FDA Clears AI-Enhanced Portfolio of Ultrasound Systems for Women with High-Risk Pregnancies

The Food and Drug Administration (FDA) has granted 510(k) clearance for artificial intelligence (AI) updates to the Voluson Expert Series of ultrasound systems geared toward examination of women with high-risk pregnancies.

New AI-enabled features with the Voluson Expert 22, 20 and 18 ultrasound systems include SonoLystlive, which facilitates increased accuracy for 11 to 14-week anatomical exams, and Graphicflow, which offers real-time visualization of blood flow trajectory that aids in detecting abnormal hemodynamics, according to GE HealthCare, the manufacturer of the Voluson Expert ultrasound platforms.

The company said other benefits include live C-plane tracking and automated plane alignment with SonoPelvicFloor^3.0, which reportedly decreases exam time for pelvic floor measurement by 80 percent.

“We are proud to introduce these updates to the Voluson Expert ultrasound systems, which represent our ongoing commitment to advancing technology that addresses women's health needs of today, and the future,” noted Gerald Seifriedsberger, the general manager for Women’s Health, Advanced Visualization Solutions at GE HealthCare. “By introducing solutions that offer unparalleled clarity and detail, we can empower users with critical insights for informed care decisions and efficient exams, transforming how clinicians approach health care.”