UltraSight Receives FDA Clearance for AI-Powered Cardiac Imaging Tool

PVAD IQ aims to improve access to consistent, rapid echocardiography for patients with microaxial flow pumps

Published on Feb. 25, 2026

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UltraSight, a leader in AI-guided cardiac imaging workflows, has announced that the U.S. Food and Drug Administration (FDA) has cleared its PVAD IQ imaging tool. PVAD IQ is designed to support echocardiography in the management of patients with microaxial flow pumps, helping clinical teams improve access to consistent, rapid bedside imaging to assess pump position and support patient care.

Why it matters

Microaxial flow pumps are increasingly used to manage cardiogenic shock and high-risk cardiac interventions, but timely echocardiographic assessment of pump position and cardiac function remains resource-intensive. PVAD IQ aims to enable a wider range of healthcare providers to acquire diagnostic-quality images, supporting faster, more confident decision-making for these critical patients.

The details

PVAD IQ incorporates insights from a feasibility study that evaluated AI-guided focused cardiac ultrasound (FoCUS) imaging performed by ICU medical professionals. UltraSight's AI-enabled Echosystem allows Advanced Practice Providers, intensivists, and other clinicians to acquire diagnostic-quality images under physician oversight, enabling bedside imaging to support key management decisions for patients with microaxial flow pumps.

  • UltraSight announced FDA clearance of PVAD IQ on February 25, 2026.

The players

UltraSight

A leader in AI-guided cardiac imaging workflows.

Ramya Singh

Chief Commercial Officer at UltraSight.

Mark Bieniarz, MD, FACC, FSCAI

Interventional Cardiologist at the New Mexico Heart Institute, Lovelace Medical Group, and member of the UltraSight Medical Advisory Board.

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What they’re saying

“AI-enabled imaging is transforming how clinicians manage complex cardiac cases. With PVAD IQ, we're helping care teams implement scalable, consistent approaches to patient management—bringing clarity and confidence to some of the most demanding care environments.”

— Ramya Singh, Chief Commercial Officer at UltraSight (EINPresswire.com)

“For patients supported by microaxial flow pumps, timely and reliable insight into pump function and positioning is essential. AI-guided FoCUS offers a meaningful opportunity to strengthen bedside pump position assessment. A standardized approach can help teams make faster, more confident decisions and improve coordination across interventional cardiology, heart failure, and critical care.”

— Mark Bieniarz, MD, FACC, FSCAI, Interventional Cardiologist at the New Mexico Heart Institute, Lovelace Medical Group, and member of the UltraSight Medical Advisory Board (EINPresswire.com)

What’s next

Plans for formal market introduction of PVAD IQ remain under development to ensure alignment with evolving clinical workflows.

The takeaway

UltraSight's PVAD IQ represents an important advancement in AI-enabled cardiac imaging, empowering a wider range of healthcare providers to support critical patients with microaxial flow pumps through consistent, rapid bedside assessment of pump position and cardiac function.