FDA Clears New Photon-Counting CT Systems from Siemens Healthineers

Siemens Healthineers received FDA clearance for the Naeotom Alpha.Pro, the company’s second dual-source CT scanner, and the Naeotom Alpha.Prime, a single-source scanner with photon-counting CT technology. Since 2021, the Naeotom Alpha has been the only commercially available system with this technology for clinical use, and more than 1 million patients have been scanned worldwide. Now called the Naeotom Alpha.Peak, this pioneering dual-source scanner will remain part of the Naeotom Alpha product class as its most premium member.

“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.

Photon-counting CT registers each individual X-ray photon that passes through the patient to enable the acquisition of more detailed anatomical images with functional information. Clinicians can evaluate small structures precisely and with fewer artifacts using lower radiation doses than conventional CT scanners. By maximizing diagnostic information and accuracy with photon-counting CT, they can make decisions quickly and enjoy optimized workflows.

As the high-end model of the new scanner class, the Naeotom Alpha.Peak delivers the fastest scan speed of 737 mm/sec (millimeters per second) for radiologists who require a high level of clinical performance. Like the other two scanners in the class, it uses the resolution of Quantum HD technology to display anatomy with a previously unseen level of detail at a slice thickness of 0.2 mm. This technology makes small abnormalities visible without increasing the patient radiation dose.

The Naeotom Alpha.Pro also combines the precision of photon-counting with the speed of dual-source, enabling scan speeds as fast as 491 mm/sec with the same 66 ms temporal resolution as the Naeotom Alpha.Peak. This speed can impact pulmonology, with patients needing to hold their breath for less time; pediatrics, with children potentially not requiring sedation; and cardiology, with patients potentially not requiring beta-blockers to slow their heart rate. The scanner’s dual-source capabilities support complex tasks such as the automatic analysis and evaluation of highly calcified coronary arteries as well as time-critical treatments for stroke and trauma.

The Naeotom Alpha.Prime, with a scan speed of 345 mm/sec, delivers high-performance photon-counting in a single-source CT scanner designed for in-patient, ambulatory, and emergency-room examinations, making the technology available for a wider variety of facilities. Like all Naeotom Alpha class models, the Naeotom Alpha.Prime uses artificial intelligence and automation to accelerate diagnostic and interventional processes. For example, the myExam Companion intelligent user interface provides guidance through each step of the examination—from system and patient preparation to image acquisition and reconstruction, as well as evaluation and post-processing. This assistance helps institutions achieve consistent results quickly and easily, regardless of patient group, procedure, or user experience.