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NeuWave Medical’s new Ablation Confirmation software receives FDA approval

Medical device firm NeuWave Medical has received approval from the US Food and Drug Administration (FDA) for its new Ablation Confirmation (AC) software that is incorporated into the NeuWave Intelligent Ablation System.


Ablation Confirmation is a computed tomography (CT) image processing software package that is designed to help physicians to identify ablation targets, assess proper ablation probe placement and confirm ablation zones post-procedure.

NeuWave Medical CEO Dan Sullivan said: "This is a significant step forward, as today physicians performing an ablation have to view patient CT scans with the naked eye on side by side monitors outside the procedure room.

"Comparing pre- and post-ablation CT scans is cumbersome and requires the user to ‘imagine’ what the scans would look like if they were overlaid to determine whether or not the lesion has been ablated."

The new software is said to import images from CT scanners and facility PACS systems for display and processing during ablation procedures. It is accessible to physicians through a monitor with its own user interface on the NeuWave Intelligent Ablation System.

It allows in semi-automated lesion identification, as well as 2D and 3D visualization. AC draws images directly into the software for in-procedure review, enabling physician to review probe placement and ablation confirmation and never break scrub.

With the FDA approval, the new system has become the only one to offer computer-controlled synchronous energy delivery for multi-probe ablations, Ablation Confirmation for in-procedure review of probe placement and confirmation of the ablation zone, and big data access for use in case reporting, referral follow up, data publication and to establish potential treatment protocols.

Image: New Ablation Confirmation software is incorporated into the NeuWave Intelligent Ablation System. Photo: courtesy of NeuWave Medical Inc.