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InHeart's AI-Powered Software Module Granted FDA Clearance for Enhanced 3D Heart Model Generation

Wednesday, March 20, 2024

inHEART, a privately-owned medical technology company, has achieved a noteworthy development in the realm of cardiac care. Recently, the company announced that its AI software module has obtained FDA 510(k) clearance. This module facilitates automated segmentation of CT images to create 3D cardiac models, marking a pioneering advancement in streamlining procedures for physicians.

Previously available in the EU, this AI module's clearance now allows inHEART to extend its solutions to hospitals throughout the United States. By leveraging proprietary segmentation algorithms, inHEART's technology generates highly detailed 3D models of the heart from preprocedural CT and/or MR images. These models enable physicians to tailor treatment strategies to each patient's unique cardiac anatomy, aiding in pre-procedural planning and integration with major electroanatomic mapping (EAM) systems.

The incorporation of this new AI module enhances the efficiency of inHEART's solution, providing physicians with a faster and more streamlined approach to cardiac procedures. Early clinical assessments indicate significant potential benefits, including a 60% reduction in ventricular tachycardia (VT) procedure times compared to traditional methods. Moreover, image-guided ablations utilizing inHEART's technology have shown a 38% decrease in VT recurrence rates.

Shorter procedure times not only improve safety but also enhance the overall patient experience. With its innovative AI-driven approach, inHEART aims to deliver superior outcomes and satisfaction for both healthcare providers and patients alike. This achievement underscores the company's commitment to advancing cardiac care through cutting-edge technology and streamlined procedural workflows.

Source: prnewswire.com