Health and Cooper University Healthcare in the US and Vall d'Hebron in Barcelona. When the EIC Fund invested in 2023, the company expected FDA clearance "mid next year", in 2024; it came about a year later.
The record
Stroke AI from CE mark to two FDA clearances
Methinks used its EIC project to optimise its stroke software and apply to the FDA. Clearances came in 2025, about a year after the company had said it expected them, followed by a Medtronic distribution deal.
- Jun 2022EIC Accelerator cut-offDeepstroke-Accblended finance
- Jan 2023CE markMethinks Stroke Suite
- Feb 2023EIC project starts€3.56M project€2.50M grant
- Nov 2023EIC Fund investsConvertible loans with other investors€2.5M
- Jan 2025EIC project endsFDA applications filed; Teams app launched
- Early 2025Medtronic dealDistribution agreement; first direct sales
- Jun 2025First FDA clearanceNCCT Stroke, K250685
- Aug 2025Second FDA clearanceCTA Stroke, K251590
CORDIS, FDA, Catalonia.health and Methinks.
"All of this has allowed us to validate our product-market fit, which was further confirmed just after the project's conclusion with the signing of a distribution agreement with Medtronic and our first direct sales."
Methinks, final report to the EICThe Technology: Reading Plain CT for Clots
Non-contrast CT is the quickest scan for suspected stroke, but it usually does not show blocked vessels; that normally needs CT angiography, which requires injecting contrast and trained staff. Methinks trains AI to detect large vessel occlusions and haemorrhages on the plain scan. Its website gives a sensitivity of 76.4% and specificity of 91.1% for occlusions on plain CT, and its CTA product reached 98.2% sensitivity. The report says Methinks is the only company with a CE mark for occlusion detection on plain CT.
The performance
Accuracy Methinks reports for its AI
Sensitivity and specificity shown on the company's website for large vessel occlusion (LVO) and intracerebral haemorrhage (ICH) on non-contrast CT, and in its release for CTA.
Methinks website and October 2025 release.
What the EIC Project Promised, and What CORDIS Shows
The EIC project
The EU paid 70% of a €3.6M project
Deepstroke-Acc ran from February 2023 to January 2025. CORDIS lists it as closed.
CORDIS project 190136266. Values in € millions.
The project set out to optimise the product and AI models for market entry and scale. It delivered an updated CE mark, FDA submissions that led to two clearances, validation studies in Europe and the US and a Teams-based app. The commercial result, a distribution deal and first sales, arrived as the project closed. CORDIS lists the project as closed.
- Optimised AI and productDeliveredCE mark updated.
- FDA clearanceDeliveredTwo 510(k)s, 2025.
- Clinical validationDeliveredEU and US studies.
- Commercial scaleUnverifiedFirst sales; revenue not public.
The Money
The 2023 convertible loans, led by the EIC Fund, were raised "to prepare for its upcoming investment round", Catalonia.health reported. A larger round has not been announced. Methinks has not published revenue or the number of hospitals using its software.
The problem
Hospitals able to run advanced stroke imaging around the clock
Share of hospitals worldwide able to perform CT angiography (CTA) and CT perfusion (CTP) 24/7, as cited in the EIC report. Plain CT is available almost everywhere.
CORDIS project 190136266, final report.
What Cannot Be Checked
Questions for the EIC
How much of the €2.5 million came from the EIC Fund, how many hospitals pay for Methinks, what the Medtronic deal covers and whether the planned investment round closed are not public.
Why Europe Should Care
The report says only about 30% of European stroke patients get specialised stroke unit care, mostly in cities. Software that makes plain CT more useful could narrow that gap. The EIC backed a Spanish company that went on to win two FDA clearances.
What the project promised
An optimised stroke AI ready for market entry and scale, working on standard imaging in any hospital.
What the record shows
Two FDA clearances, an updated CE mark, a Medtronic distribution deal and first sales by the company's account, with revenue undisclosed.
The Verdict
Cleared in the US
Methinks reports doing what the EIC paid for: it won two FDA clearances and says it signed a distribution agreement with Medtronic. How many hospitals use it, and how much it earns, has not been disclosed.
Methinks and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
Industry
HealthMedical devices
- Focus
- Medical imaging
- Technologies
- Artificial intelligence
- Keywords
- Stroke
- CT scans
- Large vessel occlusion
- Stroke triage