Regulatory attorney Bradley Merrill Thompson, in an analysis of the FDA’s recently released figures on its Breakthrough Device program.

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Artificial Intelligence

AI Speeds Up MRI Scans

In our last issue, we reported on a new study underscoring the positive return on investment when deploying radiology AI at the hospital level. This week, we’re bringing you additional research that confirms AI’s economic value, this time when used to speed up MRI data reconstruction. 

While AI for medical image analysis has garnered the lion’s share of attention, AI algorithms are also being developed for behind-the-scenes applications like facilitating staff workflow or reconstructing image data. 

• For example, software developers have created solutions that enable scans to be acquired faster and with less input data (such as radiation dose) and then upscaled to resemble full-resolution images. 

In the new study in European Journal of Radiology, researchers from Finland focused on whether accelerated data reconstruction could help their hospital avoid the need to buy a new MRI scanner. 

• Six MRI scanners currently serve their hospital, but the radiology department will be losing access to one of them by the end of the year, leaving them with five. 

They calculated that a 20% increase in capacity per remaining scanner could help them achieve the same MRI throughput at a lower cost; to test that hypothesis they evaluated Siemens Healthineers’ Deep Resolve Boost algorithm. 

• Deep Resolve Boost uses raw-data-to-image deep learning reconstruction to denoise images and enable rapid acceleration of scan times; a total knee MRI exam can be performed in just two minutes. 

Deep Resolve Boost was applied to 3T MRI scans of 78 patients acquired in fall of 2023, with the researchers finding that deep learning reconstruction… 

• Reduced annual exam costs by 399k euros compared to acquiring a new scanner
• Enabled an overall increase in scanner capacity of 20-32%
• Had an acquisition cost 10% of the price of a new MRI scanner, leading to a cost reduction of 19 euros per scan
• Was a lower-cost option than operating five scanners and adding a Saturday shift

The Takeaway

As with last week’s study, the new research demonstrates that AI’s real value comes from helping radiologists work more efficiently and do more with less, rather than from direct reimbursement for AI use. It’s the same argument that was made to promote the adoption of PACS some 30 years ago – and we all know how that turned out.

Data Sourcing for Medical AI

Join Gleamer and its partner Gradient Health for a webinar on data sourcing for medical AI at 10 am ET on April 3. Learn from Remi Quilliet of Gleamer and Rod Greco of Gradient how they worked together to speed up AI development.

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The Wire

• Decline in Breakthrough Devices: The number of medical devices designated by the FDA as “breakthrough” fell by 13% in 2023 (145 vs. 166), and is down 30% compared to 2021 (206). A total of 933 Breakthrough Device designations have been awarded since the program began in 2015; of these 21% have been cardiovascular devices while radiology only contributed 3.4%. Breakthrough devices in radiology and/or radiation oncology that have gone on to receive marketing authorization as of December 31, 2023 have included products from Annalise, Reflexion Medical, Ultromics, Koios Medical, and Insightec. 

• Radiology’s Gender Gap Persists: The percentage of women in radiology continues to lag. A new literature review in Clinical Imaging surveyed 22 research studies, finding low female representation in US and Canadian diagnostic radiology residency programs as of 2019 (27% and 32%). Breast imaging was the only subspecialty where women outnumbered men (69%), while female representation was lowest in interventional radiology (11%). Fortunately, the article offers suggestions for boosting female representation, such as mentoring, more preclinical exposure to radiology, and information to counter misperceptions about AI.  

• FDA Clears Siemens’ Self-Driving C-Arm: The FDA has cleared Ciartic Move, a mobile C-arm from Siemens Healthineers for intraoperative surgical imaging. The C-arm includes a self-driving feature to move it into previously stored positions with the push of a button, while its omnidirectional wheels enable more precise movements even in small spaces. Combined with a remote control, Ciartic Move should reduce the burden of device positioning on surgical staff and radiologic technologists, with Siemens estimating a 50% time savings in intraoperative imaging during surgical procedures. 

• Getting Men to AAA Screening: What’s the best way to get more men to attend ultrasound screening for abdominal aortic aneurysm? In a study in JVS-Vascular Insights, researchers reached out to 259 men who didn’t respond to AAA screening invitations and compared them to those who did. Non-attenders were more likely to live alone (41% vs. 22%), smoke (27% vs. 14%), and receive home nursing (10% vs. 0.5%), and were less likely to be highly educated (54% vs. 71%). Given that smoking is a risk factor for AAA, targeting these individuals should be a priority. 

• Blackford Adds Radiobotics to Platform: Blackford has added additional capabilities for AI analysis of musculoskeletal images to its Blackford Platform through a relationship with Radiobotics, which will make its RBfracture and RBknee algorithms available. RBfracture detects fractures on X-ray in seconds, and can also detect joint effusions as well as lipohemarthrosis, a more subtle indication of fracture. RBknee is an automated algorithm for analyzing knee X-rays for osteoarthritis. Other recent Blackford Platform additions include Pixyl, Imbio, Avicenna, Bot Image, See-Mode, and Rayscape.  

• PET/MRI Changes Breast Cancer Treatment: Using PET/MRI in women with early-stage breast cancer changed management in 28% of patients. In a study presented at the European Breast Cancer Conference, Italian researchers used PET/MRI in 205 patients scheduled for breast-conserving surgery to look for cancer metastasis. Of the 57 patients whose treatment changed, 18 got chemotherapy while the rest got different surgical approaches. Wider use of PET/MRI for this application will likely be hindered by the high cost and limited distribution of scanners, however.

• CT Lung Screening’s Mixed News: A new study on CT lung cancer screening in JAMA Network Open has good news and bad news. The good news is that USPSTF’s 2021 screening criteria expansion brought 619k newly eligible people in for screening in 2022; the bad news is that US lung screening uptake was 16% in 2022, much lower than other population-based screening tests. The criteria expansion brought in more women and people of color, but more outreach is needed to make screening more accessible. 

• Medality Launches CME Tracking Portal: Online medical education firm Medality has launched Admin Portal, an online tool designed to help radiology practices track their staff’s education and training activities. Admin Portal provides dashboards that help users track radiologist training outcomes and performance, while also supporting personalized learning plans with assigned courses. Medality sees better online training as a means to give radiologists sub-specialized skills that can help practices manage workforce shortages. 

• inHEART 3D AI Clearance: inHEART announced the FDA 510(k) clearance and US launch of its AI software module, which automates the segmentation of preprocedural CT and MR images to create 3D cardiac models used to guide ablation procedures. inHEART-guided ablations could have a major impact if they match early clinical evaluations, which showed that inHEART cut VT procedure times by 60% (from 5hrs to <2hrs) and reduced VT recurrence rates by 38%. The solution already had European CE Mark approval.

• ASRT Promotes RT Awareness: The ASRT has launched a new campaign called “Be Seen” to promote public awareness of the role that radiologic technologists play in healthcare. The campaign features ads with Michael Benzaia, a professional actor who has also worked as an X-ray and CT technologist. The campaign includes social media posts and a website describing the different roles available to RTs … and makes note of the fact that there will be 15.4k job openings for radiographers and MR technologists between now and 2042. 

• Quibim Adds Liver AI to Portfolio: Quibim is adding a tool for AI-based quantification of liver MRI scans to its portfolio. QP-Liver provides automated quantification of tissue fat and iron from MRI scans and correlates them with reference digital pathology data, helping clinicians diagnose diffuse liver diseases. QP-Liver has received regulatory certifications in the UK and EU and joins algorithms Quibim has launched for quantitative analysis of brain MRI scans and prostate MRI analysis. 

• CT Reveals Secrets of Iconic Gen Z Mug: The Stanley Quencher insulated mug has become a Gen Z icon, so imagine the horror when social media influencers discovered they contained lead. Enter industrial imaging firm Lumafield, which ran a Quencher through its Neptune industrial CT scanner to analyze its material composition. Neptune discovered the presence of lead solder used to make the massive mugs, but confirmed that the solder is isolated in a sealed area that doesn’t come in contact with consumers. Still unexplained is why young people have to carry around so much water.

Go Virtual with Ease

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An Easier Way to Manage Training and CME

Medality’s new Admin Portal offers radiology practices a single location to manage radiologist training development needs and CME requirements. Request a demo today.

Echo AI and Mobile Health

Powered by AI-automated software, mobile ultrasound devices are taking echo exams out of the conventional clinical setting and on the road. In this article, learn how Singapore is using Us2.ai’s echo AI software to complete the full mobile exam pathway whilst maintaining high clinical standards.

The Resource Wire

• The Clinical Value of Soft-Tissue Chest X-Ray: Soft-tissue techniques can improve the visibility and accuracy of chest X-ray.  Learn about two important soft-tissue methods – bone suppression and dual-energy subtraction – in this white paper from Riverain Technologies.

• A Step-by-Step Approach to Radiology AI Adoption: Widespread adoption of radiology AI has the potential to revolutionize patient care, but the path to success requires a systematic approach. Blackford offers a step-by-step guide for healthcare providers looking to get started. 

• 8 Ways to Monetize Your Imaging Data: Data monetization can help radiology practices gain value from the vast amount of data they generate. But it takes careful planning to ensure data privacy and security. Learn how to do it in this guide from Enlitic. 

• 3 Good Reasons to Add Mammography: There are three good reasons to add mammography services at your imaging site as providers expect higher demand for breast imaging services. Get the facts about mammography on this resource page from Siemens Healthineers. 

• Achieve the Benefits of AI with Choice and Control: AI for imaging is here. More and more applications are clearing regulatory hurdles and proving to be mature enough to support clinical use cases. Learn how to achieve the benefits of AI on your own terms in this guide from Merge by Merative. 

• An Integrated Healthcare Network Uses PocketHealth in Parallel with Legacy Image Exchange: Valley View Hospital in Colorado wanted to share images and records with patients while continuing to use its legacy image exchange for providers. Find out how PocketHealth helped them do it in this article. 

• Faster MRI Scans with No Compromise: What if you could speed up your MRI scans with no compromise on image quality? In this video from RSNA 2023, we talked to SpinTech MRI CEO Karen Holzberger and Senior Clinical Sales Executive John Ciliberto about how their STAGE software is making this vision a reality.

• AI Applications in Neuroradiology: What are the most common AI applications in neuroradiology? This downloadable e-book from Bayer and Calantic Digital Solutions reviews the most common AI applications for brain imaging and the evidence behind them.  

• Get to Know DeepHealth: DeepHealth offers a portfolio of AI solutions for clinical applications ranging from lung to prostate to brain indications. Learn more about DeepHealth and its AI-driven breakthroughs in care delivery.

• Best in KLAS PACS: Intelerad’s InSight PACS has been named Best in KLAS for UK and Ireland PACS by KLAS Research. Learn more about the solution that’s been adopted by over 250 healthcare providers across the UK and Ireland. 

• United Imaging’s RSNA 2023 Highlights: What were the highlights in United Imaging’s booth at RSNA 2023? Watch this video interview with CEO Jeffrey Bundy, PhD, at the conference to learn about the company’s 510(k)-pending 5T MRI scanner, mobile digital radiography system, and more. 

• An Update on CARPL from HIMSS 2024: What’s the latest news from AI platform company CARPL.ai? Check out this video from HIMSS 2024 to discover how CARPL is making it easier than ever to deploy and use radiology AI. 

• Artificial Intelligence for Coordinated Care: TeraRecon’s Eureka AI platform is a vendor-agnostic hosting platform that can help execute clinical and non-clinical AI algorithms to improve outcomes, reduce burnout, and streamline radiology workflow. Learn how it works on this page.

• Solutions to Transform Medical Image Delivery: Medical providers and health systems are looking to ditch the disc and modernize their patients’ journey. Learn how Clearpath helps them reduce the cost of retrieving and fulfilling patient requests for imaging and medical records.