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US-based imaging modality manufacturer Xoran has recently received FDA 510(k) clearance for its Tron open-bore mobile fluoroscopy CT system.

According to its maker, the system can complete scans in less than one minute, and is small enough to be easily manoeuvred around hospitals, as well as being able to fit in small vans, making it suitable for community health initiatives. The challenge for Xoran, however, is whether it will be able to gain significant traction given that fluoroscopy is for some clinical exams at least, falling out of favour.

The Signify View

For a relatively small company Xoran has made a surprising choice in targeting the fluoroscopy market. While it represents a sizable market, at over $500m in 2021, it is also a market that is undergoing fundamental change. Growth in the market, at 18%, was very strong as the market recovered from the previous-year’s Covid-induced lulls. Over the coming years the growth prospects look less robust, with the world fluoroscopy market forecast to grow at less than 4% CAGR between 2021 and 2026, as detailed in our General Radiography and Fluoroscopy X-ray Equipment – World 2022 report.

There are a number of reasons for this shallow growth trajectory. A growing number of procedures which would have traditionally been conducted on fluoroscopy systems are increasingly being performed on CT, MRI or endoscopy systems. The declining price points of these modalities, combined with clearer images, and declining dose levels for CT makes fluoroscopy a less attractive choice for many procedures.

Providers are also being more stringent in their requirements. Where a hospital may previously have had a dedicated fluoroscopy system, the need for providers to economise and maximise the use of their medical imaging hardware means that they are increasingly turning toward multiple purpose rooms. Such systems mean that providers aren’t forced to dedicate an entire room for fluoroscopy, which may be relatively underutilised, when instead they can use a multipurpose general radiography and fluoroscopy room, utilising a modality that is used significantly more frequently while still offering fluoroscopy exams as and when they are required.

Mobile Matters

Despite this disruption, Xoran’s Tron embraces some of these trends which could give it an advantage compared to other systems. The fact that it is mobile could be beneficial. In several modalities, including general radiography, mobile solutions are becoming utilised more frequently as they allow imaging exams to be conducted outside of the imaging departments that traditionally housed them, granting providers increased flexibility and enabling imaging examinations to be conducted in surgical rooms, emergency departments and critical care wards, for example. This could be particularly valuable for patients who are too sick to travel to a fluoroscopy room.

Xoran’s Tron also bucks trends in another way, utilising CT, rather than standard X-ray to capture the image. This improves the versatility of the system and enables it to be used as a CT system, providing advanced imaging in a range of settings.

Further, the flexibility offered by a mobile system gives providers the opportunity to better manage space within a hospital. Instead of a fixed system taking up valuable floorspace, a mobile system can be taken to where it is needed, when it is needed and moved away when it is not. This could be particularly beneficial at smaller sites and facilities which desire fluoroscopy capability, but do not have the space or budget for a traditional fluoroscopy room.

Capability Convergence

The release of a mobile fluoroscopy CT system also continues a broader trend in which the gap between digital radiography and CT systems is narrowing as the capability and sophistication of DR systems increase, and the expense and infrastructure requirements comes down, while other innovations such as computed tomosynthesis, also bridge the gap between the modalities. Such was the case for Nanox, which, in its initial promotional material, was unclear as to the exact nature of its Arc scanner. Xoran’s system continues this trend, representing a more affordable alternative to traditional CT fluoroscopy systems, while still offering much of the core capability.

Despite adhering to this growing trend, the company is still going to face many of the same difficulties facing other challenger vendors. Namely, the product offered while interesting, with some unique capabilities, and catering to some niche cases, will in many cases likely struggle to find buyers.

In developed markets, most providers are tightly linked to other, more established vendors. Such relationships make it seem unlikely that a provider, even if establishing a new community care health initiative, would take a risk on a relatively unproven company, when it could simply purchase a system from one of its established suppliers. This is particularly true given that Xoran’s Tron will most frequently be utilised for its CT rather than fluoroscopy capability, a modality that is already well catered for by larger vendors. Many of which also offer portable systems, that will, unlike Xoran’s Tron, also be able to benefit from some vendor-specific software systems. The vendor may find solace in dedicated screening programmes, for instance in lung CT, and has received grants from the US’s National Institute of Health to develop lung imaging capability, but again, other vendors would also be looking to capitalise on this market and are unlikely to give Xoran a free run.

Another Strategy Emerges?

These challenges in developed markets may lead Xoran to consider targeting emerging markets. This could prove to be a preferable strategy, with the Tron potentially representing a cost-effective opportunity for providers to acquire CT and fluoroscopy capability, in a package with minimal infrastructure requirements. However, the vendor would still face many of the hurdles that other vendors, both established and young disruptive vendors face in entering these markets, such as a lack of qualified staff and a shortage of sales and service networks.

Xoran may do better by demonstrating the efficacy of its tools, in clinical studies and use cases. While providers may be reluctant to commit to hardware from a relatively obscure vendor, providing clinical evidence of the touted advantages of the system could help attract providers’ interest.

Ultimately, however, for Xoran, as is the case for other smaller vendors with novel or niche solutions, such as Adaptix, Turner and Promaxo among others, the pace at which the medical imaging market moves must be considered. Adoption of new technologies is, by and large, slow. This could be particularly true for a vendor promoting an increasingly marginalised modality. This measured pace means that Xoran would do well to build its presence slowly. Its Tron system does have some advantages, but they are unlikely to be a purchasing priority for most providers. While it has enjoyed reasonable success with its focus on point of care imaging and claims to have installed over 1,000 CT systems since it was founded in 2001, the new Tron system is unlikely to be a major revenue driver for the company and its future success will likely come from other planned products. For example, if it is recognised in clinical guidelines as a reliable producer of screening equipment. However, to pin hopes on such a change would be overly optimistic.

Instead, the vendor should focus on the advantages it has, work to demonstrate them through clinical research, and look for ways to maximise them competitively, with AI partnerships, for example, offering one way for the vendor to add value to customers. It will be a slow road, but focused, deliberate action can make it navigable.

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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 Research. To view other recent Premium Insights that are part of the service please click here