From EIC Accelerator Grant to FDA: LUMA Vision's 4D Heart Catheter

Doctors who treat atrial fibrillation by scarring heart tissue with a catheter cannot see the scars they make. OneProjects Design Innovation, a 2017 spin-out of Trinity College Dublin and NUI Galway, told the European Innovation Council it would fix that with VERAFEYE, a catheter that images the beating heart in four dimensions and checks each ablation as it happens. The EIC selected the project in its March 2020 Accelerator pilot round, grant only, and paid €2.5 million towards a €4.35 million project whose title promised to "enable >90% success rate in Atrial Fibrillation treatment".

Six years on, the company is called LUMA Vision and VERAFEYE is real. The US Food and Drug Administration has cleared it three times, in March 2025, June 2026 and July 2026, and the company plans a US commercial launch in early 2027, according to MassDevice. The device was not approved within the EU project, and the success rate in its title has not been demonstrated in any published trial.

Where LUMA Vision Stands Now

LUMA Vision is active, and no commercial sale of VERAFEYE has been announced. On 9 September 2026 it announced FDA clearance for an expanded VERAFEYE system that builds 3D models of the atria, tracks catheters electromagnetically and visualises ablations in real time, and said commercial launch would follow in early 2027, according to the company's release as published by EP Lab Digest and reported by MassDevice. The FDA database records that clearance, K260885, on 15 June 2026, and a further clearance for a new imaging catheter, K261849, on 24 July 2026.

The launch date has slipped before. In March 2026 the company said the latest version would form "the basis of the 2026 commercial launch", according to Cardiac Rhythm News. Bayern Kapital, one of its investors, wrote in 2025 that commercialisation at five identified US sites would begin in early 2026 and that a new financing round was under discussion, according to Bayern Kapital. No new round has been announced since December 2023.

The Technology: Ultrasound From Inside the Heart, in 4D

Catheter ablation scars small areas of heart tissue to block the stray electrical signals that cause atrial fibrillation. The CORDIS project report says doctors cannot see the lesions they create and rely on surrogate markers, that first-time success rates are only 53 to 61%, and that patients often return for repeat procedures. The established guidance tools, electroanatomical mapping systems, give only 3D information "with limited detail and precision", the report says.

VERAFEYE is an intracardiac ultrasound catheter. Conventional imaging catheters show a 2D slice; LUMA's records a 360-degree volume that updates in real time, reaching up to 120 mm from the catheter tip, according to Cardiovascular Business and Cardiac Rhythm News. The company says its software reconstructs both atria at "CT quality" in under 60 seconds and magnetically tracks catheters from other manufacturers, so doctors can keep their preferred ablation system, according to its first-in-human announcement. In 2026 European studies, patients were treated with several pulsed field ablation systems under VERAFEYE guidance, Cardiac Rhythm News reported.

The pitch has shifted along the way. The EIC proposal centred on verifying each ablation lesion to raise success rates above 90%. The cleared product is sold as an imaging, navigation and guidance platform that replaces several tools in the lab, with expansion into left atrial appendage closure and other structural heart procedures planned. The FDA classes it under intravascular ultrasound catheters.

What the EIC Project Promised, and What CORDIS Shows

The Commission's list of selected companies for the March and May 2020 cut-offs names OneProjects Design Innovation Limited of Dublin once, with VERAFEYE as a grant-only project; no other partner company is listed. CORDIS shows that the Munich subsidiary, registered in August 2020, later joined as a linked third party with €1.0 million of the grant. The grant agreement was signed on 8 September 2020, and the project ran from 1 October 2020 to 30 June 2023, according to the CORDIS fact sheet.

The project report describes a "24-month EIC project" meant to take VERAFEYE "through market approval", with five work packages from product development to manufacturing. The project ran 33 months. Its report for the second and last period, October 2021 to June 2023, lists catheter design iterations, bench and ex-vivo tests, the start of a quality management system, a regulatory strategy for the US and EU, pre-clinical studies and clinical site selection. It reports no patient use and no approval. The CORDIS results page lists no deliverables or publications.

1. Working 4D imaging catheter and consoleDeliveredBuilt during the project; first patients treated in January 2025, per ClinicalTrials.gov.
2. Market approval within the projectLateFirst FDA clearance on 24 March 2025, almost 21 months after the project closed.
3. European market approval (CE mark)Not achievedNo CE mark announced by the company or reported elsewhere.
4. Real-time ablation and tissue analysisPartlyThe 2026 release says the cleared system visualises and documents ablations in real time; lesion depth verification not shown.
5. >90% success rate in AF ablationNot shownNo trial reporting freedom from atrial fibrillation has been published.
6. Clinical validationPartly18-patient feasibility study with physician ratings as its endpoint, completed May 2025.

The clinical record is thin for a device sold on outcomes. LUMINIZE, the first-in-human study at the Mater Private Network in Dublin, enrolled 18 patients between January and May 2025. Its primary endpoint was physician feedback by questionnaire; the posted results on ClinicalTrials.gov rate navigation, visualisation and catheter handling as acceptable or better in 100% of answers, with no serious adverse events among 17 patients at risk. A follow-up registry, ENLIgHT, registered in 2024 for 50 patients, is still not recruiting and now has an estimated start of May 2027. Its primary endpoint is acute procedural success, not freedom from atrial fibrillation. In March 2026 the company announced first enrolments in two European studies in Prague and Split, Cardiac Rhythm News reported; no results are public.

What LUMA Vision Has Achieved Since the Award

The money arrived around the grant. In June 2020 OneProjects raised an €11 million Series A led by LSP with Atlantic Bridge University Fund and Enterprise Ireland, according to European Biotechnology and Knowledge Transfer Ireland. In October 2021 it announced $17 million: an $8 million Series A2 led by imec.xpand with the EIC Fund, LSP and Atlantic Bridge, plus grants of $6 million from Ireland's Disruptive Technologies Innovation Fund and $3 million from the EIC Accelerator, according to Trinity College Dublin and Knowledge Transfer Ireland. The $3 million figure is the dollar value of the €2.5 million EIC grant that CORDIS records; the grant itself had been signed a year earlier. LSP became EQT Life Sciences when EQT completed its acquisition on 28 February 2022.

In December 2023 LUMA Vision raised a $22 million Series A3 led by EQT Life Sciences, ABV Uni Fund and imec.xpand, adding Atlantic Bridge Growth Fund, Bayern Kapital and an undisclosed multinational strategic investor, to pay for FDA clearance and US launch preparation, according to Trinity College Dublin and Munich Startup. Recognition followed: the founders won the Emerging Entrepreneurs award at the EY Entrepreneur of the Year event in 2022 and the company was named Emerging Medtech Company of the Year at the Irish Medtech Awards in December 2024, according to the company's news page. The Munich subsidiary received €299,000 of Bavarian state aid in October 2023, according to North Data.

The Money and the Register

The Companies Registration Office's open company record lists LUMA Vision Limited, number 606427, as "Normal", registered on 20 June 2017 and under its current name since 21 April 2023, at Beech Hill Office Campus in Clonskeagh, Dublin. Its latest annual return is made up to 30 September 2024 and its latest accounts to 31 December 2023; the record gives 30 September 2025 as the next annual return date, and whether a later return is being processed could not be checked. OpenCorporates lists seven share allotment filings on 10 February 2025 and an auditor resignation on 4 June 2025. The amounts allotted are not in the free data.

Neither the Irish accounts nor those of the Munich GmbH, which filed reports for 2022, 2023 and 2024 according to North Data, are available free of charge, so revenue, losses, cash and headcount could not be verified. The company website names 52 staff across Dublin and Munich, and the FDA clearances list the Dublin company as applicant.

Why Europe Should Care

Cardiovascular disease kills 1.7 million people a year in the EU, and in December 2025 the Commission adopted the Safe Hearts Plan, its first strategy for cardiovascular health, including an incubator for AI and digital technologies in cardiovascular care. The CORDIS report notes that Europe is projected to see the greatest increase in atrial fibrillation worldwide by 2050. LUMA Vision is the kind of company the plan has in mind: an Irish-German developer, with Irish and Bavarian public money in its cap table, and Ireland's and Bavaria's health ministers visited its Munich site together in 2026, Cardiac Rhythm News reported.

Its regulatory path points the other way. All three clearances so far are American, the first commercial sites named by its investor are in the US, and its launch plan is a US launch. European patients have so far met VERAFEYE only in studies.

The Verdict

LUMA Vision has not been asked for comment for this article. It is based entirely on public records, company statements and EU project data, linked throughout.