Boston, MA | February 25, 2026 — UltraSight™, a leader in AI-guided cardiac imaging workflows, today announced U.S. Food and Drug Administration (FDA) clearance of PVAD IQ, an imaging tool used with the company’s Echo Stewardship Platform designed to support echocardiography in the management of patients with a microaxial flow pump. This tool is intended to help clinical teams improve access to consistent, rapid echocardiography imaging and pump position assessment for patients on the device.

Microaxial flow pumps are increasingly used in the management of cardiogenic shock and high-risk cardiac interventions, with tens of thousands of patients supported annually in U.S. hospitals. Yet timely echocardiographic assessment of pump position and cardiac function remains resource-intensive and often limited by sonographer availability—particularly in critical care and off-hours settings. PVAD IQ is intended to help clinical teams improve access to consistent, rapid bedside imaging to support pump position assessment and patient management.

PVAD IQ incorporates insights from a first-in-human feasibility study conducted at Shamir Medical Center in Israel, which evaluated AI-guided focused cardiac ultrasound (FoCUS) imaging performed by ICU medical professionals. UltraSight’s AI-enabled Echosystem enables a range of healthcare providers including Advanced Practice Providers (APPs), intensivists, and clinicians who have not previously performed echocardiography—to acquire diagnostic-quality images under qualified physician oversight. With PVAD IQ, teams can use bedside imaging to support key management decisions.

“AI-enabled imaging is transforming how clinicians manage complex cardiac cases,” said Ramya Singh, Chief Commercial Officer at UltraSight. “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.” 

“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,” said Mark Bieniarz, MD, FACC, FSCAI, Interventional Cardiologist at the New Mexico Heart Institute, Lovelace Medical Group, and member of the UltraSight Medical Advisory Board. “A standardized approach can help teams make faster, more confident decisions and improve coordination across interventional cardiology, heart failure, and critical care.”

Plans for formal market introduction remain under development to ensure alignment with evolving clinical workflows. For more information, please contact info@ultrasight.com.

1 Ko DT, Ayayo S, Banerjee A, et al. Trends in Utilization of Microaxial Flow Pump and Intra-Aortic

Balloon Pump Across 3 Countries. JAMA Intern Med. 2025;185(10):1291-1293.

doi:10.1001/jamainternmed.2025.3881