Summary: Siemens Healthineers has received U.S. FDA clearance for the ACUSON Origin, a cardiovascular ultrasound system with AI features, and the AcuNav Lumos 4D ICE catheter. These technologies are designed to improve diagnostic accuracy and efficiency in cardiac procedures.

Key Takeaways:

  • FDA Clearance: Siemens Healthineers received FDA clearance for the ACUSON Origin ultrasound system, designed to improve cardiac diagnostics and procedures with advanced AI features.
  • AI-Powered Efficiency: The system provides over 5,600 AI-powered measurements and real-time cardiac view recognition, automating tasks to reduce cognitive workload and improve consistency.

The U.S. FDA has cleared Siemens Healthineers‘ ACUSON Origin, a cardiovascular ultrasound system powered by artificial intelligence (AI) features.

AI Features and Efficiency in Cardiac Care

The AI features are designed to help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart disease, and electrophysiology. Available exclusively with the ACUSON Origin, the new AcuNav Lumos 4D ICE (intracardiac echocardiography) catheter provides advanced imaging for complex heart procedures.

“With its advanced AI features and potential to enhance diagnostic accuracy as well as patient care, the ACUSON Origin is positioned to reshape healthcare’s approach to cardiovascular imaging,” says David Zollinger, head of cardiovascular ultrasound at Siemens Healthineers. “And the AcuNav Lumos is the latest milestone in our 24-year history with ICE. Since 1999, our ICE catheters have helped more than 2 million patients, reducing the need for anesthesia during procedures.”

The ACUSON Origin addresses cardiovascular patient care, including diagnostic, structural heart, vascular, electrophysiological, and pediatric procedures. It is designed to minimize the cognitive and ergonomic workload of cardiac exams and procedures, allowing for greater consistency, reproducibility, and user efficiency.

AI-Powered Measurements and Imaging Assistance

Its suite of AI-powered features for measurements, view recognition, and imaging assistance builds on the company’s AI development, which dates to the late 1990s. The AI features have been trained on an image database that contains over 2 billion annotated images. The features can save the user time on echocardiography procedures by providing automated measurements with accuracy and reproducibility.

ACUSON Origin is capable of more than 5,600 AI-powered measurements on transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). The system provides real-time cardiac view recognition. AI Assist, a new feature for TTE, recognizes cardiac structures and automatically positions color and spectral Doppler regions of interest when the transducer makes contact with the chest wall.

Advanced Imaging with AcuNav Lumos 4D ICE Catheter

The AcuNav Lumos 4D ICE ultrasound catheter introduces new features for improved procedural guidance. It allows treatment for patients who are not candidates for structural heart interventions due to TEE or general anesthesia contraindications, or tricuspid regurgitation. The catheter includes MPR biplane imaging, real-time 4D color Doppler, and 3D calipers for anatomical assessment and device guidance.