Siemens gets FDA clearance for 'major' improvement to CT imaging

Dive Brief:

FDA has granted 510(k) clearance to a Siemens Healthineers' diagnostic imaging device designed to boost the spatial resolution of computed tomography while reducing the dose.
The product, which FDA hailed as the "first new major technological improvement" in CT in nearly a decade, brings the photon-counting detectors already used in some other areas of imaging to X-ray computed tomography. The device's photon-counting detectors measure each individual X-ray that passes through a patient's body, as opposed to current systems that use detectors measuring the total energy contained in many X-rays at once, providing more detailed information about the patient that "can be obtained and used to create images with less information that is not useful," according to FDA.
Siemens expects the technology to "improve clinical value by significantly enhancing image quality." While Siemens has first-mover advantage in the marketplace, its rivals are gearing up to enter the field, with GE Healthcare signaling its intent last year by acquiring Prismatic Sensors.

Dive Insight:

Current CT systems use a two-step process to turn absorbed X-rays into an image. The X-rays are first converted into visible light, which is then turned into an electrical signal. Photon-counting detectors skip the first conversion step, instead directly turning X-ray photons into electrical signals.

Advocates of the one-step X-ray conversion process point to a range of potential benefits, including smaller detector pixel sizes, improved contrast between soft tissue and contrast material, and the exclusion of electronic noise on images. As the detector pixels are smaller, radiation dose efficient imaging at high spatial resolutions becomes possible.

Early tests of photon-counting CT technology have been well received by healthcare professionals, with a physician at Mayo Clinic calling the cardiac images it generates "incredible" as they reveal "structures that were simply too small to be resolved with previous detector technologies."

Siemens has talked up the opportunity on recent quarterly result conference calls with investors. On the calls, Siemens Healthineers CEO Bernd Montag said the first results from clinical use test sites "look very, very promising" and quoted an early user who is "convinced every CT will be a photon-counting CT."

GE Healthcare has made equally bullish predictions about the prospect of photon counting becoming the standard for all clinical applications of CT. Siemens has landed 510(k) clearance ahead of its rivals but competitors are on the horizon.

The new product, called Siemens NAEOTOM Alpha, slots into a fast-growing part of the company's business. Over the first three quarters of its 2021 fiscal year, Siemens' imaging division generated sales of €6.9 billion ($8.0 billion). The figure marked 7% growth over the comparable period of 2020, which was negatively affected by COVID-19, and a 12% increase over the first three quarters of 2019.