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LUMA raises $22m to secure FDA clearance for 4D cardiac imaging

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LUMA Vision has raised $22m in Series A3 financing to fund the FDA clearance and commercialisation of Verafeye in the country.

The financiers included EQT Lifesciences, ABV Uni Fund, imec.xpand, Atlantic Bridge Growth Fund and Bayern Kapital. It builds on previous funding from the Irish Government’s Disruptive Technologies Innovation Fund and the European Union’s EIC Accelerator grants of $6m and $3m, respectively.

Verafeye is a four-dimensional (4D) cardiac imaging and navigation platform that uses a proprietary catheter sensor combined with advanced digital imaging and deep learning to provide real-time guidance during cardiac surgery. Thereby, eliminating the need for external systems such as X-ray or CT scan.

The use of artificial intelligence (AI) such as deep learning has been increasing in the medical device sector. GobalData forecasts the AI market to reach sales of $93bn in 2023, a 12% increase from 2022. Many companies have invested in using AI in cardiac imaging.

In June, GE HealthCare launched a cardiac magnetic resonance imaging (MRI) testing device that uses deep learning. The technology can scan up to 12 times faster than current approaches meaning lengthy exam times often associated with cardiac MRIs, the gold standard for evaluating cardiac function, may be reduced.

In June, North Carolina-based Core Sound Imaging announced plans to preview its AI cardiac workflow solutions. The technology allows a cardiologist to choose from a menu of AI vendors and selectively utilise these AI tools on one or all exams. The technology is being piloted at the Mount Sinai Health System for echocardiogram (ECG) viewing and reporting.

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By GlobalData

Other advancements in cardiac imaging include Hyperfine’s portable MRI system, which is being trialled in an observational system in children with neurological injuries. The FDA-cleared Swoop system can provide brain MRI capabilities at the point of care. In September, CorVista Health’s non-invasive medical device system with a coronary artery disease add-on option for detecting the presence of cardiac disease was cleared by the FDA.

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