FEops has secured approval from the US Food and Drug Administration (FDA) for its anatomical analysis capabilities that are driven by artificial intelligence (AI).

The approval provides physicians with a time-efficient workflow and allows them to make better-informed clinical decisions for structural heart interventions.

FEops’ new anatomical analysis capability includes FEops HEARTguide which involves an AI-based anatomical evaluation of multi-slice computed tomography images for structural heart interventions’ pre-operative planning.

Leveraging FEops HEARTguide, physicians can eliminate the use of manual measurements, thereby consolidating their workflow and securing additional time.

Data from the PREDICT-LAA trial have supported the development of FEops HEARTguide. However, physicians can still opt for performing the analysis on their own.

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.

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“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.”

FEops HEARTguide is an independent procedure planning environment driven by the cloud.

It combines digital twin-based predictive simulation with anatomical measurements fuelled by AI to help medical device companies and clinicians with pre-operative insights into the interaction between transcatheter structural heart devices and the specific patient anatomy.

These insights could enhance clinical results in real-world hospital settings. They can also advance research and development of new device-based tools.

FEops co-founder and CEO Matthieu De Beule said: “With over 7,000 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.”