Irish medical technology company Luma Vision has secured US regulatory clearance for its cardiac imaging device for use in the treatment of patients suffering from arrhythmias like atrial fibrillation.
Formerly known as OneProjects, the company has developed a catheter-mounted sensor system that can take 360-degree, high-resolution images of the human heart. The device represents a significant advancement on currently available technologies that only produce two-dimensional images.
The United States’s Food and Drug Administration (FDA), which regulates all medicines and medical devices in the world’s largest medical market, has now cleared Luma Vision’s Verafeye Visualisation Platform for use in the US.
Dubliner Fionn Lahart, who cofounded the company with his business partner Christoph Hennersperger, said FDA clearance represents a significant milestone for the Dublin and Munich-headquartered company.
“Our first market approval is in the US, which is our biggest market,” he said. “There’s a lot of activity in the cardiology market and, thankfully, our technology can fit in with the procedures of today and the procedures of the future. So it’s a big milestone for us as we look towards US commercialisation.”
Mr Lahart said there are “a lot of opportunities” ahead for the business “across a range of different cardiology procedures”.
He said the company is already developing its next product, which it will submit to the FDA for approval later in the year.
“We have another new product coming next year as well,” he said. “But this is the first approval, and it’s kind of a foundational approval, that we can then build different applications on top of for different heart surgeries.”
Luma Vision’s technology is designed to provide better, more detailed images of the heart for doctors treating cardiac irregularities like atrial fibrillation.
Mr Hennesperger told The Irish Times in 2022 that the problem with current treatment is that every second patient has to come back “two, three or four times” for repeat procedures because doctors “can’t directly see what’s going on” using existing technologies.
Mr Lahart and Mr Hennersperger, who won the emerging category in the 2022 EY Entrepreneur of the Year awards, met in 2015 while participating in the University of Galway’s medical technology accelerator programme, BioInnovate, and incorporated the business two years later.
So far, Luma Vision, which employs almost 70 people at its offices in Clonskeagh in south Dublin, has raised around $50 million from sources including EQT Life Sciences (formerly LSP), venture capital firm Atlantic Bridge and Imec.xpand, a Belgian early-stage and growth fund.
