Belgium-based digital heart company FEops has received the US Food and Drug Administration (FDA) approval for new anatomical analysis capabilities, driven by artificial intelligence (AI).

The new anatomical analysis capability includes FEops HEARTguide, which enables AI-based anatomical evaluation of multi-slice computed tomography (MSCT) images.

Backed by the strong clinical evidence from PREDICT-LAA clinical trial, the solution enables better-informed clinical decision-making for structural heart interventions.

In addition to anatomical analysis, it offers predictive simulations to reveal how transcatheter structural heart devices interact with a patient’s anatomy prior to implant.

FEops HEARTguide helps physicians in selecting the optimal device size and position, to improve procedure efficiency and outcome, said the digital heart company.

FEops co-founder and CTO Peter Mortier said: “We are staying ahead of the market with the introduction of this unique combination of predictive simulation and AI-enabled anatomical analysis.

“This extension of FEops HEARTguide enables a time efficient workflow for heart teams by providing them a fast, semi-automated and accurate anatomical analysis for efficient and standardised planning.”

The FEops HEARTguide is a unique, stand-alone cloud-based procedure planning environment, that combines digital twin-based predictive simulation with AI-based anatomical measurements.

It provides clinicians and medical device manufacturers with insights into the interaction between transcatheter structural heart devices and specific patient anatomy, preoperatively.

The insights provided by FEops HEARTguide can improve clinical outcomes in real-world hospital settings, and advance research and development of new device-based solutions.

FEops HEARTguide is being offered in the US for use in left atrial appendage occlusion (LAAO) with Amplatzer Amulet, Watchman, and Watchman FLX devices.

The solution is also available in the EU, the UK, Canada, and Australia, for use in transcatheter aortic valve replacement (TAVI) and LAAO.

FEops co-founder and CEO Matthieu De Beule said: “FEops is on track to install the new standard in personalized treatment planning for structural heart interventions and brings us on the verge of global commercialisation.

“With over 7000 patients treated worldwide in 327 hospitals spread over 28 countries, FEops is ready and uniquely positioned to extend its cloud-based platform outside of the structural heart space by leveraging its AI know-how, regulatory expertise, physician network and clinical footprint.

“This is putting us in pole position to extend our game-changing predictive digital twin offering to other applications with our upcoming Series C round.”