DASI Simulations

Company overview

DASI Simulations develops medical-device software for structural heart care, with a focus on planning transcatheter aortic valve replacement (TAVR). Its platform combines patient CT imaging, computational modeling and AI-assisted image processing to support assessment of cardiovascular anatomy and valve deployment.

PrecisionTAVI models the interaction of selected transcatheter heart valves with patient-specific anatomy. DASI Dimensions generates cardiac images and anatomical measurements using AI-assisted processing with engineer quality checks. These are separate FDA-cleared products with distinct functions and labeling; clinicians retain responsibility for interpretation and treatment decisions.

Founded in December 2019 by Teri Sirset and Lakshmi Dasi, the company is based in Dublin, Ohio. Sirset serves as President and CEO, Dasi as CTO, and Sean McKibben as COO. DASI offers its planning workflow to clinical teams through a browser-accessible portal and reports a pay-per-analysis commercial model.

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Products & regulatory status How does MedTechIndex get this information?

Summary

PrecisionTAVI v1.1 received FDA 510(k) clearance K223809 on May 30, 2023 for patient-specific TAVR planning simulations. Its cleared function predicts valve-frame deformation for selected valve types and sizes; the cited submission describes Edwards SAPIEN 3/Ultra balloon-expandable valves. Broader modeling or future guidance features should not be assumed to share this authorization. ^[11][8]

DASI Dimensions v1.0 received FDA 510(k) clearance K231324 on January 8, 2024. It provides predefined images and cardiovascular measurements for clinicians evaluating patients with aortic stenosis. AI-assisted processing is quality-checked by DASI engineers before results are released; the software supports clinical interpretation and does not make treatment decisions. ^[12][9]

No matching recall events were identified in the FDA recall and enforcement datasets searched under DASI Simulations, PrecisionTAVI and DASI Dimensions. ^[13]

Regulatory snapshot How to read this snapshot

U.S. FDA

2

510(k) clearances

—

De Novo grants

0

PMA approvals

0

Recall events

Latest recorded source review: 2026-10-22.

Commercial portfolio snapshot

Documented commercial product families.

Cardiovascular implant simulation software

PrecisionTAVI ↗

CT-derived patient-specific simulation of selected transcatheter heart valve deployment, delivered through a planning report and interactive visualizations. ^[7][8][1]

FDA-cleared

Offered to clinical teams through DASI’s planning workflow and portal.

Cardiac image-processing software

DASI Dimensions ↗

AI-assisted processing of cardiac CT images to produce anatomical measurements and images for pre-procedural structural heart planning. ^[6][9]

FDA-cleared

Commercialized in the U.S. as part of DASI’s structural heart planning workflow; current configurations should be confirmed with the company.

Commercial development

DASI’s website advertises a forthcoming treatment app for visualizing structural heart treatment options. It is presented here as a development announcement; a separate launch date and FDA authorization were not established. ^[1]