Tag: artificial intelligence

Reimbursement Drives AI Adoption

Posted on by Brian Casey

It’s no secret that insurance reimbursement drives adoption of new medical technology. But a new analysis in NEJM AI shows exactly how reimbursement is affecting the diffusion into clinical practice of perhaps the newest medical technology – artificial intelligence. 

Researchers analyzed a database of over 11B CPT claims from January 2018 to June 2023 to find out how often reimbursement claims are being submitted for the use of the over 500 AI devices that had been approved by the FDA at the time the paper was finalized. 

  • The authors chose to focus on CPT claims rather than claims under the NTAP program for new technologies because CPT codes are used by both public and private payors in inpatient and outpatient settings, while NTAP only applies to Medicare inpatient payments. 

They found 16 medical AI procedures billable under CPT codes; of these, 15 codes were created since 2021 and the median age of a CPT code was about 374 days, indicating the novelty of medical AI.

  • Also, only four of the 16 had more than 1k claims submitted, leading the authors to state “overall utilization of medical AI products is still limited and focused on a few leading procedures,” such as coronary artery disease and diabetic retinopathy.

The top 10 AI products and number of CPT claims submitted are as follows:

  1. HeartFlow Analysis for coronary artery disease (67,306)
  2. LumineticsCore for diabetic retinopathy (15,097)
  3. Cleerly for coronary atherosclerosis (4,459)
  4. Perspectum LiverMultiScan for liver MRI (2,428)
  5. Perspectum CoverScan for multiorgan MRI (591)
  6. Koios DS for breast ultrasound (552)
  7. Anumana for ECG cardiac dysfunction (435)
  8. CADScor for cardiac acoustic waveform recording (331)
  9. Perspectum MRCP for quantitative MR cholangiopancreatography (237)
  10. CompuFlo for epidural infusion (67)

While radiology may rule in terms of the sheer number of FDA-approved AI products (79% in a recent analysis), the list shows that cardiology is king when it comes to paying the bills. 

The Takeaway

Amid the breathless hype around medical AI, the NEJM AI study comes as a bit of a wake-up call, showing how the cold reality of healthcare economics can limit technology diffusion – a finding also indicated in other studies of economic barriers to AI. 

On the positive side, it shows that a rosy future lies ahead for those AI algorithms – like HeartFlow Analysis – that can make the leap.

Accessing Quality Data for AI Training

Posted on by Partner Content

One of the biggest roadblocks in medical AI development is the lack of high-quality, diverse data for these technologies to train on.

What Is the Issue with Data Access?

Artificial Intelligence (AI) has emerged as a game-changer in the realm of medical imaging, with immense potential to revolutionize clinical practices. AI-powered medical imaging can efficiently identify intricate patterns within data and provide quantitative assessments of disease biomarkers. This technology not only enhances the accuracy of diagnosis but can also significantly speed up the diagnostic process, ultimately improving patient outcomes.

While the landscape is promising, medical innovators grapple with challenges in accessing high-quality, diverse, and timely data, which is vital for training AI and driving progress.

A 2019 study from the Massachusetts Institute of Technology found that over half of medical AI studies predominantly relied on databases from high-income countries, particularly the United States and China. If models trained on homogenous data are used clinically in diverse populations, then it could pose a risk to patients and worsen health inequalities experienced by underrepresented groups. In the United States, If the Food and Drug Administration deems these risks to be too high, then they could even reject a product’s application for approval. 

In trying to get hold of the best training data, AI developers, particularly startups and individual researchers, face a web of complexities, including legal, ethical, and technical considerations. Issues like data privacy, security, interoperability, and data quality compound these challenges, all of which are crucial in the effective and responsible utilization of healthcare data.

One company working to overcome these hurdles in hope of accelerated and high-quality innovations is Gradient Health.

Gradient Health’s Approach

Gradient Health offers AI developers instant access to one of the world’s largest libraries of anonymized medical images, sourced from hundreds of global hospitals, clinics, and research centers. This data is meticulously de-identified for compliance and can be tailored by vendors to suit their project’s needs and exported in machine learning-ready DICOM + JSON formats.

By partnering with Gradient Health, innovators can use these extensive, diverse datasets to train and validate their AI algorithms, mitigating bias in medical AI and advancing the development of precise, high-quality medical solutions.

Gaining access to top-tier data at the outset of the development process promises long-term benefits. Here’s how:

  • Expand Market Presence: Access the latest cross-vendor datasets to develop medical innovations, expanding your market share.
  • Global Expansion: Enter new regions swiftly with locally sourced data from your target markets, accelerating your global reach.
  • Competitive Edge: Obtain on-demand training data for imaging modalities and disease areas, facilitating product portfolio expansion.
  • Speed to Market: Quickly acquire data for product training and validation, reducing sourcing time and expediting regulatory clearances for faster patient delivery.

“After looking for a data provider for many weeks, I was not able to get even a sample delivery within one month. I was immensely glad to work with Gradient and go from first contact to final delivery within one week!” said Julien Schmidt, chief operations officer and co-founder at Mango Medical.

The Outlook

In recent years, medical AI has experienced significant growth. Innovations in medical imaging in particular have played a pivotal role in enabling healthcare professionals to identify diseases earlier and more accurately in patients with a range of conditions. 

Gradient Health offers a data-compliant, intuitive platform for AI developers, facilitating access to the essential data required to train these critical technologies. This approach holds the potential to save time, resources, and, most importantly, lives. 

More information about Gradient Health is available on the company’s website. They will also be exhibiting at RSNA 2023 in booth #5149 in the South Hall.

Unpacking the Biden Administration’s New AI Order

Posted on by Brian Casey

It seems like watershed moments in AI are happening on a weekly basis now. This time, the big news is the Biden Administration’s sweeping executive order that directs federal regulation of AI across multiple industries – including healthcare. 

The order comes as AI is becoming a clinical reality for many applications. 

  • The number of AI algorithms cleared by the FDA has been surging, and clinicians – particularly radiologists – are getting access to new tools on an almost daily basis.

But AI’s rapid growth – and in particular the rise of generative AI technologies like ChatGPT – have raised questions about its future impact on patient care and whether the FDA’s existing regulatory structure is suitable for such a new technology. 

The executive order appears to be an effort to get ahead of these trends. When it comes to healthcare, its major elements are summarized in a succinct analysis of the plan by Health Law Advisor. In short, the order: 

  • Calls on HHS to work with the VA and Department of Defense to create an HHS task force on AI within 90 days
  • Requires the task force to develop a strategic plan within a year that could include regulatory action regarding the deployment and use of AI for applications such as healthcare delivery, research, and drug and device safety
  • Orders HHS to develop a strategy within 180 days to determine if AI-enabled technologies in healthcare “maintain appropriate levels of quality” – basically, a review of the FDA’s authorization process
  • Requires HHS to set up an AI safety program within a year, in conjunction with patient safety organizations
  • Tells HHS to develop a strategy for regulating AI in drug development

Most analysts are viewing the executive order as the Biden Administration’s attempt to manage both risk and opportunity. 

  • The risk is that AI developers lose control of the technology, with consequences such as patients potentially harmed by inaccurate AI. The opportunity is for the US to become a leader in AI development by developing a long-term AI strategy. 

The Takeaway

The question is whether an industry that’s as fast-moving as AI – with headlines changing by the week – will lend itself to the sort of centralized long-term planning envisioned in the Biden Administration’s executive order. Time will tell.

Predicting the Future of Radiology AI

Posted on by Brian Casey

Making predictions is a messy business (just ask Geoffrey Hinton). So we’re always appreciative whenever key opinion leaders stick their necks out to offer thoughts on where radiology is headed and the major trends that will shape the specialty’s future. 

Two of radiology’s top thought leaders on AI and imaging informatics – Curtis Langlotz, MD, PhD, and Paul Chang, MD – gaze into the crystal ball in two articles published this week in Radiology as part of the journal’s centennial celebration. 

Langlotz offers 10 predictions on radiology AI’s future, briefly summarized below:

  • Radiology will continue its leadership position when it comes to AI adoption in medicine, as evidenced by its dominance of FDA marketing authorizations
  • Virtual assistants will help radiologists draft reports – and reduce burnout
  • Radiology workstations will become cloud-based cockpits that seamlessly unify image display, reporting, and AI
  • Large language models like ChatGPT will help patients better understand their radiology reports
  • The FDA will reform its regulation of AI to be more flexible and speed AI authorizations (see our article in The Wire below)
  • Large databases like the Medical Imaging and Data Resource Center (MIDRC) will spur data sharing and, in turn, more rapid AI development

Langlotz’s predictions are echoed by Chang’s accompanying article in Radiology in which he predicts the future of imaging informatics in the coming age. Like Langlotz, Chang sees the new array of AI-enabled tools as beneficial agents that will help radiologists manage growing workloads through dashboards, enhanced radiology reports, and workflow automation. 

The Takeaway

This week’s articles are required reading for anyone following the meteoric growth of AI in radiology. Far from Hinton’s dystopian view of a world without radiologists, Langlotz and Chang predict a future in which AI and IT technologies assist radiologists to do their jobs better and with less stress. We know which vision we prefer.

What’s Fueling AI’s Growth

Posted on by Brian Casey

It’s no secret that the rapid growth of AI in radiology is being fueled by venture capital firms eager to see a payoff for early investments in startup AI developers. But are there signs that VCs’ appetite for radiology AI is starting to wane?

Maybe. And maybe not. While one new analysis shows that AI investments slowed in 2023 compared to the year before, another predicts that over the long term, VC investing will spur a boom in AI development that is likely to transform radiology. 

First up is an update by Signify Research to its ongoing analysis of VC funding. The new numbers show that through Q3 2023, the number of medical imaging AI deals has fallen compared to Q3 2022 (24 vs. 40). 

  • Total funding has also fallen for the second straight year, to $501M year-to-date in 2023. That compares to $771M through the third quarter of 2022, and $1.1B through the corresponding quarter of 2021. 

On the other hand, the average deal size has grown to an all-time high of $20.9M, compared to 2022 ($15.4M) and 2021 ($18M). 

  • And one company – Rapid AI – joined the exclusive club of just 14 AI vendors that have raised over $100M with a $75M Series C round in July 2023. 

In a look forward at AI’s future, a new analysis in JACR by researchers from the ACR Data Science Institute (DSI) directly ties VC funding to healthcare AI software development, predicting that every $1B in funding translates into 11 new product approvals, with a six-year lag between funding and approval. 

  • And the authors forecast long-term growth: In 2022 there were 69 FDA-approved products, but by 2035, funding is expected to reach $31B for the year, resulting in the release of a staggering 350 new AI products that year.

Further, the ACR DSI authors see a virtuous cycle developing, as increasing AI adoption spurs more investment that creates more products available to help radiologists with their workloads. 

The Takeaway

The numbers from Signify and ACR DSI don’t match up exactly, but together they paint a picture of a market segment that continues to enjoy massive VC investment. While the precise numbers may fluctuate year to year, investor interest in medical imaging AI will fuel innovation that promises to transform how radiology is practiced in years to come.

Autonomous AI for Medical Imaging is Here. Should We Embrace It?

Posted on by Partner Content

What is autonomous artificial intelligence, and is radiology ready for this new technology? In this paper, we explore one of the most exciting autonomous AI applications, ChestLink from Oxipit. 

What is Autonomous AI? 

Up to now, most interpretive AI solutions have focused on assisting radiologists with analyzing medical images. In this scenario, AI provides suggestions to radiologists and alerts them to suspicious areas, but the final diagnosis is the physician’s responsibility.

Autonomous AI flips the script by having AI run independently of the radiologist, such as by analyzing a large batch of chest X-ray exams for tuberculosis to screen out those certain to be normal. This can significantly reduce the primary care workload, where healthcare providers who offer preventive health checkups may see up to 80% of chest X-rays with no abnormalities. 

Autonomous AI frees the radiologist to focus on cases with suspicious pathology – with the potential of delivering a more accurate diagnosis to patients in real need.

One of the first of this new breed of autonomous AI is ChestLink from Oxipit. The solution received the CE Mark in March 2022, and more than a year later it is still the only AI application capable of autonomous performance. 

How ChestLink Works

ChestLink produces final chest X-ray reports on healthy patients with no involvement from human radiologists. The application only reports autonomously on chest X-ray studies where it is highly confident that the image does not include abnormalities. These studies are automatically removed from the reporting workflow. 

ChestLink enables radiologists to report on studies most likely to have abnormalities. In current clinical deployments, ChestLink automates 10-30% of all chest X-ray workflow. The exact percentage depends on the type of medical institution, with primary care facilities having the most potential for automation.

ChestLink Clinical Validation

ChestLink was trained on a dataset with over 500k images. In clinical validation studies, ChestLink consistently performed at 99%+ sensitivity.

A recent study published in Radiology highlighted the sensitivity of the application.

“The most surprising finding was just how sensitive this AI tool was for all kinds of chest disease. In fact, we could not find a single chest X-ray in our database where the algorithm made a major mistake. Furthermore, the AI tool had a sensitivity overall better than the clinical board-certified radiologists,” said study co-author Louis Lind Plesner, MD, from the Department of Radiology at the Herlev and Gentofte Hospital in Copenhagen, Denmark.

In this study ChestLink autonomously reported on 28% of all normal studies.

In another study at the Oulu University Hospital in Finland, researchers concluded that AI could reliably remove 36.4% of normal chest X-rays from the reporting workflow with a minimal number of false negatives, leading to effectively no compromise on patient safety. 

Safe Path to AI Autonomy

Oxipit ChestLink is currently used in healthcare facilities in the Netherlands, Finland, Lithuania, and other European countries, and is in the trial phase for deployment in one of the leading hospitals in England.

ChestLink follows a three-stage framework for clinical deployment.

  • Retrospective analysis. ChestLink analyzes a couple of years worth (100k+) of historic chest x-ray studies at the medical institution. In this analysis the product is validated on real-world data. It also realistically estimates what fraction of reporting scope can be automated.
  • Semi-autonomous operations. The application moves into prospective settings, analyzing images in near-real time. ChestLink produces preliminary reports for healthy patients, which may then be approved by a certified clinician.
  • Autonomous operations. The application autonomously reports on high-confidence healthy patient studies. The application performance is monitored in real-time with analytical tools.

Are We There Yet?

ChestLink aims to address the shortage of clinical radiologists worldwide, which has led to a substantial decline in care quality.

In the UK, the NHS currently faces a massive 33% shortfall in its radiology workforce. Nearly 71% of clinical directors of UK radiology departments feel that they do not have a sufficient number of radiologists to deliver safe and effective patient care.

ChestLink offers a safe pathway into autonomous operations by automating a significant and somewhat mundane portion of radiologist workflow without any negative effects for patient care. 

So should we embrace autonomous AI? The real question should be, can we afford not to? 

More Work Ahead for Chest X-Ray AI?

Posted on by Brian Casey

In another blow to radiology AI, the UK’s national technology assessment agency issued an equivocal report on AI for chest X-ray, stating that more research is needed before the technology can enter routine clinical use.

The report came from the National Institute for Health and Care Excellence (NICE), which assesses new health technologies that have the potential to address unmet NHS needs. 

The NHS sees AI as a potential solution to its challenge of meeting rising demand for imaging services, a dynamic that’s leading to long wait times for exams. 

But at least some corners of the UK health establishment have concerns about whether AI for chest X-ray is ready for prime time. 

  • The NICE report states that – despite the unmet need for quicker chest X-ray reporting – there is insufficient evidence to support the technology, and as such it’s not possible to assess its clinical and cost benefits. And it said there is “no evidence” on the accuracy of AI-assisted clinician review compared to clinicians working alone.

As such, the use of AI for chest X-ray in the NHS should be limited to research, with the following additional recommendations …

  • Centers already using AI software to review chest X-rays may continue to do so, but only as part of an evaluation framework and alongside clinician review
  • Purchase of chest X-ray AI software should be made through corporate, research, or non-core NHS funding
  • More research is needed on AI’s impact on a number of outcomes, such as CT referrals, healthcare costs and resource use, review and reporting time, and diagnostic accuracy when used alongside clinician review

The NICE report listed 14 commercially available chest X-ray algorithms that need more research, and it recommended prospective studies to address gaps in evidence. AI developers will be responsible for performing these studies.

The Takeaway

Taken with last week’s disappointing news on AI for radiology, the NICE report is a wakeup call for what had been one of the most promising clinical use cases for AI. The NHS had been seen as a leader in spearheading clinical adoption of AI; for chest X-ray, clinicians in the UK may have to wait just a bit longer.

Predicting AI Performance

Posted on by Brian Casey

How can you predict whether an AI algorithm will fall short for a particular clinical use case such as detecting cancer? Researchers in Radiology took a crack at this conundrum by developing what they call an “uncertainty quantification” metric to predict when an AI algorithm might be less accurate. 

AI is rapidly moving into wider clinical use, with a number of exciting studies published in just the last few months showing how AI can help radiologists interpret screening mammograms or direct which women should get supplemental breast MRI. 

But AI isn’t infallible. And unlike a human radiologist who might be less confident in a particular diagnosis, an AI algorithm doesn’t have a built-in hedging mechanism.

So researchers from Denmark and the Netherlands decided to build one. They took publicly available AI algorithms and tweaked their code so they produced “uncertainty quantification” scores with their predictions. 

They then tested how well the scores predicted AI performance in a dataset of 13k images for three common tasks covering some of the deadliest types of cancer:

1) detecting pancreatic ductal adenocarcinoma on CT
2) detecting clinically significant prostate cancer on MRI
3) predicting pulmonary nodule malignancy on low-dose CT 

Researchers classified the highest 80% of the AI predictions as “certain,” and the remaining 20% as “uncertain,” and compared AI’s accuracy in both groups, finding … 

  • AI led to significant accuracy improvements in the “certain” group for pancreatic cancer (80% vs. 59%), prostate cancer (90% vs. 63%), and pulmonary nodule malignancy prediction (80% vs. 51%)
  • AI accuracy was comparable to clinicians when its predictions were “certain” (80% vs. 78%, P=0.07), but much worse when “uncertain” (50% vs. 68%, P<0.001)
  • Using AI to triage “uncertain” cases produced overall accuracy improvements for pancreatic and prostate cancer (+5%) and lung nodule malignancy prediction (+6%) compared to a no-triage scenario

How would uncertainty quantification be used in clinical practice? It could play a triage role, deprioritizing radiologist review of easier cases while helping them focus on more challenging studies. It’s a concept similar to the MASAI study of mammography AI.

The Takeaway

Like MASAI, the new findings present exciting new possibilities for AI implementation. They also present a framework within which AI can be implemented more safely by alerting clinicians to cases in which AI’s analysis might fall short – and enabling humans to step in and pick up the slack.  

Can AI Direct Breast MRI?

Posted on by Brian Casey

A deep learning algorithm trained to analyze mammography images did a better job than traditional risk models in predicting breast cancer risk. The study shows the AI model could direct the use of supplemental screening breast MRI for women who need it most. 

Breast MRI has emerged (along with ultrasound) as one of the most effective imaging modalities to supplement conventional X-ray-based mammography. Breast MRI performs well regardless of breast tissue density, and can even be used for screening younger high-risk women for whom radiation is a concern. 

But there are also disadvantages to breast MRI. It’s expensive and time-consuming, and clinicians aren’t always sure which women should get it. As a result, breast MRI is used too often in women at average risk and not often enough in those at high risk. 

In the current study in Radiology, researchers from MGH compared the Mirai deep learning algorithm to conventional risk-prediction models. Mirai was developed at MIT to predict five-year breast cancer risk, and the first papers on the model emerged in 2019; previous studies have already demonstrated the algorithm’s prowess for risk prediction. 

Mirai was used to analyze mammograms and develop risk scores for 2.2k women who also received 4.2k screening breast MRI exams from 2017-2020 at four facilities. Researchers then compared the performance of the algorithm to traditional risk tools like Tyrer-Cuzick and NCI’s Breast Cancer Risk Assessment (BCRAT), finding that … 

  • In women Mirai identified as high risk, the cancer detection rate per 1k on breast MRI was far higher compared to those classified as high risk by Tyrer-Cuzick and BCRAT (20.6 vs. 6.0 & 6.8)
  • Mirai had a higher PPV for predicting abnormal findings on breast MRI screening (14.6% vs. 5.0% & 5.5%)
  • Mirai scored higher in PPV of biopsies recommended (32.4% vs. 12.7% & 11.1%) and PPV for biopsies performed (36.4% vs. 13.5% & 12.5%)

The Takeaway
Breast imaging has become one of the AI use cases with the most potential, based on recent studies like PERFORMS and MASAI, and the new study shows Mirai could be useful in directing women to breast MRI screening. Like the previous studies, the current research is pointing to a near-term future in which AI and deep learning can make breast screening more accurate and cost-effective than it’s ever been before. 

How Vendors Sell AI

Posted on by Brian Casey

Better patient care is the main selling point used by AI vendors when marketing neuroimaging algorithms, followed closely by time savings. Farther down the list of benefits are lower costs and increased revenue for providers. 

So says a new analysis in JACR that takes a close look at how FDA-cleared neuroimaging AI algorithms are marketed by vendors. It also includes several warning signs for both AI developers and clinicians.

AI is the most exciting technology to arrive in healthcare in decades, but questions percolate on whether AI developers are overhyping the technology. In the new analysis, researchers focused on marketing claims made for 59 AI neuroimaging algorithms cleared by the FDA from 2008 to 2022. Researchers analyzed FDA summaries and vendor websites, finding:

  • For 69% of algorithms, vendors highlighted an improvement in quality of patient care, while time savings for clinicians were touted for 44%. Only 16% of algorithms were promoted as lowering costs, while just 11% were positioned as increasing revenue
  • 50% of cleared neuroimaging algorithms were related to detection or quantification of stroke; of these, 41% were for intracranial hemorrhage, 31% for stroke brain perfusion, and 24% for detection of large vessel occlusion 
  • 41% of the algorithms were intended for use with non-contrast CT scans, 36% with MRI, 15% with CT perfusion, 14% with CT angiography, and the rest with MR perfusion and PET
  • 90% of the algorithms studied were cleared in the last five years, and 42% since last year

The researchers further noted two caveats in AI marketing: 

  • There is a lack of publicly available data to support vendor claims about the value of their algorithms. Better transparency is needed to create trust and clinician engagement.
  • The single-use-case nature of many AI algorithms raises questions about their economic viability. Many different algorithms would have to be implemented at a facility to ensure “a reasonable breadth of triage” for critical findings, and the financial burden of such integration is unclear.

The Takeaway

The new study offers intriguing insights into how AI algorithms are marketed by vendors, and how these efforts could be perceived by clinicians. The researchers note that financial pressure on AI developers may cause them to make “unintentional exaggerated claims” to recoup the cost of development; it is incumbent upon vendors to scrutinize their marketing activities to avoid overhyping AI technology.

Get every issue of The Imaging Wire, delivered right to your inbox.

You might also like..

Select All

You're signed up!

It's great to have you as a reader. Check your inbox for a welcome email.

-- The Imaging Wire team

You're all set!