The FDA, in its annual update on AI and machine learning-enabled device clearances.

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Artificial Intelligence

FDA Data Show AI Approval Boom

In the previous issue of The Imaging Wire, we discovered how venture capital investment in AI developers is fueling rapid growth in new AI applications for radiologists (despite a slowdown this year). 

This trend was underscored late last week with new data from the FDA showing strong growth in the number of regulatory authorizations of AI and machine learning-enabled devices in calendar 2023 compared to the year before. The findings show:

• A resurgence of AI/ML authorizations this year, with over 30% growth compared to 14% in 2022 and 15% in 2021 – The last time authorizations grew this fast was in 2020 (+39%)
• The FDA authorized 171 AI/ML-enabled devices in the past year. Of the total, 155 had final decision dates between August 1, 2022 to July 30, 2023, while 16 were reclassifications from prior periods 
• Devices intended for radiology made up 79% of the total (122/155), an impressive number but down slightly compared to 87% in 2022 
• Other medical specialities include cardiology (9%), neurology (5%), and gastroenterology/urology (4%)

One interesting wrinkle in the report was the fact that despite all the buzz around large language models for generative AI, the FDA has yet to authorize a device that uses generative AI or that is powered by LLMs. 

The Takeaway

The FDA’s new report confirms that radiology AI shows no sign of slowing down, despite a drop in AI investment this year. 

The data also offer perspective on a JACR report last week predicting that by 2035 radiology could be seeing 350 new AI/ML product approvals for the year. Product approvals would only have to grow at about a 10% annual rate to hit that number – a figure that seems perfectly achievable given the new FDA report.

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, chief medical officer of enterprise imaging at Change Healthcare, as she addresses concerns and offers possible solutions that you can use right now.

Power at the Point of Care

Are you ready to upgrade your X-ray technology? Check out United Imaging’s high-performance X-ray systems at RSNA 2023 at Booth #4100 and see the uDR 380i Pro Mobile X-ray system navigate its own obstacle course.

The Wire

• Cyberattack Shuts Centers: Imaging center company Akumin was hit with a cyberattack that forced it to shut down its computer systems and cancel scheduled patient scans. The company said it detected suspicious activity in its IT network that was the result of a recent ransomware incident. Clinical and diagnostic operations at its fixed-site centers have been postponed until systems can be restored. The incident illustrates the growing threat of cyberattacks on healthcare providers.

• Med Students as Coordinators: Putting medical students to work in the radiology reading room as coordinators for non-interpretive tasks like answering phone calls found strong support in a study in Current Problems in Diagnostic Radiology. Researchers recruited medical students to help on-call radiologists, and 89% of them agreed that the coordinators improved efficiency and reduced distractions and stress. Report turnaround time was not affected (36.8 vs. 36.9 minutes), a finding contrary to a recent study in JACR that saw a TAT improvement. 

• PET Tracer Dose Drops in Kids: Great news for children who need PET scans came last week in European Radiology. Over the last 20 years, the radiotracer dose in kids getting PET/CT and PET/MRI scans has fallen 66% with no negative impact on quality. Swiss researchers tracked radiation dose from FDG used to scan 243 children over two periods, 2000-2005 and 2016-2021, finding a statistically significant drop in median FDG activity (296 MBq vs. 100 MBq). The drop is due to technical innovations targeted at reducing radiotracer dose. 

• Subtle Medical Touts Growth: Subtle Medical has seen a surge in demand for its accelerated image processing software in the US and internationally, a trend that has helped the company double its business over the last 12 months. The company credited its partnership approach for enabling it to penetrate new markets in Europe, South America, Canada, and Asia-Pacific regions. In other news, Subtle teased a new product launch, SubtleALLY, designed to address radiology workflow issues by standardizing processes that radiologists currently perform manually. 

• Total-Body PET Probes Immune Response: Researchers from UC Davis used United Imaging’s uEXPLORER total-body PET scanner to image the immune response to COVID-19 infection. In a paper in Science Advances, researchers used total-body PET with a ⁸⁹Zr-labeled CD8-targeted minibody radiotracer in a small group of patients with (N=5) and without (N=3) COVID-19. They noted T cell distribution “with remarkable image quality,” and saw especially high uptake concentration of CD8+ T cells in the bone marrow of recovering patients, perhaps related to “immune memory” after viral infection.

• ChatGTP Answers Patient Questions: More patients are getting direct access to their radiology reports, and many have questions. Can ChatGPT help answer them? In JACR, researchers put the large language model to work on this task, having it answer 22 common imaging-related questions. ChatGPT’s responses were accurate 83% of the time, but fell short of a requirement to provide answers at an eighth-grade reading level. Researchers concluded that the algorithm has potential, but has limitations that require “cautious implementation and further research.” 

• BAC Software Gets Clearance: The FDA has cleared the cmAngio application from CureMetrix for calculating breast arterial calcification (BAC) from digital mammograms. Research studies have linked BAC to cardiovascular disease, so the clearance could make possible opportunistic screening by enabling clinicians to screen for both cancer and CVD from a single mammogram. CureMetrix has steered away from making cardiovascular claims in its cmAngio PR materials, however, other than to say it helps radiologists identify BAC as an “underreported incidental finding” that should be reported.

• GE Signs Diabetes Deal with Novo Nordisk: GE HealthCare has begun working with Novo Nordisk on the use of peripheral focused ultrasound (PFUS) as a treatment for type 2 diabetes and obesity. The partnership is based on research findings in which ultrasound was found to stimulate nerve pathways in a way that could impact glucose metabolism. PFUS could offer a non-pharmacological way to normalize blood glucose levels; GE will offer its ultrasound technology while Novo Nordisk will contribute experience in metabolic disease treatment and management. 

• VA Installs First Photon-Counting CT: The first photon-counting CT scanner in the VA healthcare system has been installed, at the Birmingham VA Health Care System in Alabama. The hospital installed Siemens Healthineers’ Naeotom Alpha scanner, which in 2021 became the first photon-counting CT scanner to win FDA clearance and be commercialized. VA clinicians said the scanner will give Alabama veterans access to the latest medical technology, providing better image quality at a lower radiation dose than existing CT technology. 

• SIIM’s JDI to Get Makeover: SIIM’s Journal of Digital Imaging (JDI) will get a new name and new look starting in January 2024, with the revamped publication to be called Journal of Imaging Informatics in Medicine (JIIM). The redesigned journal will continue to focus on medical imaging informatics and related topics; SIIM announced in November 2022 that Elizabeth Krupinski, PhD, of Emory University would be taking over as editor in chief. 

• Excess Healthcare Cost Analysis: The Commonwealth Fund looked into why US healthcare costs are nearly twice as high per person as other peer nations, and produced a nice breakdown of the leading contributors. Administrative costs were an easy target, with the report specifically calling out processes related to eligibility, coding, and submission. The top factors ranked by their share of excess costs include: health plan administrative costs (15%), provider administrative costs (15%), prescription drugs (10%), and physician wages (10%).

• Real-Time Wrist MRI at 0.55T: A low-field MRI scanner was able to produce real-time images of the wrist in motion, described in a new paper in BJR. Researchers used a Siemens Healthineers high-performance 0.55T MRI scanner to scan five healthy volunteers while they performed wrist maneuvers. A panel of readers rated the image quality of all scans as “good” or “very good” and said images were diagnostic. Researchers said 0.55T MRI could be an alternative to 1.5T or 3T scanners for imaging wrist dysfunction.

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.

How Aster DM Healthcare Leveraged CARPL

See how Dubai-based healthcare leader Aster DM Healthcare leveraged the CARPL platform to connect its doctors, data scientists, and imaging workflows, and support its AI projects and development infrastructure.

Delighting Patients with Medical Image Sharing

A new platform from Clearpath now enables healthcare providers to delight their patients by sharing images and medical records digitally. Find out how it integrates simply into your practice.

The Resource Wire

• Using AI to Assess Coronary Artery Calcification: Learn about the power of the platform to deliver multiple AI solutions in this October 26 webinar sponsored by Nuance. Discover how to optimize your existing data with AI to get more out of routine imaging.

• What Is CPACS in Cardiology? It stands for Cardiovascular Picture Archive and Communication System, and it’s used to store, manage, and share cardiology images. Learn how CPACS can improve patient care in this Intelerad blog post. 

• Learn about Subtle Solutions: How can Subtle Medical’s advanced solutions like SubtleMR and SubtlePET – and upcoming SubtleSYNTH launch – improve image quality, workflow efficiency, and patient care? Find out in this RSNA 2023 Lunch & Learn session at Noon Tuesday November 28. 

• Clinical Decision-Making with CEM: Learn more about contrast-enhanced mammography (CEM) in this GE HealthCare Clinical Conversations webinar on October 25 at 1 pm ET featuring Gaelyn Scuderi, MD. She will discuss impactful cases and the value she sees in CEM while addressing implementation questions.

• Echo AI for Myocardial Strain: Strain imaging is the most sensitive parameter for determining myocardial deformation and systolic left ventricular function. In this video, see how echo AI from Us2.ai was used to analyze myocardial global longitudinal strain. 

• The Advantages of CloudPACS: What are the advantages of CloudPACS? Speed, reliability, and security, with no latency. Learn how Visage Imaging’s Visage 7 PACS was built around the cloud from the ground up in this white paper. 

• 5 Questions about Lung Cancer and AI: Lung cancer causes more deaths globally than colon, breast, and colon cancer combined. But technologies like AI and low-dose CT screening can help. Learn more in this Q&A with Ankur Sharma, MD, head medical affairs digital radiology at Bayer. 

• Leveraging Pediatric Imaging AI: Check out this Blackford Analysis white paper detailing how children’s hospital imaging teams can leverage AI to improve modality throughput and imaging device availability.

• Advanced Imaging Access for All: Patients’ zip codes shouldn’t determine the healthcare they receive. Siemens Healthineers aims to make advanced diagnostic imaging accessible for all patients. Register today for a launch event on November 16 at 12:00 p.m. ET to meet the company’s new Somatom CT family member. 

• Address Your Imaging Needs Today: Looking for a partner to help guide your digital transformation? Face your future with confidence with enterprise imaging solutions from Merge by Merative. Learn more in this white paper. 

• Why Data Standardization for Medical Imaging? Data standardization has emerged as a key issue for both clinical and research aspects of medical imaging. Learn about its pivotal role in healthcare in this Enlitic webinar on October 25 featuring radiologist Cheryl Petersilge, MD, founder and CEO of Vidagos. 

• Overcoming the Radiologist Shortage: How can radiology practices use innovative training and education techniques to grow and overcome the ongoing shortage of radiologists? Find out in this Imaging Wire Show interview with Daniel Arnold and Deanna Heier of Medality.

• How Imaging Partners of OC Eliminated CDs: Imaging Partners of Orange County was using CD-ROMs to share with patients many of the over 70,000 imaging exams they perform annually. Find out how PocketHealth helped them eliminate CDs and provide a better patient experience.