Apurv Soni, MD, PhD, of UMass, speaking on post-market monitoring of AI-enabled medical devices at last week’s FDA DHAC meeting.

AI-powered health informatics company DeepHealth was launched one year ago as a subsidiary of imaging services provider RadNet. We got an update on the company and its milestones over the past year in this Imaging Wire Show interview with new CEO Kees Wesdorp.

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Artificial Intelligence

How Should AI Be Monitored?

Once an AI algorithm has been approved and moves into clinical use, how should its performance be monitored? This question was top of mind at last week’s meeting of the FDA’s new Digital Health Advisory Committee.

AI has the potential to radically reshape healthcare and help clinicians manage more patients with fewer staff and other resources. 

• But AI also represents a regulatory challenge because it’s constantly learning, such that after a few years an AI algorithm might be operating much differently from the version first approved by the FDA – especially with generative AI. 

This conundrum was a point of discussion at last week’s DHAC meeting, which was called specifically to focus on regulation of generative AI, and could result in new rules covering all AI algorithms. (An executive summary that outlines the FDA’s thinking is available for download.)

• The stakes are high – FDA Commissioner Robert Califf, MD, opened the meeting expressing concern that AI’s financial impact is taking precedence over its value to patients and clinicians. 

Radiology was well-represented at DHAC, understandable given it has the lion’s share of authorized algorithms (73% of 950 devices at last count). 

• A half-dozen radiology AI experts gave presentations over two days, including Parminder Bhatia of GE HealthCare; Nina Kottler, MD, of Radiology Partners; Pranav Rajpurkar, PhD, of Harvard; and Keith Dreyer, DO, PhD, and Bernardo Bizzo, MD, PhD, both of Mass General Brigham and the ACR’s Data Science Institute.  

Dreyer and Bizzo directly addressed the question of post-market AI surveillance, discussing ongoing efforts to track AI performance, including … 

• The ACR’s launch earlier this year of the ACR Recognized Center for Healthcare-AI (ARCH-AI), a new quality assurance and certification program.
• Assess-AI, an initiative within ARCH-AI launched last week to provide a central data registry to monitor AI algorithm performance in real-world clinical settings.
• The Healthcare AI Challenge, a community for healthcare AI validation and monitoring that’s a collaboration between ACR, MGB, and several other academic institutions. 

The Takeaway

Last week’s DHAC meeting offers a fascinating glimpse at the issues the FDA is wrestling with as it contemplates stronger regulation of generative AI. Fortunately, radiology has blazed a trail in setting up structures like ARCH-AI and Assess-AI to monitor AI performance, and the FDA is likely to follow the specialty’s lead as it develops a regulatory framework.

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Visit Enlitic at RSNA 2024 at booth #4365 to learn how the company is revolutionizing radiology with its data standardization solutions, including data migration technology through its acquisition of Laitek. Book a demo today.

The Wire

• AI and Radiologist Burnout: AI is touted as a solution for radiologist burnout by taking over tedious tasks. But a new study from China in JAMA Network Open raises questions about that idea. Researchers in 2023 surveyed 6.7k radiologists from 1.1k hospitals, finding radiologists using AI were 18% more likely to experience burnout than those who didn’t after variable adjustment, and burnout odds increased with higher AI use, up to 39% for those using AI consistently. But are the results generalizable from China to the U.S.?

• Deciphering the De Novo Pathway: The FDA clearance earlier this year of Darmiyan’s BrainSee AI algorithm for detecting mild cognitive impairment was a milestone for AI in that it used the agency’s de novo authorization pathway. But the de novo path includes special controls requiring manufacturers to perform post-market surveillance that aren’t required for 510(k) clearances, for example. The situation is outlined in a new article in JAMA Neurology highlighting the FDA’s evolving thinking on AI regulation … which may require extra work by AI developers.

• Thyroid Meds Linked to Bone Loss: RSNA 2024 starts on December 1, and new research to be presented in Chicago is already trickling out. In one study, researchers used DEXA scans to show that levothyroxine – a commonly prescribed medication for underactive thyroid – can lead to bone loss. In 81 patients with a median age of 73 followed over 6.3 years, those taking levothyroxine saw greater loss of total-body bone mass and total-body bone density. The findings are concerning due to the prevalence of levothyroxine use.

• MRI Shows Vaping’s Effects: In another RSNA 2024 study, researchers performed MRI scans on 31 healthy smokers and vapers ages 21-49. Participants got scans before and after smoking different types of combustibles. Compared to non-vapers or smokers, study participants had a decline in vascular function and lower venous oxygen saturation, and the decline was greatest for those inhaling e-cigarettes with nicotine, followed by e-cigarettes without nicotine. The findings suggest there’s an immediate decrease in lung oxygen uptake after vaping. 

• Philips Updates Helium-Free MRI: Philips is planning to launch the next generation of its BlueSeal helium-free superconducting MRI technology at RSNA 2024. BlueSeal 1.5T sports a 70cm bore that’s preloaded with 7 liters of helium and never needs refilling. What’s more, the scanner doesn’t need a quench pipe, making siting and installation easier. The scanner also includes a suite of AI-enabled workflow, planning, and image acquisition solutions, ranging from SmartExam for scan planning to SmartReading for automated report generation. 

• Remote Scanning Cleared for Philips: In other Philips news, the company received FDA clearance for features supporting remote scanning and protocol adjustment on its Radiology Operations Command Center. Radiologists can use ROCC to assist radiologic technologists remotely for MRI and CT scans, enabling remote users to edit scanner consoles in real time. Remote scanning could counter the RT shortage by enabling highly trained personnel to guide more complex scans remotely. 

• Exablate Approval on Philips MR: Focused ultrasound developer Insightec received the CE Mark and FDA marketing authorization for use of its Exablate Prime system with Philips MRI scanners. The authorizations cover certain 1.5T and 3T scanners, and will make noninvasive MRI-guided focused ultrasound treatments more widely available for patients with essential tremor and some symptoms of Parkinson’s disease. 

• Paper Describes 11.7T Brain MRI: French researchers have published one of the first peer-reviewed papers describing the operation of a new 11.7T MRI scanner. The Iseult scanner was developed at the French Alternative Energies and Atomic Energy Commission (CEA) and has been called “the world’s most powerful clinical MRI scanner.” The new paper in Nature includes images from the first scans on healthy adults that show brain tissue in exquisite detail. A project to build another 11.7T scanner is moving ahead in the U.K.

• The State of Lung Cancer Screening: A new report from the American Lung Association on lung cancer in the U.S. illustrates some progress being made with CT lung cancer screening, but much work remains. Nationally, 16% of eligible high-risk individuals were screened, from a high of 29% in Rhode Island to a low of 8.6% in Wyoming. While still low compared to other cancer screening exams, the national figure is higher than the single-digit lung screening rates that are often quoted for the U.S. 

• Riverain to Show CAC Scoring at RSNA: Riverain Technologies is planning to enter the coronary artery calcium scoring segment by displaying a CAC solution at RSNA 2024. CAC scores derived from CT scans can indicate risk of future heart disease, and in many cases can be produced from scans ordered for other clinical indications. Riverain plans to add CAC scoring to its ClearRead CT software suite, enabling users to acquire incidental CAC scores from every ungated CT. ClearRead CT CAC is pending FDA clearance. 

• Dual-Energy X-Ray Detects CAC: CT is typically used to detect coronary artery calcium, but a new paper details how KA Imaging’s single-exposure dual-energy X-ray technique performed well relative to CT. In 61 bone marrow transplant patients, researchers found that radiologists reading dual-energy bone images had ROC-AUC for detecting CAC in the range of 0.954-0.973 and valve/vascular calcification of 0.965-0.971, indicating excellent agreement with CT. Single-exposure dual-energy X-ray may overcome some of the artifacts that have hindered dual-exposure CAC detection in the past. 

• Canon Advances Photon-Counting CT: Canon Medical Systems is reporting progress in its effort to develop and commercialize a photon-counting CT scanner. The company is collaborating with Hiroshima University Hospital in Japan in a relationship first announced in 2023, and the partners provided an update last week describing acquisition of the first clinical images. University radiologists say photon-counting CT acquires finely detailed images of the bones and lungs, and believe radiation could be reduced as much as 90% depending on the organ being imaged.  

• Fetal Ultrasound AI Cleared: French software start-up BrightHeart received FDA clearance for its first AI application, for detecting congenital heart defects on fetal ultrasound exams. The company believes its software will help clinicians detect abnormalities that can be signs of CHDs, and help initiate therapeutic interventions. BrightHeart was founded two years ago by two Paris-based fetal cardiologists and emerged from stealth last year. The clearance paves the way for the company to enter the U.S. market. 

• United Gets New Installations: United Imaging has installed new scanners at several sites in the western U.S. The company installed its uMR Omega 3T MRI scanner at X-Ray Associates of New Mexico in Albuquerque, with the installation including the company’s Starlight Experience patient-calming option. It also installed its new uMI Panvivo PET/CT scanner at Pueblo Medical Imaging in Nevada. uMI Panvivo debuted at EANM 2024 and will be highlighted at next week’s RSNA 2024.

• GE Adds Features to OEC C-Arm: GE HealthCare added new features to its OEC 3D mobile cone-beam CT C-arm to support interventional pulmonology procedures like endoscopic bronchoscopy. The additions include OEC 3D Lung Suite for 2D and 3D lung imaging and OEC Open for transferring 3D volumes to navigation and robotic systems.

• Subtle Medical Partners with 626: Subtle Medical has partnered with imaging equipment service provider 626 to provide its SubtleMR solution for MRI acceleration. 626 sees SubtleMR as a solution to help its clients extend the life of their scanners and reduce equipment costs associated with OEM upgrades. 

• TeraRecon Expands Infinitt Europe Alliance: TeraRecon is partnering with Infinitt Europe to integrate its Intuition advanced visualization software into Infinitt Europe’s PACS applications. The companies have had a longstanding relationship in Europe, but the new expansion will make it easier for Infinitt Europe customers to customize TeraRecon tools. 

• Cortechs Lands News Funding: Neuro AI developer Cortechs.ai raised additional funding through a Series C round. The company said the round was oversubscribed but did not release the total value. Cortechs said it would use the funds to roll out new product features, boost its commercial footprint, and fund R&D efforts. 

• Board Certification Is Big Business: Physician board certification is a $12B business in the U.S., with initial board certification costing $2.9B and continuing certification another $9.1B. A new paper in the American Journal of Medicine breaks down the costs, noting that initial certification costs a physician $2.9k while continuous certification costs $263 annually. In 2022, the certification process generated $47M in surplus and $839M in net balance for all ABMS member boards, up 31% from 2014.

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Connecting Patients to Exceptional Care

Mach7 Technologies’ enterprise imaging solutions connect patients and clinicians across the globe to enable exceptional care. As modern healthcare evolves, so should your strategies. Schedule a demo at RSNA 2024 or stop by booth #3953 to learn more.

Book an RSNA Meeting with Riverain

Riverain’s ClearRead technology with Clear Visual Intelligence can improve your ability to detect lung cancer with either CT or X-ray. Book at meeting with them at RSNA 2024 or drop by for a visit at booth #4523.

The Resource Wire

• Book an RSNA Meeting with CARPL: Explore radiology AI like never before by booking a meeting with CARPL at RSNA 2024, or drop by booth #5733 to tune in to any of seven research presentations across the show.

• Discover Prenuvo at RSNA 2024: Discover how Prenuvo is advancing research and redefining the future of healthcare at booth #1239 at RSNA 2024. Learn about their cutting-edge MRI technology first-hand and explore partnership opportunities. 

• AI-Driven Enterprising Imaging: Learn how to unlock the full potential of AI-driven enterprise imaging in this Lunch & Learn session with AGFA HealthCare at 12 pm on December 4 at RSNA 2024. Save your spot and RSVP today!

• TeraRecon Doc Talks at RSNA 2024: Visit the TeraRecon booth #8134 at RSNA 2024 to hear captivating presentations from radiology thought leaders every day of RSNA week. Schedule a meeting today. 

• Connect with United Imaging at RSNA 2024: United Imaging will be celebrating the theme of Building Intelligent Connections at RSNA 2024. Come visit the company at booth #1929 to learn about their imaging solutions and how they connect to United’s mission of Equal Healthcare for All.

• 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.

• Learn about Gleamer at RSNA 2024: Visit Gleamer at booth #5144 at RSNA 2024 to learn about their novel AI solutions for musculoskeletal imaging, including measuring Cobb angles on X-ray and the beneficial impact of BoneView for fracture detection. 

• Meet with Medality at RSNA 2024: Book a visit with Medality at RSNA 2024 or swing by their booth #3140 to see how they are at the forefront of practice growth and training in radiology. 

• Discover the Power of an AI Ecosystem: Get the insights you need to fuel your AI strategy in the Bayer Visionary Theater at RSNA 2024. Preview the theater sessions today and plan to attend at booth #2514 – and don’t forget to experience the Tunnel of Innovation!

• Connect with Intelerad at RSNA 2024: Connect with Intelerad at RSNA 2024 to see how they can empower your radiology team to deliver faster, more accurate diagnostics. Visit them at booth #6113 to see how they’re solving everyday radiology workflow challenges with scalable, cloud-based solutions. 

• Meet Merge at RSNA 2024: Merge is looking forward to sharing a wide range of news, innovations, and updates at RSNA 2024. Join them at booth #6100 to explore how their imaging solutions put your workspaces, clinicians, and transformation into focus. 

• Give Your Patients the Experience They Want: Empower patients to take control of their healthcare journey by giving them mobile access to their records and images with Clearpath, the world’s first digital fulfillment platform for records and films. Book a demo today. 

• Your Trusted Enterprise Imaging Cloud Partner: Visit Optum at RSNA 2024 booth #6750 to learn how their cloud-based enterprise imaging solutions can enhance the potential of your imaging data for efficient, cost-effective care.

• Leading Radiology Forward at RSNA 2024: DeepHealth is leading radiology forward through AI-powered informatics and smart technology. Book a meeting today at RSNA 2024 booth #1340 to learn how they can help you achieve increased staff productivity and a better experience for patients and staff.  

• AI-Driven Novice Heart Failure Screening: We hear a lot about AI’s potential to expand echocardiography to far more users and clinical settings, and a study using Us2.ai’s AI-automated echo analysis and reporting solution showed that echo AI might make novice-led heart failure screening possible.

• Breakthroughs in Healthcare. For Everyone. Join Siemens Healthineers at RSNA 2024 booth #2529 to experience the future of healthcare. Explore cutting-edge innovations, connect with leading experts, and collaborate with industry professionals in live demonstrations. 

• Your In-Workflow Copilot Experience: Microsoft’s PowerScribe Smart Impression harnesses generative AI to automatically generate draft impressions and recommendations, saving you time and reducing workload-related stress. Learn how it can become your in-workflow copilot today. 

The Industry Wire

1. Chronic pain affects 24.3% of U.S. adults.
2. Eli Lilly follows J&J with federal 340B rebate lawsuit
3. 4M people would lose coverage if ACA subsidies expire.
4. Geisinger performs shoulder replacement with a lifetime guarantee.
5. RFK Jr. may seek to rescind AMA’s ability to create billing codes.
6. Indiana residents and feds fight monopolizing hospital merger.
7. CommonSpirit taps into University of Utah Health providers.
8. WHO’s primary care digital transformation handbook.
9. Steward bankruptcy leads to CareMax bankruptcy.
10. RFK Jr. weighs changes on Medicare reimbursement.