FDA Issues Expanded Clearance for UltraSight’s Cardiac Ultrasound Echo Stewardship Program

The Food and Drug Administration (FDA) has expanded 510(k) clearance for use of UltraSight’s Echo Stewardship Program across multiple ultrasound platforms, facilitating the performance of focused cardiac ultrasound exams by trained clinicians including advanced practice providers (APPs).

Emphasizing real-time artificial intelligence (AI)-assisted acquisition of ultrasound images and optimal views, UltraSight said the technology in concert with the Echo Stewardship Program enables smooth onboarding for non-sonographer providers to obtain quality cardiac ultrasound images via handheld, laptop and cart-based platforms.

While noting that physician oversight for final interpretation and reporting is essential for the Echo Stewardship Program, UltraSight maintained that the expanded clearance for the Echo Stewardship Program helps address challenges with imaging backlogs and access to timely cardiac evaluations.

“Health systems want to increase their capacity for timely cardiac assessment without overhauling their hardware or relying on a single vendor,” said Davidi Vortman, the CEO of UltraSight. “The FDA clearance supports a scalable workflow solution, enabling more clinicians to acquire high-quality FoCUS exams and helping hospitals reduce backlogs, manage variability, and expand access to cardiac care.”