Tag Archives: Samsung

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

This Insight is part of your subscription to Signify Premium Insights – Medical ImagingThis 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.

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.

About Signify Premium Insights

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

Signify Premium Insight: Vendor Financials Roundup – The Health of the Imaging Sector Q4 2021

This Insight is part of your subscription to Signify Premium Insights – Medical ImagingThis 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.

Although 2021 may seem a distant memory, vendors’ performances in its final quarter, along with the circumstances which shaped them, offer mixed fortunes for medical imaging’s biggest companies in 2022.

The quarter’s results showed some continuing reticence as a result of the coronavirus pandemic’s ongoing disruption, with new variants causing further headaches for vendors and providers alike. More broadly however, vendors’ results were mixed. Many fell into the ‘unremarkable’ category, such as Philip’s Diagnosis and Treatment business, and Nuance’s Healthcare business. These vendors were able to deliver low single digit revenue growth over the quarter, enough to appease, but not delight, investors.

Other vendors had more dramatic quarters. Fujifilm presents the highest quarterly growth compared to the same quarter in 2020, with a huge 47% increase, including a 56.7% increase in its Medical Systems business. The vendor did have a good quarter, noting in particular the demand for its ultraportable digital X-ray imaging systems and ultrasound systems, however much of this growth was only on paper as a result of turning Fujifilm Healthcare, which includes Hitachi’s diagnostic imaging business, into a consolidated subsidiary. Other standouts were Siemens Healthineers’ Imaging segment, which posted revenues 12% higher at EUR2.53bn, and Change Healthcare which posted revenues 10% higher than a year ago at $866m. Sitting at the other end of the spectrum was GE Healthcare and Shimadzu Medical Systems, which saw revenues fall by four and six percent respectively.

The Signify View

One of the central factors determining how vendors performed in the quarter, stemmed from their response to one of the quarter’s most significant challenges; the immense disruption to supply chains. This disruption and its impact was highlighted by many vendors, and, as explained in Signify Research’s Q321 analysis, its management would be among factors that defined their performance.

These differing approaches were apparent in the vendors’ financial figures. Siemens Healthineers revenue growth of 12% looks good on paper, but this came at the cost of the vendor’s margins. Siemens’ Imaging EBIT margin was still strong at 20%, but this was 340 basis points below those of the prior year quarter. Looking ahead the vendor said that margins would continue to be affected throughout 2022, with the most significant impact to be felt in the first half of the fiscal year.

Essentially, Siemens has shouldered much of the increased costs caused by supply chain disruption and component shortages. Philips also saw margins decline, falling from 14% to 13% on an adjusted EBITDA basis, however, comparable sales growth was flat, suggesting that the vendor was less willing to absorb the additional expense in a bid to protect margin. The vendor claims that this hasn’t cost it any business. It has, however, reported double-digit growth in the order book for its Diagnosis & Treatment business, implying that the vendor is enjoying similar demand to its German competitor, but could be less willing or able to spend more on fulfilling those orders immediately, instead choosing to wait to convert them into sales, but, hopefully, without sacrificing margin.

GE Healthcare also appears to fit this mould. At $5.3bn, the segment enjoyed a 7% increase in orders, however these future sales are contrasted by a 4% fall in revenue to $4.6bn, an 18% drop in profit to $800m and a 290 base point decline in margin to 16.5%. Another vendor fitting a similar pattern is Canon, which, in its Medical segment, saw net sales increase by 4.6%, but profit fall by 20% from 10.3bn Yen to 8.2bn.

Of course, these headwinds didn’t impact all vendors equally. Supply chains and logistics are obviously of less importance to vendors focused on software and imaging IT, a fact borne out by Change Healthcare and Sectra’s Imaging IT Solutions group, showing strong results, with revenues 10% and 7% higher respectively.

Expanding Inflationary Pressures

These supply chain difficulties also come amid global inflationary pressures. Many of the tracked vendors have increasingly been moving clients onto longer and ever more comprehensive managed service contracts. While this brings stability, with providers tied into deals for extended periods, vendors may lack the flexibility to raise their prices, despite facing higher costs themselves. While these eventualities will have been somewhat priced into deals, it could hurt vendors’ margins over an extended period. Such effects would hit those vendors who have most readily adopted these sorts of deals hardest, but, it could also have knock-on effects further in the future, as providers coming to the end of a managed service contract could find themselves suddenly hit with a dramatic increase in costs. Effectively being forced to stomach several years of inflation all at once.

Some vendors will also benefit from more positive currents over the coming years. Fujifilm and Canon, which are strongest in their home nation of Japan, were well supported throughout the pandemic by the Japanese government, which invested strongly in order to bolster the nation’s ability to fight the pandemic. Canon and Fujifilm benefited from this spend both in the near term, with hospitals acquiring additional systems for use in Covid care but are also likely to reap rewards for years to come, with the possibility of additional service revenues and upsell opportunities stemming from those additional hardware sales and expansion of their installed bases.

More broadly, vendors offered limited commentary about less developed markets. Philips noted that its Diagnosis and Treatment business enjoyed double-digit growth in Latin America and India, as well as mid-single-digit growth in China, but otherwise information was limited. This absence suggests that for most vendors, performances in emerging markets, excluding China, were neither remarkable, nor an area of particular focus. This makes sense. Although there is potential in these markets in the future, at present, the lower vaccination rates among their populations, the proportionately higher costs of tackling the pandemic compared to more developed regions, and wider pandemic-induced economic instability means that these are poor areas on which to focus, particularly when so much attention is required to deal with the challenges in their core markets. Vendors need to ensure resources are delivered to their highest-margin products, particularly in instances where they have had to absorb additional costs.

Fighting Fires

Headwinds facing the tracked vendors are, in many cases, more severe than they have been over the preceding few quarters, but, for the most part vendors are doing a fair job of managing them. Judging solely by the fourth quarter results (for those that have published at time of writing), vendors have, to a greater or lesser extent, been able to mitigate the impact of the headwinds by shouldering costs themselves, pushing out installations and sales, and relying on their service sales and add-ons to drive revenues.

These are primarily defensive moves, which see the tracked vendors protecting their revenues, and protecting their customer bases. Expending effort on such defence will naturally mean that these companies will have less capacity with which to address their longer-term objectives, meaning that advances in broader industry directions such as precision medicine, AI and digital twinning, for example, could be delayed. There are tailwinds that are set to offset some of these headwinds. If vendors can service demand, then the enormous backlog of elective procedures will provide a boon to those vendors who offer interventional imaging and therapy technologies, these will be strong growth drivers. Other vendors will see changes in some product categories offset changes in others. CT, for example was used heavily in Covid care, so the improving coronavirus situation will see demand for new systems diminish, however, this will be somewhat offset by increases in MR system sales, which were dampened during the pandemic.

The culmination of these various factors means that 2022 will be a challenging, albeit manageable year. Instead of being able to focus on long-term ambitions, vendors must be reactive and dynamic, shifting their resources to deal with the issues of the moment. Several vendors have suggested that supply chain conditions will improve in the second half of 2022, at which point increasingly normal service will resume. Until then, however, the vendors that perform the most strongly, are likely to be those that can most effectively juggle this breadth of challenges, without dropping any important balls.

About Signify Premium Insights

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