FDA Clears Siemens Healthineers’ Innovative Technology
Siemens Healthineers has achieved a significant milestone with FDA clearance for its groundbreaking Naeotom Alpha class of photon-counting computed tomography (CT) scanners. This revolutionary technology represents a major advancement in medical imaging, providing unprecedented detail while reducing radiation exposure for patients.
Expanding Access to Advanced Imaging
The newly cleared Naeotom Alpha class includes three distinct models designed to meet various clinical needs and facility requirements:
- Naeotom Alpha.Peak: The premium dual-source scanner offering the fastest scan speed at 737 mm/sec
- Naeotom Alpha.Pro: A second dual-source scanner with scan speeds up to 491 mm/sec
- Naeotom Alpha.Prime: A single-source scanner making this technology accessible to more facilities
Since its introduction in 2021, the original Naeotom Alpha (now called Alpha.Peak) has successfully scanned over one million patients worldwide, demonstrating both clinical efficacy and patient safety.
How Photon-Counting CT Works
Unlike conventional CT scanners, photon-counting technology registers each individual X-ray photon passing through the patient. This innovative approach enables:
- Acquisition of more detailed anatomical images with functional information
- Precise evaluation of small structures with fewer artifacts
- Lower radiation doses compared to traditional CT scanning
Clinical Benefits and Applications
The exceptional imaging capabilities of these scanners deliver significant advantages across multiple specialties:
Pulmonology
Patients benefit from shorter breath-hold times, improving comfort and image quality during lung examinations.
Pediatrics
Faster scanning may eliminate the need for sedation in young patients, reducing risks and improving the care experience.
Cardiology
The scanners’ temporal resolution of 66 ms potentially eliminates the need for beta-blockers to slow heart rates during cardiac imaging. The technology also supports automatic analysis of highly calcified coronary arteries.
Emergency Medicine
For time-critical conditions like stroke and trauma, the enhanced speed and detail can significantly impact treatment decisions and patient outcomes.
AI-Powered Intelligence
All Naeotom Alpha class models incorporate artificial intelligence and automation to streamline workflows. The myExam Companion intelligent user interface guides technologists through each step of the examination process:
- System and patient preparation
- Image acquisition and reconstruction
- Evaluation and post-processing
This AI assistance helps facilities achieve consistent, high-quality results regardless of the operator’s experience level.
Expanding Healthcare Access
“By introducing our Naeotom Alpha class of photon-counting CT scanners, Siemens Healthineers delivers on what we see as our responsibility: to broaden the availability of this technology and enable customers to provide its clinical benefits to as many clinicians and patients as possible,” said Matthew Dedman, Head of Computed Tomography at Siemens Healthineers North America.
With the Naeotom Alpha.Prime specifically designed for in-patient, ambulatory, and emergency room settings, this revolutionary imaging technology is now accessible to a wider range of healthcare facilities, potentially transforming diagnostic capabilities across the medical landscape.
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