Tag Archives: Mammography

Signify Premium Insight: US-FDA’s Standardised Appeal

Last month the US-FDA added a new rule to the Mammography Quality Standards Act, adding detail on the reporting of breast density in screening programmes.

The new guidance means that, from September 2024, breast screening centres will be required to notify patients about the density of their breasts, a physiological feature which can influence the accuracy of mammography and a risk factor for developing breast cancer. Providers will also have to convey this density information in specific, non-technical language.

The new rules also standardise the reporting of breast density, establishing four categories to identify breast density levels in the mammography report. Such federal guidance has been on the cards for several years, so what can be expected now it is enacted?

Signify Premium Inisght: Paying for AI – Artificial Intelligence and Genuine Costs

Radnet has announced that it is using AI to offer patients more detailed breast screening examinations as part of its Enhanced Breast Cancer Detection (EBCD) service. The new service will enable women attending their annual breast screening examinations to, for an additional fee, receive additional services which include the use of AI tools to assess a woman’s lifetime breast cancer risk.

EBCD utilises the Saige-Dx, a US-FDA cleared mammography diagnostic aid software from DeepHealth (a RadNet acquired company), adds an additional review applied to any suspicious

Signify Premium Insight: AI’s Personal Approach to Breast Imaging

Screening programmes are among the medical imaging use cases where, at least for the majority, there is little urgency. As such, they were one of the first casualties of the cancellations in response to the developing Covid-19 pandemic in 2020, as providers sought to stem the spread of the virus. While the rationale for such action was sound, now, almost three years later the consequences are being keenly felt.

According to Bhvita Jani, Medical Imaging Research Manager and co-author of Signify Research’s Breast Imaging Report – 2022, these consequences are having a significant impact on the breast imaging market, although there are some technologies that are coming to the aid of providers looking to address the challenges.

Signify Premium Insight: Screening Marks the Next Step in Intelerad’s Grand Ambition

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.

Intelerad added another company to its growing portfolio in August, acquiring breast and lung screening specialist PenRad Technologies. The acquisition of the vendor, which provides software to enhance the efficiency of screening programmes, is the latest in a string of purchases including Ambra Health, Insignia and Lumedx among others.

The deal, which was of an undisclosed value, will bolster Intelerad’s offerings for mammography and lung workflow tools and analytics. Its three core products, PenRad for breast imaging, PenLung from lung screening, and PenTrac for patient tracking and reporting will, according to Intelerad, help radiologists using its enterprise imaging platform to optimise workflows and manage screening programmes more efficiently.

The Signify View

Since Hg Capital became the majority investor in Intelerad in 2020, the vendor’s plans have, over time, become clear. Intelerad has set its sights on building out a fully-fledged enterprise imaging offering, a system that will cater to the needs of most providers and offer a genuine alternative to both other specialist imaging IT vendors as well as the solutions offered by larger international medical imaging vendors.

The acquisition will help in this regard. The integration of screening tools into the core imaging IT platform, while not unique, does add additional competency that will allow the firm to compete against some of the largest imaging IT providers. Furthermore, it will also help differentiate Intelerad from its current peer group of small and mid-size imaging IT “challenger” vendors. Such differentiation will also be particularly attractive to the outpatient sites that presently form the majority of Intelerad’s customer base.

Screening tools are also likely to increase in importance over time. Screening programmes in the US are well established for mammography, but are growing in sophistication, with increased uptake of more advanced modalities such as 3D mammography, ABUS and MRI, as well as additional reporting on harmonised diagnostic metrics such as risk scores and breast density. Another factor that could also mean providers are more willing to invest in tools such as those offered by PenRad are changes to reimbursement rates. Lower rates of reimbursement for screening mammography will increase the importance of screening efficiency. For screening providers, which rely on high volumes to drive revenues, any tools that enable greater reporting automation and more women to be screened, could therefore be very valuable.

In the US, Lung screening on the other hand is still underutilised, with patients often choosing not to participate in screening programmes when they are available. Despite this, the uptake of screening is still being encouraged, with, for example changes to screening rules making more people eligible to participate. Moreover, given the nascency of lung screening so far, PenRad’s lung assets will further differentiate the Intelerad offering.

Timing is Everything

The timing of the acquisition also makes sense. Following on from the Covid 19 pandemic, there has been a greater emphasis of care in outpatient settings. This is a market that Intelerad can serve effectively, although, without PenRad it lacks some of the specialist tools to be able to effectively capitalise on the requirements of screening providers. There are, for example, specialist workflow elements, registry integration requirements, and AI integrations which, among other needs, are distinct enough from typical radiology use cases to necessitate the acquisition if Intelerad is to succeed in the screening market.

While many PACS vendors offer some screening capability, these complexities mean that many informatics vendors also lack the specialist screening capability that Intelerad has acquired through its purchase of PenRad. In many cases, PACS vendors will “white-label” tools from vendors such as PenRad, or work with breast modality workstation vendors such as Hologic. Developing this capability in-house is not impossible for a vendor such as Intelerad, but it would have taken time to get right. By buying PenRad, Intelerad gets this capability right away, while also preventing any of its competitors picking up the firm.

The deal also makes sense for PenRad. While its tools are valuable, as a specialist company it is at risk of enterprise imaging vendors, whether smaller specialists or larger, broader imaging vendors and growing breast AI specialists increasingly encroaching on its turf as they too look to capitalise on the resilient screening market.

Acquisitive Ambitions

Despite the potential that the acquisition of PenRad offers in the outpatient and screening space, the capability it brings is not transformative for Intelerad, nor will it likely mark the end of the vendor’s acquisitive streak. Intelerad is, after all, focused on assembling a complete enterprise imaging solution, and, as long as Hg Capital is willing to support the vendor, Intelerad will look to make deals for the remaining gaps in its capability.

One such opening would be for digital pathology capability. While such tools are not yet necessitated by providers, they are, as discussed in a previous Premium Insight, increasingly looking for their vendors to be able to offer a plan which allows them to take advantage of digital pathology when they choose to. This requirement has led several imaging IT vendors to ensure they can meet this need, with Sectra and Philips offering the capability in-house, while the likes of Siemens Healthineers and Fujifilm have chosen to partner with Proscia and Inspirata respectively to offer the capability. Not to be outdone, Intelerad could choose to pick up a company focused on digital pathology and integrate it with its broader imaging IT offering. However, given the nascency of digital pathology, particularly in Intelerad’s key market of the US, partnering might represent a viable near to mid-term alternative as it has for Fujifilm and Siemens. Partnership is also an option that Intelerad is also willing to take, as illustrated by its partnership with Blackford Analysis for AI platform capability, for example.

Another area arguably more deserving of Intelerad’s focus is Advanced Visualisation (AV). Not only does this absence represent a gap compared to most of its peers, being able to offer AV capability would give the vendor a better chance of sealing deals at acute sites and helping the company expand beyond its core outpatient customer base. There are opportunities for Intelerad to offer white label solutions to customers, however, this route is more limited in terms of customisation and does not offer the same long-term certainty as offering solutions developed in house. Taking such an approach also means that Intelerad would not be able to keep all the revenues from the solution, a factor which could impede its ability to innovate in the future. Solving the “AV” challenge is not urgent, but as AV is increasingly de-coupling from modalities sales channels and gradually overlapping with AI image analysis tools, the firm will not want to wait too long without a clear plan of how to address the AV gap in its offering.

Acute Solutions

There are other capabilities that are also increasingly important, particularly if Intelerad has designs on the acute space. Many deals are now agreed on a long-term basis and include professional service and consulting elements. At present, Intelerad could miss out on some major contracts given that it is not among the vendors best placed to deliver on these requirements at scale and on multiple geographic fronts, a headache that has also challenged fast-growing peer Sectra. Other elements also important given growing pressures on imaging services are fleet management and operational analytics tools. Not only would such tools stand Intelerad in better stead as it competes for major deals with acute providers, but these allow the vendor to use them as a foundation to increasingly engage in lucrative service activities, helping providers realises their performance targets and meet their KPIs for example.

While adding these and other capabilities would not be cheap, if Intelerad were willing to invest the time and resource in fully integrating them, it would emerge with one of the most complete enterprise imaging solutions available. This in itself is no guarantee of long-term success; the imaging IT market moves slowly, and organic growth is hard to come by. As such, further acquisitions may be necessary for Intelerad to continue to gain market share and the revenues that it brings. However, the investment made by Hg Capital, along with additional investment from TA Associates, suggests that the vendor is not finished, and that more acquisitions are likely on the way.

The more pertinent question is how long HG continues to back Intelerad. It has proved its commitment in the near term, but at some point, it is likely to want to exit and realise a return. When this is, and how advanced the integration of its acquisitions is at this point is something that remains to be seen.

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

Signify Premium Insight: Breast Imaging: A Market Set for Change

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.

The nature of the breast imaging market makes it unlike almost all others. The fact that it is a market centred around national guidelines and screening programmes, which were almost universally paused as part of providers’ responses to the coronavirus pandemic, means that it has been disrupted more so than most others.

This disruption, and the long-term effect it is set to have on the market, as well as the impact of developing trends are detailed in the recently released Breast Imaging – World Market Report 2021.

For providers, the response to this disruption is likely to be varied.

“One statistic in the report,” says Senior Research Analyst and co-author Graham Cooke, “is that the UK’s National Health Service (NHS) expects it to take ten years to clear the backlog.”

“Because of this, if a healthcare provider does have the money to invest in new equipment and upgrade to new technologies then dealing with this backlog provides an incentive to do so. However, it could be the opposite. Breast imaging clinics could well have been stretched with regards to available budget over the previous year, and with restricted funds, they could continue to use the ageing installed base of equipment until there are funds available to replace them.”

 A Digital Direction

For some of these providers, however, the answer may not necessarily lie in the replacement of breast imaging hardware, but could focus on maximising the use of existing systems.  “That is really where AI could come in,” continues Cooke. “AI isn’t just about finding abnormalities on a mammogram that the human eye may miss, more practically some AI tools could help radiologists detect abnormalities more quickly, or rapidly give some cases a green light where no further attention is needed. This will mean that radiologists can focus their time on more urgent cases.”

While these tools could relate directly to image analysis, in practice, many of the solutions that are set to be of most use in clearing the backlog of postponed breast imaging exams focus their efforts elsewhere. Tools that facilitate operational workflow improvements or triage tools that help prioritise suspicious scans in the worklist are among those that offer the greatest benefit.

“Another interesting tool that will help in this regard is personalised screening and having AI assess a woman’s individual cancer risk, including factors like family history of breast cancer, genetics, lifestyle factors which make some people more at risk, or physiological factors like dense breast tissue.”

This will help providers manage their screening programmes, prioritising those who are most at risk, while individuals at lower risk of breast cancer can wait longer between mammography appointments, thereby reducing the provider’s workload.

This, however, will not happen immediately, cautions Senior Research Analyst Bhvita Jani. “At the moment there are still three main barriers to the widespread use of AI in breast imaging. Firstly, until it is included and recommended in national screening guidelines it is not going to make as much impact as it should.

“Secondly there is a lack of representation in the validation studies. There is, for example, an underrepresentation of some ethnic minorities which makes it impossible to extrapolate the findings to women of different backgrounds.

“The third problem is reimbursement. Unless AI is reimbursed the only way that providers would be convinced to use it is if it will reduce their costs.”

The breast imaging AI market is set to grow rapidly as the barriers to its adoption are overcome

Starting Screening

Another factor that could dramatically impact the breast imaging market is the establishment of screening programmes in countries that don’t yet have them. The growth potential for different vendors in the breast imaging market is highly dependent on the country dynamics.

“China, for instance, is quite a price-sensitive market,” notes Cooke, “so even if it were to introduce a screening programme, that screened millions of women, providers would overwhelmingly purchase their systems locally. Not only do Chinese vendors have lower price points than international vendors, but Chinese hospitals often have partnerships with local vendors. Going with a local brand will also often be seen favourably, compared to using an American or European brand for example.”

Jani adds: “But, this would only be the case for 2D mammography systems. Any demand for 3D systems will still primarily be captured by global vendors as Chinese vendors don’t extensively offer 3D systems.

“In some areas that are on the cusp of establishing screening programmes global vendors will be preferred. In the Middle East region, for example, where brand reputation is very important. Screening programmes in other areas could also benefit global vendors, including several CIS (Commonwealth of Independent States) countries. However, within this market, there is a stronger preference for low to mid-range breast imaging systems.

“It is worth noting though, that when it comes to large government tenders, price is often the most important consideration. So, companies that are more flexible when it comes to price negotiations have tended to do well. One company that has been particularly successful is Fujifilm. It has increased its share of the mammography market, through, in part, its aggressive pricing strategy.”

 Demand for More Dimensions

For those countries that already have established breast screening programmes, there are still some large and impactful changes on the horizon.

“One of the biggest unanswered questions in the breast imaging market is when will 3D mammography be used outside of the US for screening, which is the only country to have so far really embraced the technology,” Jani explains. “Our prediction is maybe three to five years for Western Europe, which looks set to be one of the next markets to adopt 3D for breast screening.

“This rollout of 3D mammography can only take place when there is enough provision to read the 3D scans, with limited radiologist capacity being a challenge. Because of this, the rollout of 3D will likely go hand in hand with the increased adoption of AI, which will help providers make the transition by reducing the time required to read 3D scans.”

Digital Breast Tomosynthesis is forecast to grow strongly over the coming years

There could also be other technology changes afoot. “There are a number of different emerging breast imaging technologies becoming available,” notes Cooke, “but mammography is still the dominant, unthreatened modality by far.”

“Other modalities, such as ABUS or Cone Beam Computed Tomography have advantages compared to mammography in some ways, but it is difficult for them to penetrate the breast imaging market. “These technologies are not designed to replace mammography but are instead meant to supplement it. They must work alongside mammography to be part of patient pathways. If you consider automated breast ultrasound, for example, that has taken some 20 years or so to really be accepted, and even now there are only a handful of vendors that offer it.

“So, we could see some of these smaller and more niche breast imaging vendors getting acquired by larger breast imaging vendors. There are already examples of this, with Hologic, which dominates the mammography market, diversifying their hardware portfolio to include breast ultrasound, by recently acquired Supersonic Imagine, whose technology should complement Hologic’s own mammography systems.”

Women’s Priorities

There are other changes that will affect providers’ purchasing decisions in the nearer term. For screening mammography at least, screening centres are in competition with one another, in particular in the United States, for footfall of eligible women. Because of this, vendors will happily pay to purchase new and higher-end systems, with features which focus on the patient experience and comfort, if they will attract more women into their centres.

“One-way providers are encouraging more women into their screening programmes is by focusing on enhancing comfort levels, and reducing discomfort and pain,” notes Cooke. “That could have a large role in influencing what systems providers actually purchase.

“This is a prominent trend and as a result, instead of only marketing their systems to providers, breast imaging vendors are targeting women directly. The preferences of these women could then influence what systems providers purchase.”

The Market Matters

These sorts of strategies are only viable in countries where screening programmes are already established. While there will be effort expended to encourage women to participate in screening programmes, for vendors and providers in these countries the priority will be on improving the patient experience and the accuracy of first-time right screening and reducing the rate of rescans and recalls.

“Over the coming years, there will be more focus on personalised screening and risk-based screening, as well increased variation in the breast imaging modality used and the frequency of scans,” details Jani. “These changes could also be very much influenced by AI’s development in this market.

“In developing countries, the creation and establishment of screening programmes will be the biggest change. But this is itself dependent on the subsequent treatment plan that is available afterwards is a diagnosis is made”.

“Overall, though, the next 10 years could really shake up the breast imaging market. New emerging breast imaging technologies could gradually have increased market adoption where there are established screening programmes. Meanwhile there will be some opportunity for niche vendors to increase the uptake of their products and get their systems installed as part of new screening programmes where guidelines are yet to be established.

“It is, after all, easier to penetrate a new market with a lack of guidelines and recommendations, than it is to try and break a well-established market like the US right away.”

The breast imaging market is set for change. Technological developments, primarily in breast AI, will play a part in enabling this change and drive increased uptake of more advanced breast imaging hardware solutions. With current challenges such as the significant backlog of women requiring screening, a fundamental need to reduce the number of false positives or negatives and the need to increase early detection and more accurate diagnosis all being factors that will help drive this movement forward.

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