inHEART’s AI-Based Software Module Obtains the US FDA’s Clearance for Creating 3D Cardiac Models
Shots:
- The US FDA has granted 510(k) clearance to inHEART’s AI-based software module which enables the formation of 3D cardiac models
- The module forms 3D cardiac models using AI segmentation algorithm from CT/MR scans enabling treatment optimization based on the patient’s cardiac anatomy to support pre-procedural planning & combining with EAM systems
- The early clinical assessments of the device have shown a reduction in the VT procedure time by 60% vs traditional method (from 5hrs. to <2hrs.) and also depicted that image-guided ablations decreased VT recurrence rates by 38% vs traditional ablation methods
Ref: inHEART | Image: inHEART
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
