NeuWave Medical gets FDA clearance for software upgrade to its ablation system

Ablation Confirmation User Interface: Confirmation of Ablation Plus Margin 3D Visualization of target lesion post-ablation (turns green)--if any of the target lesion remains post-ablation it would appear red--Courtesy of NeuWave Medical

NeuWave Medical received FDA clearance to add the Ablation Confirmation software to its ablation device for the elimination of benign and malignant soft-tissue lesions of the lung, kidney and liver. The privately held company based in Madison, WI, says it's the first in-procedure ablation confirmation software available on an ablation system.

Ablation Confirmation processes CT images to help doctors find ablation targets, perform the procedure and confirm that the lesion has been ablated via the delivery of focused heat from the system's antennas, also called probes. Up to three of the percutaneous probes are placed directly into the lesion and produce heat by emitting microwave energy.

Features of the software include semi-automated lesion identification capabilities, 2-D and 3-D visualization capabilities--including an overlaid ablation zone--and remote reviewing capabilities that enable collaboration from an external computer. The information is displayed on a separate monitor located on the company's ablation system.

"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," said NeuWave CEO, Dan Sullivan, in a statement. "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."

Sullivan was a co-founder of lung cancer diagnostic company SuperDimension, which was sold to Covidien (now Medtronic) in 2012. He also co-founded Vascular Science and Atritech, which were sold to St. Jude Medical ($STJ) and Boston Scientific ($BSX) respectively.

NeuWave says its Intelligent Ablation System is being used in more than half of the leading cancer centers in the U.S. It delivers microwave ablation, typically as an outpatient procedure under moderate sedation.

In May, the company announced that it received $25 million in a Series C financing round led by Versant Ventures.

NeuWave also sells probes and tools that are compatible with the ablation system, but the announcement is a reminder that advances in software are becoming a key differentiator in device world.

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