Unique Innovative in-Procedure Ablation Confirmation Software Receives FDA Clearance

The first and only in-procedure ablation confirmation software that is part of an ablation system, and is intended for the ablation of soft tissue lesions, has received clearance from the US Food and Drug Administration (FDA; Silver Spring, MD USA).

The software was developed by a privately held medical device company and is intended for use with their ablation system. The software uses images from Computed Tomography (CT) scanners and Picture Archiving and Communication Systems (PACS) and helps clinicians identify ablation targets, assess correct placement of ablation probes, and confirm post procedure ablation zones.

The Ablation Confirmation (AC) software, user interface, and NewWave Intelligent Ablation system were developed by NewWave Medical (Madison WI, USA). The AC software imports images from a CT scanner and PACS, and displays them on a dedicated monitor on the NewWave Intelligent Ablation system.

Dan Sullivan, CEO NeuWave Medical, 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. Now, with Ablation Confirmation, only available from NeuWave, there is no need to imagine what the ablation scans look like. The system will overlay pre‐ and post‐ablation scans to show the physician whether or not the ablation is complete, all while never leaving the procedure room. This is game changing for physicians and expected to set a new standard of care for the ablation of soft tissue lesions.”

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