FDA Keeps Pace on AI Approvals | Is AI Safe? August 12, 2024
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“I would argue that PACS as we knew it 10 years ago is indeed dead.”
Herman Oosterwijk, on Don Dennison’s prediction 10 years ago of the demise of PACS.
What’s in store for radiology with CMS’ release of its proposed Medicare Physician Fee Schedule for 2025? Radiology scored a few victories, but the agency’s proposal also includes a nearly 3% reimbursement reduction. We talked about the changes with Sandy Coffta of Healthcare Administrative Partners in this episode of The Imaging Wire Show.
The FDA has updated its list of AI- and machine learning-enabled medical devices that have received regulatory authorization. The list is a closely watched barometer of the health of the AI sector, and the update shows the FDA is keeping a brisk pace of authorizations.
The FDA has maintained double-digit growth of AI authorizations for the last several years, a pace that reflects the growing number of submissions it’s getting from AI developers.
Indeed, data compiled by regulatory expert Bradley Merrill Thompson show how the number of FDA authorizations has been growing rapidly since the dawn of the medical AI era in around 2016 (see also our article on AI safety below).
The new FDA numbers show that …
The FDA has now authorized 950 AI/ML-enabled devices since it began keeping track
Device authorizations are up 15% for the first half of 2024 compared to the same period the year before (107 vs. 93)
The pace could grow even faster in late 2024 – in 2023, FDA in the second half authorized 126 devices, up 35% over the first half
At that pace, the FDA should hit just over 250 total authorizations in 2024
This would represent 14% growth over 220 authorizations in 2023, and compares to growth of 14% in 2022 and 15% in 2021
As with past updates, radiology makes up the lion’s share of AI/ML authorizations, but had a 73% share in the first half, down from 80% for all of 2023
Siemens Healthineers led in all H1 2024 clearances with 11, bringing its total to 70 (66 for Siemens and four for Varian). GE HealthCare remains the leader with 80 total clearances after adding three in H1 2024 (GE’s total includes companies it has acquired, like Caption Health and MIM Software). There’s a big drop off after GE and Siemens, including Canon Medical (30), Aidoc (24), and Philips (24).
The FDA’s list includes both software-only algorithms as well as hardware devices like scanners that have built-in AI capabilities, such as a mobile X-ray unit that can alert users to emergent conditions.
Indeed, many of the authorizations on the FDA’s list are for updated versions of already-cleared products rather than brand-new solutions – a trend that tends to inflate radiology’s share of approvals.
The Takeaway
The new FDA numbers on AI/ML regulatory authorizations are significant not only for revealing the growth in approvals, but also because the agency appears to be releasing the updates more frequently – perhaps a sign it is practicing what it preaches when it comes to AI openness and transparency.
MRI Access and the Cost of Inpatient Stays
Longer inpatient stays due to delayed MRI access are a long-standing and costly issue for hospital systems. Find out how STAGE from SpinTech MRI can reduce your MRI backlog and inpatient stays by shortening brain scan times by 30%.
MRI of the Pelvis and Lower Extremities
Join Donald Resnick, MD, and guest faculty in this Virtual Conference series on MRI of the pelvis and lower extremities, hosted by Medality from September 30-October 4. Register your team and save on your group enrollment.
The Wire
AI Appears Safe: The number of FDA AI approvals is growing, but how safe are the AI products that are getting onto the market? A new analysis by legal expert Bradley Merrill Thompson examines medical device reports (MDRs) submitted to the FDA (typically filed when something goes wrong) and suggests that AI is pretty safe. Thompson compared MDRs filed for AI/ML-enabled devices with those for all other medical devices, finding that “AI devices are currently producing fewer MDRs than the medical device universe in general.”
Limited Access to Breast MRI: A new study in American Journal of Preventive Medicine documents how people in rural areas have less access to supplemental breast imaging technologies like MRI and ultrasound. Researchers from the Harvey L. Neiman Health Policy Institute found that travel distances to breast MRI centers were farther in rural areas than metropolitan areas (43 vs. 11 miles), and low-income areas were 2.8X farther from breast MRI centers compared to mammography. Instead of MRI, rural areas could offer contrast-enhanced mammography for supplemental imaging.
DTI-MRI Detects ‘Hidden’ Concussion: U.K. researchers found that MRI with a diffusion tensor imaging (DTI) protocol worked better than blood tests in predicting patients who might have mild traumatic brain injury (mTBI) that goes undetected on CT. In a study of 1k patients in eClinical Medicine, researchers found that adding DTI-MRI to workup better predicted which patients would have “hidden” concussion, with higher AUC than serum biomarkers (0.82 vs. 0.69). DTI-MRI should be added to the workup of individuals with suspected concussion.
One-Stop-Shop CT Stroke Protocol: Researchers in China found in Clinical Radiology that a one-stop-shop protocol with 512-slice CT worked well in assessing patients with suspected acute ischemic stroke. Using Neusoft Medical’s NeuViz Epoch scanner, they scanned 100 patients, finding that those who got the combined one-stop CT brain perfusion and head-and-neck CTA protocol had lower contrast dose (80 vs. 100 mL), 28% shorter scan times (2.32 vs. 3.23 minutes), and lower radiation dose (4681 vs. 5129 mGy.cm). There were no differences in image quality.
Ambulatory PET Gets Moving: You’ve heard of mobile PET, but how about ambulatory PET? In a paper in NatureCommunications Medicine, researchers from West Virginia and California describe Ambulatory Motion-enabling PET (AMPET), a helmet-type PET device that can conduct brain scans while a person is walking upright. They tested AMPET with FDG scans of 11 healthy volunteers and compared brain function while walking in place versus standing still; the scanner passed validation tests that included metrics such as motion artifacts. AMPET probably will be mostly used for brain research.
Attralus’ Amyloidosis Breakthrough: Attralus’ investigational PET imaging agent, 124I-evuzamitide (AT-01), landed FDA Breakthrough Therapy Designation for diagnosing patients with suspected or known cardiac amyloidosis. There are no FDA-approved imaging agents for cardiac amyloidosis, making diagnosis a challenging and time-consuming process. Attralus’ 124I-evuzamitide already received orphan drug designations for the management of ATTR and AL amyloidosis by both the FDA and the European Commission, while its phase 3 trial in patients with suspected cardiac amyloidosis is coming in 2025.
Is PACS Dead? Ten years ago, imaging IT expert Don Dennison wrote a thought-provoking article in Journal of Digital Imaging predicting that PACS would be dead by 2018. In a new column, Herman Oosterwijk takes a look at this forecast, finding that while some predictions were overly optimistic – like broad implementation of enterprise imaging – others were prescient, like the adoption of vendor-neutral archives, cloud-based PACS, and Web-enabled image access. Herman O concludes that the PACS as we knew it in 2014 is indeed dead, replaced by newer technologies.
Power Down PCs to Cut Carbon Emissions: Radiology relies heavily on computer workstations for image review and other functions, and a new analysis in Clinical Radiology shows that powering down PCs can cut carbon emissions without disrupting workflow. U.K. researchers implemented an automatic shutdown protocol for 88 workstations at their facility, finding that average weekly workstation on-time fell 49% (148 to 76 hours). This equates to an annual energy savings of 17 MWh, equivalent to 3.4 tons of CO2 and annual savings of $6,380.
Strategic Radiology Hits Milestone: Independent radiology coalition Strategic Radiology hit a growth milestone last week, adding its 40th practice, Wake Radiology in Raleigh, North Carolina. The practice operates 14 locations in the Research Triangle Park area, and has over 60 radiologists on staff. Strategic Radiology has positioned itself to independent radiology groups as an alternative to selling out to national radiology firms.
PACT Act’s Success: The implementation of the PACT Act in 2022 has given thousands of U.S. military veterans access to expanded health benefits if they were exposed to toxic hazards during their service. A research letter in JAMAdetails the magnitude of the expansion, noting that from August 2022 to June 2024 total VA enrollment grew 15% compared to the previous 21 months, and 5.6M veterans received toxic hazard screenings through June 2024. Medical imaging can be used to screen and diagnose veterans with toxic exposures.
KA Brings X-Ray to Kenya: Canadian X-ray vendor KA Imaging is bringing its Reveal 35C digital radiography technology to Kenya to improve access to medical imaging in remote regions. KA is partnering with the Kenyan Kids Foundation Canada to first install a Reveal 35C detector in a portable system at a rural hospital, and then develop a mobile X-ray van to provide imaging services to northern Kenya. Reveal 3DC can perform dual-energy subtraction imaging, which KA believes has advantages for multiple clinical applications.
Are RTs Professionals? ASRT is asking radiologic technologists to weigh in on an update by the U.S. Office of Management and Budget (OMB) to how it classifies healthcare workers, including RTs. OMB is updating its Standard Occupational Classification (SOC) manual, and ASRT is asking the agency to revise its occupational definitions to classify RTs as “professionals,” a classification already enjoyed by radiation therapists. Comments are due August 12, so don’t delay.
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.
Automated Weight-Bearing Foot Measurements
Learn how Gleamer’s BoneMetrics AI software was able to provide automated measurements on weight-bearing radiographs with high levels of accuracy in a paper published in Skeletal Radiology.
Valley Radiology’s Case for IntelePACS
See how Valley Radiology’s decision to make Intelerad IntelePACS its single reading environment helped the independent practice gain control of its growing volumes and rising case complexity, improve its efficiency and radiologist experience, and deliver better patient care.
The Resource Wire
Enhancing Patient Experience and Streamlining Operations: Jefferson County Health Center transformed their image exchange, saving over 1,000 staff hours annually. This shift improved radiology patient satisfaction scores by 7.6%. Learn how JCHC enhanced patient care and operational efficiency with PocketHealth.
AI-Powered Informatics to Drive Healthcare Value: The DeepHealth OS is a cloud-native operating system that orchestrates all data to drive value across the healthcare enterprise. Learn more about how DeepHealth elevates the radiologist beyond radiology and across the entire care pathway.
Preparing for the Future of Enterprise Imaging: Check out this white paper from Optum to learn what you need to know when moving your enterprise imaging to the cloud. Learn how to assess the various approaches and develop a strategy that works for you.
Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on August 16 features Arjun Kalyanpur, MD, of Teleradiology Solutions – reserve your seat today.
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.
Clinical Excellence on the Move: Healthcare providers are striving to deliver faster, better care for patients, no matter where they are. Learn how the MAGNETOM Viato.Mobile 1.5T MRI scanner from Siemens Healthineers delivers high-quality care where your services are needed most.
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.
Finding Flexibility with AI in the VA: Learn how Blackford is helping the Veterans Health Administration evaluate and onboard multiple on-premise Al applications, supported by monitoring and reporting tools to help clinicians and administrators realize AI’s value.
Top 5 Benefits of Standardizing Medical Imaging Archives: Efficient data management is crucial for delivering quality patient care and achieving organizational goals. But data migration when transitioning to a new PACS can be daunting. Find out how solutions from Enlitic can streamline the process.
Drivers of AI Usage in Radiology: Radiologists are being asked to read more, read faster, and with a higher degree of accuracy as imaging data grows in volume and complexity. In this video from Riverain Technologies, listen to Bernardo Bizzo, MD, and Riverain CEO Steve Worrell explain how this is driving AI usage.
How to Help Radiologists Thrive: With burnout and staffing shortages on the rise, and the increasing volume of imaging, radiology teams are searching for solutions. This interactive guide from Nuance can help you create an environment where radiologists thrive by building a powerful imaging strategy with AI-driven, real-time intelligence.
Top-Tier Care at Rural Hospitals: Holzer Health System in Jackson, OH, treats local patients like family. In this video, learn how United Imaging equipped Holzer Health with its uMR 570 MRI scanner, helping them to offer top-tier care.
Smart Bytes on Cardiology Workflows: Check out Smart Bytes, a new series of webcasts giving you bite-sized insights for smarter imaging from AGFA HealthCare. At 12:30 ET on August 15 learn about improved cardiology workflows using cutting-edge AI technology.
4 Reasons Why Subscription Is Better: The KLAS-leading Intuition advanced visualization solution from TeraRecon includes all the clinical features you need, plus a growing list of exclusive subscription-only content. Learn more about what’s included.
Delivering on PACS Innovation: For over 20 years, Merge by Merative has delivered on PACS innovation. Merge PACS simplifies physicians’ reading activities, helps scale care delivery, and improves reading workflows across the enterprise. Learn more about Merge PACS today.
Visage’s Top 5 Topics from SIIM 2024: What were the hot topics from SIIM 2024? Check out this article from Visage Imaging that breaks down the biggest trends in National Harbor, MD, from the growth of cloudPACS to spatial computing.
