Medical Device News Magazine

inHEART Receives CE Certification Under New MDR for Novel AI-Based Digital Twin of the Heart

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

inHEART, a privately-held medical device company delivering the world’s most advanced digital twin of the patient’s heart, announced today that it has received CE certification under the new European Medical Device Regulation (MDR 2017/745) for its inHEART MODELS software suite that enables 3D visualization and analysis of anatomical structures for image-guided cardiac ablations. With this certification, inHEART will deliver fully automated segmentation of medical images with a new software module based on machine-learning technology to European customers. In addition, this certification will facilitate a swift pace of ongoing software enhancements.

Additional features of the inHEART solution already available in the US and now available in Europe with the new CE Mark MDR certification include new information (scar transmurality and left atrium wall thickness), new visualization and measurement tools, and an enhanced user experience.

“inHEART remains committed to delivering solutions that meet or exceed the highest quality and regulatory standards,” said Todor Jeliaskov, President and CEO of inHEART. “With this CE Mark MDR certification, we demonstrate our commitment to provide physicians with 3D cardiac models they can trust to help them determine the optimal treatment plan for each unique patient. I am proud of the inHEART team and their commitment to this level of excellence.”

The inHEART solution aims to address many of the challenges of conventional cardiac ablations with its proprietary segmentation algorithm that analyzes preprocedural CT and/or MR images to create highly detailed, interactive 3D models of the heart. This information allows physicians to optimize treatment strategies for cardiac ablation procedures based on each patient’s unique cardiac anatomy and supports pre-procedural planning and seamless integration into all major electroanatomic mapping (EAM) systems.

Early clinical evaluations have shown a potential to reduce VT procedure times by 60% as compared to the conventional approach (from 5 hours to less than 2 hours). Shorter procedures are typically associated with superior safety and patient experience. In addition, these evaluations have demonstrated the potential for image-guided ablations to reduce failure rate by 38%, as compared to the conventional approach.1

1 Data on file


Medical Device News Magazine
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.