FDA clears expanded use of AI that helps novice users perform echo exams
The U.S. Food and Drug Administration (FDA) has cleared an expansion of UltraSight's Echo Stewardship Platform that means it will now support compatibility with a wider variety of ultrasound systems. This enables the deployment of artificial intelligence (AI) guidance for focused cardiac ultrasound (FoCUS) across an entire healthcare system without the need to buy new ultrasound systems. Instead, providers can use compatible equipment they already own, including handheld, laptop and cart-based systems.
The UltraSight technology offers real-time, AI-assisted image acquisition that helps guide clinicians, including non-sonographer providers such as advanced practice providers (APPs), through the entire process at the point of care. The technology uses a real-time visual image quality meter to help the sonographer maintain proper positioning of the transducer, for example, and the advanced AI shows users how to get an optimal view and capture the images as needed. UltraSight said its technology enables reproducibility for FoCUS exams across care settings by reducing variability between users at the point of care.
FoCUS examinations are increasingly being used used for faster and more accurate patient triage. However, access to echocardiogram exams is limited by the availability of echo trained staff. This AI platform helps overcome the limitation by guiding anyone without specialized training who has basic knowledge on how to operate the ultrasound machine.
“What matters most is reliability at the point of care,” Harish Kinni, MD, assistant professor of medicine and emergency medicine at Mayo Clinic School of Medicine, said in a statement. “Having a standardized approach to image acquisition across devices helps reduce variation, improves efficiency, and supports better stewardship of echo resources across the health system.”
The company said the UltraSight Echo Stewardship Program helps expand effective imaging staff resources while preserving physician oversight for final interpretation and reporting. The new FDA clearance allows more available ultrasound systems from various vendors to utilize this software.
As point-of-care ultrasound (POCUS) continues to grow at a rapid pace, many clinician users are not experts in all types of exams, especially cardiac exams that require specific images at specific angles. This platform was developed to help flatten the leaning curve and increase the number of high-quality exams.
With this approval, UltraSight said it will work with health systems and device partners to bring expanded multi-device compatibility online.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]