Signify Premium Insight: FDA Approval Lets Siemens Make CT Count
Published: November 4, 2021
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In a recent announcement, the FDA revealed that 510(k) clearance has been awarded to Siemens Healthineers’ NAEOTOM Alpha, marking the first time a photon-counting CT (PCCT) device has been approved for clinical use by the regulator. Photon-counting technology has long been a target for CT imaging development, with a number of vendors including Philips, GE and Canon all working to build their own solutions, however, thus far, only Siemens has succeeded in developing a system that is ready for market. With FDA clearance now in hand, Siemens can look ahead to the scanner’s official launch later this year.
Key to Siemens’ system is its photon-counting detector. Unlike a typical CT detector which measures the total energy passing through a patient’s body, gathered from multiple X-rays simultaneously, Siemen’s photon-counting detector measures each individual X-ray that passes through the patient to create 3D images. In doing so the PCCT system is able to produce images with more detail, greater contrast and less noise compared to traditional systems.
The Signify View
It is rare for the FDA to make comment on the products it approves for clinical use. However, the body broke with tradition in order to highlight the significance of the approval, with the FDA’s Assistant Director at the Diagnostic X-ray Systems Team, Lauren Burk PHD, noting that photon-counting CT was the “first major new technology for computed tomography imaging in nearly a decade.” With such a sterling endorsement, can Siemens (as well as other vendors when their own scanners become available) look forward to making a sizable impact as customers start to purchase the systems?
There are some compelling clinical reasons why providers will be interested. Fundamentally, using a photon-counting CT system will provide radiologists with more data, which it is hoped will translate into earlier and more accurate diagnosis. PCCT achieves this through better spatial resolution, giving medical images greater sharpness and clarity, while improving the contrast to noise ratio of medical images. This improved spatial resolution is also combined with spectral information. This spectral information is included in every scan without dedicated operating modes or specific settings being selected. Significantly, this additional information is also included without any compromises in terms of scan speed or operating efficiency, which means that radiologists will be able to access and utilise the data more readily. As well as these imaging improvements, photon-counting CT also offers advantages in terms of dose efficiency.
Areas of Interest
These qualities give PCCT solid clinical advantages in some areas. Siemens, for example, expects its system to have a dramatic impact in oncology, where it can facilitate better disease characterisation. This will improve the diagnosis in the beginning, but also improve assessment throughout a patient’s care journey and therefore enable doctors to make better treatment decisions. Other applications can have a more direct impact. While CT imaging is well suited to rule out coronary artery disease in relatively large normal vessels, its specificity remains low. For patients with calcified plaque, a further limitation of standard CT is that blooming artifacts can limit accurate evaluation. In these situations, doctors will have to turn to an invasive diagnostic procedure, which, aside from being more burdensome for the patient, is more expensive and carries more risk. PCCT will be able to avoid the necessity for this catheterisation in many situations as the improved spatial resolution will increase the specificity of CT imaging. This change to the clinical pathway for some patients, as well as the associated financial benefits, are compelling reasons for providers to upgrade to the system. Another use case may be pulmonology, where the sharper images associated with PCCT could lead to improved diagnosis of lung diseases. With Siemens currently being the only vendor to have an approved solution, depending on when a provider’s systems are due for an upgrade and how soon comparable systems from other vendors become available, the German company could leverage its competitive advantage to expand its market share, potentially enticing customers away from its competitors.
The Move to Market
Of course, it will not be possible for such benefits to be conferred freely. Technical innovations typically come at an increased price, and such is the case with Siemens’ upcoming PCCT system. However, the NAEOTOM Alpha is not designed to address only a very specific niche market, but is instead targeted more broadly. The system does command a premium, while Siemens has not announced pricing it is expected to be at around 50% more than a current high-end scanner. While this differential in price is not insignificant, for well-funded providers which can expect to save money over the long term through the use of PCCT it is also not prohibitive. Over time, however, PCCT scanners are likely to become an integral part of a vendor’s portfolio, meaning that, while they will not occupy the value end of a vendor’s offering for the foreseeable future, prices for the technology do look set to gradually fall. In addition to the higher cost of the photon-counting detector itself, the scanner requires considerably more computing power to process the vast amounts of data generated. The cost of this processing power will also inevitably fall in the coming years. Competition from other vendors, as their own systems are released will also expedite this process.
When competitors will release comparable products, however, remains to be seen, but several vendors are known to be working on them. Philips, has a prototype device in Lyon that is currently being utilised in studies, with recent research evaluating its spectral photon-counting CT’s performance against that of a dual-layer CT scanner. Other vendors are also making moves, with GE Healthcare last year buying up Swedish firm Prismatic Sensors, a company which specialises in the development of photon counting CT detectors. Canon has also taken this acquisitive approach, and earlier this year sprung for Redlen Technologies. Redlen’s expertise lies in the development and manufacture of cadmium zinc telluride, one of the key materials used in the manufacture of photon counting CT detectors. Not only will bringing Redlen in house give Canon more stability over its sourcing of cadmium zinc telluride, but the move could also give Canon more control and traceability with regards to the quality of the material. After all, impurities or inconsistencies, as well as yields, will all have an impact on the ultimate success of the vendor’s PCCT scanners when they are launched.
The fact that the FDA commented on the progress Siemens has made in terms of its CT capability is telling, while the fact that the German vendor has, for the time being, the market to itself places it in a very strong position. However, it must capitalise on this opportunity. Selling replacement systems of a higher price to existent customers is a valuable target. But, given the potential of photon counting CT to be used in new applications, Siemens should also be looking to sell additional systems to its customers, and encourage them to bring their upgrades forward. At first, this may be very much focused on the larger academic and specialist hospitals, but over time, if the advantages are as significant as Siemens claims, then a broader range of providers could also be interested. As well as targeting its own customers, Siemens should also look to capitalise on its present competitive advantage and try to make its case to those providers whose custom usually goes to Siemens’ competition. Not only would this mean additional sales for Siemens, but, getting its flagship CT technology into other providers could also bring the chance to upsell as well as additional opportunities when those providers are looking to purchase additional imaging systems.
Other vendors, meanwhile, need to focus on the development of their own systems to minimise the amount of time that Siemens has the market to itself. Beyond this, they should also reassure their customers that a comparable system is on its way, and highlight any comparable functionality already possessed by their systems. In its promotional material for its recently released Spectral CT 7500, for example, Philips also boasts of the system’s ability to deliver spectral imaging on every scan, without the need for additional protocols.
Medical imaging procurement moves slowly, brand loyalty is important to hospitals, and increasingly providers are tied into broader, ever more encompassing medical imaging deals. However, Siemens’ development of PCCT before any other vendor has given it an opportunity to increase both its market share, and its mind share. The question is, can it take advantage?
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