FDA OKs GE HealthCare’s Voluson Expert Series Ultrasounds

GE HealthCare has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for the updated portfolio of Voluson Expert Series ultrasound systems.

The series, which includes Voluson Expert 22, 20, and 18, integrates artificial intelligence (AI)-powered features and automation tools to boost imaging performance and efficiency in women’s healthcare, GE HealthCare said.

The new products’ premium ultrasound imaging aim to facilitate confident diagnoses for high risk, complex pregnancies. Their Lyric Architecture was designed to unlock new imaging and processing power for detailed and uniform images, as well as revealing finer anatomical details in difficult scanning conditions.

The SonoLyst suite of tools offer image recognition and automated annotations and measurements. Clinicians can use SonoLystlive during 11 to 14-week anatomical exams to help ensure required views are captured for diagnostic accuracy. The ultrasound systems also feature an expanded color Doppler offering, Graphicflow, which provides a graphical representation of the blood cells’ trajectories in real-time to visualize complex blood flow quickly and clearly, helping differentiate normal from abnormal hemodynamics.

SonoPelvicFloor3.0 can help reduce pelvic floor measurement exam time by 80% versus a manual exam. This feature now expands anatomical views, and simplifies the exam process by automating plane alignment, live C-plane tracking, and measurements. SonoAVCfollicle2.0 uses AI to increase accuracy and precision in follicle detection, resulting in a better success rate of detecting follicles, along with reduced artifacts and requiring less time for postprocessing.

The systems are compatible with a new lightweight 2D/3D probe RAB7-D, and wireless Vscan Air dual probes.

“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,” said Gerald Seifriedsberger, General Manager, Women’s Health, Advanced Visualization Solutions, 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 healthcare. Together, we can create a healthier future for all women.”