Belgium-based digital health company FEops has obtained the US Food and Drug Administration (FDA) De Novo authorisation for its HEARTguide tool.

HEARTguide is a procedure planning platform that facilitates pre-operative planning of left atrial appendage occlusion (LAAo) using the Boston Scientific WATCHMAN devices.

It enables physicians to virtually model clinical scenarios with various implant positions and sizes of the WATCHMAN device, and help determine the optimal size and position for each patient, said FEops.

FEops co-founder and CTO Peter Mortier said: “FDA authorization of FEops HEARTguide is a significant milestone as this is the first Interventional Cardiovascular Implant Simulation Software Device cleared on the US market.

“Research on this technology began more than 10 years ago. We have continued to develop it with the goal of helping healthcare professionals identify the most appropriate treatment strategy for each patient precisely, safely and efficiently.

“This De Novo clearance is only a first step, and we are already preparing for FDA 510(k) submissions for FEops HEARTguide LAAo workflow with Abbott’s Amplatzer Amulet device and Boston Scientific’s WATCHMAN FLX device.”

HEARTguide is designed to provide physicians with insights to evaluate device sizing and positioning pre-operatively in structural heart interventions.

It leverages digital twin technology based on patient-specific virtual replicas of the heart.

The cloud-based procedure planning platform offers insights into the interaction between transcatheter structural heart devices and specific patient anatomy, pre-operatively.

In addition, the insights include quality controlled, validated and AI-enabled anatomical analyses to improve clinical outcomes in real-world hospital settings.

Prior to the FDA approval with WATCHMAN devices, FEops HEARTguide has been commercially available in the EU, UK, Canada and Australia, for TAVI and LAAo workflows.

Last year, the device was introduced in the US for the prediction of paravalvular leak (PVL) and conduction abnormalities (CA) for the transcatheter aortic valve implantation (TAVI).

Jacqueline Saw from Vancouver General Hospital, Canada said: “The pre-operative insight provided by FEops HEARTguide is powerful and can help me to optimize decision making for selecting optimal device size and position.

“FEops HEARTguide is an intuitive platform I can use to discuss cases with the entire heart team to streamline my pre-op planning workflow.”