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Lunit’s Deal for Volpara | AI Transparency Rules December 18, 2023
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Together with
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“The AI industry in imaging is realising that regulatory approval and getting a product to market is just the start, not a guarantee of success. Fun times ahead!”
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Steve Holloway, managing director of Signify Research, on Lunit’s bid to acquire Volpara Health.
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Welcome to the last Imaging Wire of the year, as we’ll be taking a break for the holidays! Thank you to all of our readers and sponsors who make this newsletter possible, and keep an eye out for our next issue on January 4.
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Is the long-awaited consolidation of the healthcare AI sector gaining steam? In a deal valued at close to $200M, South Korean AI developer Lunit announced a bid to acquire Volpara Health, a developer of software for calculating breast density and cancer risk.
At first glance, the alliance seems to be a match made in heaven. Lunit is a well-regarded AI developer that has seen impressive results in clinical trials of its Insight family of algorithms for indications ranging from mammography to chest imaging.
- Most recently, Lunit received FDA clearance for its Insight DBT software, marking its entry into the US breast screening market, and it also raised $150M in a public stock offering.
Volpara has a long pedigree as a developer of breast imaging software, although it has shied away from image analysis applications to instead focus on breast center operations and risk assessment, in particular by calculating breast density.
- Thus, combining Lunit’s concentration in image analysis with Volpara’s focus on operations and risk assessment enables the combined company to offer a wider breadth of products to breast centers.
Lunit will also be able to take advantage of the marketing and sales structure that Volpara has built in the US mammography sector (97% of Volpara’s sales come from the US, where it has an installed base of 2k sites). Volpara expects 2024 sales of $30M and is cash-flow positive.
The question is whether the acquisition is a sign of things to come in the AI market.
- As commercial AI sales have been slow to develop, AI firms have largely funded their operations through venture capital firms – which are notoriously impatient in their quest for returns.
In fact, observers at the recent RSNA 2023 meeting noted that there were very few new start-up entrants into the AI space, and many AI vendors had smaller booths.
- And previous research has documented a slowdown in VC funding for AI developers that is prompting start-up firms to seek partners to provide more comprehensive offerings while also focusing on developing a road to profitability.
The Takeaway
It’s not clear yet whether the Lunit/Volpara deal is a one-off combination or the start of a renewed consolidation trend in healthcare AI. Regardless of what happens, this alliance unites two of the stronger players in the field and has exciting potential for the years to come.
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A Panel on Patient-Centricity and Breaking Down Barriers to the Quadruple Aim
Watch this panel hosted by PocketHealth at RSNA featuring industry leaders discussing the advantages of a patient-centric approach to image exchange and its positive impact on quadruple aim goals, including population health, patient experience, avoiding revenue loss, and increasing staff wellness.
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Discover How to Unlock Dual-Source CT
Discover how dual-source CT technology from Siemens Healthineers delivers the temporal resolution and scan speed needed to reduce motion artifacts, and how the company is making dual-source CT available to a wider range of hospitals and imaging centers.
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- HHS Posts AI Transparency Rule: AI transparency is once again in the headlines with HHS’ publication of a final rule that among other issues sets transparency requirements for predictive AI algorithms used in healthcare. The rule aims to make it possible for clinicians to access a consistent, baseline set of information about AI algorithms (along the lines of ACR’s new checkmark system for AI transparency). The final rule also includes provisions on data interoperability and information blocking requirements.
- Growth of US Health Spending Eases: Is the US getting a handle on healthcare spending? In new CMS data, US national health expenditures grew 4.1% in 2022 to $4.5T. That’s a lot of money, but it’s down slightly compared to the 4.4% growth rate from 2016-2019 (growth rates fluctuated greatly in 2020 and 2021 due to the COVID-19 pandemic). What’s more, healthcare’s share of US GDP actually fell in 2022 versus 2021 (17.3% vs. 18.2%). But health spending is expected to grow 5.4% annually from 2022-2031.
- RadTech Student Enrollment Grows 9%: Enrollment at ARRT-approved radiologic technologist radiography training programs grew 9% in 2023, to 17.7k students compared to 16.2k in 2022. The ASRT’s annual survey found that enrollment was also up at radiation therapy (+8%) and nuclear medicine programs (+8%), but fell in sonography (-11%) and MRI (-23%). As radiography makes up a large majority of RTs in training, the growth in that sector could be a sign that there’s an end in sight to the field’s persistent workforce shortage.
- AI Predicts Breast MRI Artifacts: In European Radiology, German researchers describe how they used an AI algorithm to predict artifacts before contrast administration in breast MRI exams. The convolutional neural network was tested in 2.8k contrast-enhanced breast MRI studies and detected 31% of artifacts before contrast was administered, with AUC of 0.66 and specificity of 89%. If refined and applied clinically, the algorithm could enable breast MRI sites to take action to prevent artifacts before scans even begin.
- Personal Care Products Prompt MRI Artifacts: On the subject of MRI artifacts, researchers from Saudi Arabia found they can be caused by personal care products like cosmetics and shampoo. In Journal of Radiation Research and Applied Sciences, researchers performed phantom tests with a 1.5T MRI scanner on 22 popular personal care products. Sixteen of the products produced artifacts ranging from mild to severe, and some artifacts could even be confused with pathology. Many consumer products contain magnetic substances like iron dioxide and titanium dioxide that can produce artifacts; researchers recommend screening patients for such products before scans.
- MRI Shows Exercise’s Benefits in Alzheimer’s: Two research studies released last week used brain MRI scans to show the benefits of physical exercise in improving brain health in older people, and possibly staving off the onset of Alzheimer’s disease. In Neuroimage, Swiss researchers found that older adults who exercised more had less decline in thickness of their entorhinal cortex. And in Journal of Alzheimer’s Disease, researchers found that among 10.1k people scanned at Prenuvo wellness centers, those who reported more physical activity had greater brain volumes on MRI.
- ChatGPT Dominates Radiology’s Top 10: Research papers about ChatGPT dominated a list of most-cited articles for 2023 in Radiology. Articles about the generative AI algorithm occupied the top four spots on the list, while general articles on AI and deep learning took three more positions. Radiology’s list of most-downloaded articles was more varied, with a study on myocardial PET tracer uptake after COVID vaccination occupying the top position and COVID-related studies taking up three other spots; AI-related papers took three positions.
- Sectra Sales Boom: Sectra saw revenues boom in the company’s second fiscal quarter (end-October) as it expands its footprint in the US and successfully transitions to offering its software under a SaaS model. The company hit a quarterly record for revenues after currency adjustment (+40% to $77M) and operating profit (+64% to $17M). Sectra recently landed a large contract in Scotland and was highlighted in a recent KLAS report as the company most often selected for PACS network installations.
- AI Aids TB Screening in India: Using Qure.ai’s algorithm as part of a tuberculosis screening program in India led to a 16% increase in TB detection. In PLOS Digital Health, researchers described their use of Qure’s qXR algorithm to help with chest X-ray screening of 8.3k patients already suspicious for TB based on clinical history; 213 had confirmed disease. In all, 16% of cases positive for TB were identified by AI alone and not radiologists. The findings show AI can help with disease screening in resource-challenged countries.
- FDA Clears Chest X-Ray AI: UK-based medical AI developer Bering has received FDA 510(k) clearance for BraveCX, an algorithm for triaging chest X-ray. The software analyzes radiographs for suspected clinical findings like pleural effusion and pneumothorax and alerts physicians to cases with suspicious findings. Bering plans to offer BraveCX either as a cloud-based service, direct on-premises, or integrated with X-ray devices.
- AI for Fracture Detection in ER: Emergency radiologists in Germany reported high satisfaction with AI for fracture detection in the ER after a trial study with Gleamer’s BoneView algorithm for X-rays. In Investigative Radiology, researchers surveyed 47 clinicians (34 radiologists, 13 traumatologists) on their impressions after AI implementation, finding that they believed AI helped them reduce missed findings and made them “safer” clinicians (but not necessarily “faster”). Radiologists used AI more than traumatologists and rated its benefits higher.
- Laza Medical Series A: Interventional imaging startup Laza Medical closed its $36M Series A financing round that it will use to accelerate product development and further expand its team. The company is developing a robotically controlled AI-powered ultrasound system that would allow cath lab teams to avoid fluoroscopy guidance during EP and structural heart procedures. Laza Medical launches with solid relationships — it came out of the Shifamed innovation hub (also home of Supira Medical and Akura Medical) and GE HealthCare was among its Series A investors.
- Intravascular Imaging’s PCI Advantage: A new meta-analysis found that intravascular imaging-guided PCI brings better outcomes than the current standard, angiography. In the study of 32 randomized controlled trials and 22,684 patients, intravascular imaging-guided PCI was associated with significantly reduced risks for MACE (-28%, the primary endpoint), as well as CV death (-44%), stent thrombosis (-52%), and target lesion revascularization (-25%) compared to angiography. Functionally guided PCI (e.g., FFR and iFR), also outperformed angiography, with a 19% reduced risk for MACE.
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New Industry Research on Cloud in Imaging
77% of imaging organizations rely on cloud – but most still haven’t fully integrated cloud or maximized its potential. Check out the new industry research report from Merge by Merative on enterprise cloud adoption and its challenges.
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Hot Topics from RSNA 2023
What were some of the hot topics at RSNA 2023? In this edition of The Imaging Wire Show, we caught up with Dave Wilson, vice president of marketing and communications at Enlitic, to discuss major trends at the meeting and new technologies the company was highlighting.
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Major Milestones in Platform AI
It’s been a busy year for AI platform developer Blackford. We reviewed the company’s major milestones in this video interview from RSNA 2023, in which we talked to Blackford executives David Hilderbrand and Anthony Cammack.
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- Top 5 Trends from RSNA 2023: What were the top 5 trends from RSNA 2023? Check out this review from Brad Levin of Visage Imaging on the topics and technologies that took center stage in Chicago.
- What Can We Do About Physician Burnout? Clinical burnout is widespread in healthcare. What can be done to combat burnout in imaging? Listen to Sonia Gupta, MD, of Change Healthcare as she addresses the concerns and offers possible solutions that you can use right now.
- The Intersection of Health Technology and Business: How are the worlds of health technology and business intersecting? In this episode of The Radiology Report, Intelerad Medical Systems President Morris Panner sits down with Medality CEO Daniel Arnold to explore his career and discuss the evolution of the industry.
- A Better Way to Deploy AI: CARPL.ai’s end-to-end modular platform for AI deployment is changing how University Hospitals in Cleveland uses AI to enhance patient care. Hear from UH clinicians and administrators as they share their experiences.
- How to Revamp Patient Engagement: What’s the best way to eliminate patient frustration and get them engaged with healthcare again? Find out how technology can revamp the patient engagement experience in this article produced in collaboration with Nuance in Becker’s Hospital Review.
- Circulation on the Run: Looking for a weekly summary of hot cardiovascular topics in the journal Circulation? Check out Circulation on the Run, a podcast series featuring Carolyn Lam, MD, of echo AI developer Us2.ai.
- Starting a CT Lung Cancer Screening Program: There’s no doubt CT lung cancer screening reduces lung cancer mortality. In this Imaging Wire Show, we discuss how to set up CT lung screening and the technologies available to help with Chip Gilkeson, MD, of University Hospitals Cleveland Medical Center and Steve Worrell of Riverain Technologies.
- Improving the Patient Experience: How is Clearpath improving the healthcare experience for patients? Learn more about the company and its solutions for ditching the disc when sharing images and records with patients.
- AI in Radiology and the Considerations for Regulation: AI in healthcare has grown quickly, as have discussions about AI regulation. Listen to this on-demand webinar from Bayer and Calantic Digital Solutions to hear expert perspectives on the current and future state of AI governance in healthcare and radiology.
- Clinical Decision-Making with CEM: Learn more about contrast-enhanced mammography (CEM) in this on-demand recording of a GE HealthCare Clinical Conversations webinar featuring Gaelyn Scuderi, MD, in which she discusses impactful cases and the value she sees in CEM.
- Improving Image Acquisition: Watch this video interview from RSNA 2023 with Subtle Medical Founder Greg Zaharchuk, MD, PhD, to learn about the company’s AI-based technology for improving image acquisition, including SubtleMR, SubtlePET, and other applications.
- AI-Based Innovations for Fracture Detection: Gleamer has been honored with the “Santé Future” (Healthcare of the Future) award by the prestigious Décideurs Magazine in France! Learn more about the company and its BoneView solution for fracture detection.
- Clarity, Speed, and Confidence for MRI Efficiency: Radiologists have used a variety of methods to improve efficiency, but many of these methods come with drawbacks. Find out in this article how SpinTech MRI takes on the challenge of MRI efficiency with its STAGE software.
- AMRIC’s Multimodality Approach to Medical Imaging: AMRIC is a new premium imaging clinic on Manhattan’s Upper East Side. Learn about their multimodality approach to medical imaging and why they turned to United Imaging for cutting-edge CT, MRI, and molecular imaging technology.
- A Tactical Approach to Leadership Success: Learn new strategies for achieving leadership success in this on-demand recording of a RadEqual webinar sponsored by Intelerad and the American Association for Women in Radiology, and featuring Geraldine McGinty, MD, and Melissa Davis, MD.
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