Company Spotlight: HistoSonics Planning Tool - AI Mapping for Histotripsy

We unpack the FDA 510(k) summary for the HistoSonics Planning Tool, cleared in May 2026. This episode explores how the standalone software uses machine learning to segment organs and map acoustic pathways for histotripsy procedures. We dive into the training data, the validation subsets, and what this clearance means for clinical workflows.

Key points

• The FDA cleared the HistoSonics Planning Tool as a Class II medical image management and processing system based on substantial equivalence to a 2019 microwave ablation visualization device.
• The software uses static machine learning models to automatically segment the liver, kidneys, lungs, and ribs in CT and MRI scans to help plan acoustic pathways.
• Performance testing showed the liver segmentation model achieved a mean Dice score of 93%, exceeding the target of 70% or higher in 70% of cases.
• The validation relied entirely on retrospective datasets, including subsets of 10 patients from larger public databases, with some imaging data dating back to the period from 1991 to 1995.
• Because it is a planning tool, the device was cleared through software testing and did not require new animal or human clinical studies.

Source: FDA 510(k) summary K252947: HistoSonics® Planning Tool (HistoSonics) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: HistoSonics (histosonics.com) · Product: HistoSonics® Planning Tool · FDA 510(k) K252947

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-histosonics-planning-tool-ai-mapping-for-histotripsy-752a1c