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LARALAB receives FDA 510(k) clearance! 

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The optimal treatment path,
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Powered by the most precise AI
in structural heart care

heart.ai is the first fully automated cloud-based solution for cardiac interventions

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Data-driven insights

heart.ai enables partners to build their own research registry

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Validated in 20+ clinical publications,
involving over 1000 patient datasets

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FDA 510(k) cleared
CE marked (under MDR)

Powered by the most precise
AI in structural heart

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With REC Rapid Eligibility Check

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How it works

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Latest Updates

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June 2025

Novel use cases of heart.ai presented at NYValves, covering TMVR eligibility assessment, remodelling after TMVr and the latest TTVR-AHI registry updates.

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May 2025

Dr. Omar Khalique, MD, presents heart.ai FDA performance study results at SCAI 2025

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April 2025

Press Release: LARALAB’s Platform Receives FDA 510(k) Clearance

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April 2025

LMU Hospital and LARALAB partner on Generative AI for Cardiac Treatments

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