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Signify Premium Insight: FDA Approval for Samsung NeuroLogica as Interest in Photon Counting CT Grows

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Earlier this month, Samsung Electronics subsidiary NeuroLogica Corp announced that its new OmniTom Elite, with Photon-Counting Detector technology, has received FDA 510(k) approval. The approval means that NeuroLogica is the first vendor to have a 510(k) cleared, single-source mobile photon counting CT system in its stable.

The clearance also marks the next stage in the commercial growth of photon-counting CT, a much-lauded step which has long been considered to represent CT’s next technological milestone. A photon-counting CT detector can directly convert individual X-ray photons into electrical signals, which makes higher resolution and lower dose imaging possible. In receiving FDA approval for its detector, NeuroLogica becomes only the second vendor to be able to offer such a system commercially, after Siemens Healthineers received 510(k) approval for its own system in October 2021.

The Signify View

Many leading medical imaging vendors have had photon-counting CT squarely in their sights for several years. While Siemens Healthineers, with its 2021 clearance, has made the most commercial headway on the systems so far, its competitors are not far behind, with Philips, GE, and Canon among those vendors working on their own systems. There is also good reason for this focus, with the new technology promising higher image quality, better signal to noise ratio, higher resolution and lower dose than current CT technologies. In particular, the technology will help radiologists more clearly distinguish between different tissue types and the composition of different tissues, bringing benefits to a whole raft of use cases, from oncology and stroke care, to cardiovascular and pulmonary care.

However, these benefits are still some way off being realised at providers. Siemens’ commercially available system is still at the very first steps of adoption, with its price representing a significant barrier to purchasing for all but the best-funded research and academic hospitals. This premium price is, in part due to the fact that the new photon counting CT system sits at the top of the vendor’s CT range, positioning that will likely be mirrored by other large vendors when they release their own systems.

Samsung has however adopted a more unusual approach. The vendor has been making headway over the years with imaging modality sales, down in no small part to its aggressive pricing strategy whenever a large tender has been available. Whilst the specifics will be different for photon counting CT, the American subsidiary of the Korean conglomerate is still looking to make the adoption of the new technology a more palatable financial prospect. The vendor has highlighted that its new, FDA-cleared photon counting detector is available, not just as a stand-alone piece of equipment, but also as an optional upgrade to providers which have already recently purchased OmniTom CT scanners. This significantly reduces the cost of acquiring photon counting CT technology, making this technology more widely accessible.

A Gradual Plan

An upgradeable option will not only help bolster sales in the short term but should also help providers plan their transition to mobile photon counting CT. After all, instead of committing today, when the technology is still very young and the number of conducted studies and the volume of testimony about the technology is limited, a vendor can purchase one of Samsung’s non-photon counting systems safe in the knowledge that there is a clear upgrade path in future. As well as helping to ease its customers’ transition to a new technology, NeuroLogica is also using the new technology to help continue to carve out its own niche in mobile CT. This is important. With a handful of vendors dominating the traditional fixed CT market, a market in which it is difficult to gain traction and take market share from established competitors, NeuroLogica’s focus on mobile CT has helped it differentiate itself. As such its continued aim is to convince providers that OmniTom systems are needed in addition to, rather than instead of, other CT systems. Photon-counting technology could be powerful in this regard, helping to mitigate the reduction in image quality that is often the price to pay for having a mobile system.

This strategy isn’t without its own problems, however. One of the most significant barriers is encouraging providers that they need another CT system. While there may be some appetite for a system in a critical care ward, where patients quickly need imaging, and such a process could have a significant impact on patient outcomes, in non-critical care, providers are more likely to focus their budgets on more versatile fixed systems.

Whether NeuroLogica is able to overcome these challenges depends on the value it is able to offer providers with its new photon-counting CT system. In its press release, NeuroLogica mentioned that it is focusing on several use cases including stroke, trauma, intensive care and intra-operation imaging. While some of these seem unlikely targets, others, such as stroke care make sense, with the rapid detection of stroke critical to patient outcomes. Photon-counting CT does have advantages in this regard, with the technology’s improved image quality advantageous in stroke detection. Further, mobile photon-counting CT’s use in stroke detection could also benefit from the increasingly thorough stroke detection and triage AI tools from stroke care software developers such as Viz.ai and RapidAI, with such tools and mobile photon counting CT being mutually beneficial.

Ready and Waiting

More broadly, NeuroLogica’s FDA clearance is, like the research and developments from other vendors, not going to suddenly revolutionise the CT market, but it does highlight the interest and potential of the technology. Vendors will approach photon counting CT in different ways. Some such as Siemens have focused on cadmium telluride detector technology, while others, including GE have focused on using silicon-based detectors, with Mats Danielson, CEO of acquired company Prismatic Sensors insisting that the element’s purity sidesteps some limitations of cadmium-based systems.

In addition to the lack of convergence on technical aspects of photon counting CT technology, there is still ambiguity as to the best clinical applications of the technology, with even NeuroLogica, a vendor which has taken an original approach to the adoption of the technology, acknowledging that research in collaboration with partners will still be necessary in developing the full potential of its photon-counting OmniTom CT scanner.

For NeuroLogica then, the FDA approval does represent a significant milestone. What’s more, becoming only the second vendor to get cleared by the regulator is quite a feather in the firm’s hat, helping establish its credentials as an innovative company, as well as showing its intentions to be a key player in the PCCT market – albeit in its own way. This milestone will not instantly hasten the adoption of the technology, but it will bolster the vendor, letting NeuroLogica’s customers and potential customers know that when it comes to photon counting CT, it is ready when they are.

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This Insight is part of your subscription to Signify Premium Insights – Medical Imaging. This content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify ResearchTo view other recent Premium Insights that are part of the service please click here