Cameron Andrews of Sirona Medical, on the Apple Vision Pro headset and radiology.

The launch of the Apple Vision Pro headset ushered in the era of spatial computing — a new paradigm for interacting with digital images and data. What does spatial computing mean for radiology? We explore this question with Cameron Andrews, founder and CEO of Sirona Medical, in this episode of The Imaging Wire Show.

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Artificial Intelligence

Is Radiology’s AI Edge Fading?

Is radiology’s AI edge fading, at least when it comes to its share of AI-enabled medical devices being granted regulatory authorization by the FDA? The latest year-to-date figures from the agency suggest that radiology’s AI dominance could be declining. 

Radiology was one of the first medical specialties to go digital, and software developers have targeted the field for AI applications like image analysis and data reconstruction.

• Indeed, FDA data from recent years shows that radiology makes up the vast majority of agency authorizations for AI- and machine learning-enabled medical devices, ranging from 86% in 2020 and 2022 to 79% in 2023. 

But in the new data, radiology devices made up only 73% of authorizations from January-March 2024. Other data points indicate that the FDA …

• Authorized 151 new devices since August 2023
• Reclassified as AI/ML-enabled 40 devices that were previously authorized 
• Authorized a total of 882 devices since it began tracking the field 

In an interesting wrinkle, many of the devices on the updated list are big-iron scanners that the FDA has decided to classify as AI/ML-enabled devices. 

• These include CT and MRI scanners from Siemens Healthineers, ultrasound scanners from Philips and Canon Medical Systems, an MRI scanner from United Imaging, and the recently launched Butterfly iQ3 POCUS scanner. 

The additions could be a sign that imaging OEMs increasingly are baking AI functionality into their products at a basic level, blurring the line between hardware and software. 

The Takeaway

It should be no cause for panic that radiology’s share of AI/ML authorizations is declining as other medical specialties catch up to the discipline’s head start. The good news is that the FDA’s latest figures show how AI is becoming an integral part of medicine, in ways that clinicians may not even notice.

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.

Presenting Unboxing AI

Check out CARPL’s brand-new video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode features AI expert Dr. Osvaldo Landi of FIDI on May 17 – reserve your seat today.

The Wire

• AI Med Postpones 2024 Show: Organizers of the AIMed24 show have announced postponement of the meeting, which had been scheduled for May 29-31 in Florida. Organizers said the decision was made due to “industry trends, market conditions,” and stakeholder feedback, and said it would be rescheduled for later in the year. The 2023 edition of the show drew some 1.5k attendees and dozens of exhibitors including imaging AI vendors, but since then there’s been a documented pullback in venture capital investment in AI.

• Cosmetics and MRI Artifacts: Commonly used consumer products like cosmetics can contain iron oxide or metal particles that cause artifacts on MRI scans. Researchers in Journal of Radiation Research and Applied Sciences tested 22 different personal products with MRI phantoms, finding that 73% created artifacts ranging from mild to severe that could lead to misdiagnosis. They recommended giving patients checklists prior to their exams advising them to refrain from wearing certain personal products and cosmetics, advice that was seconded in a follow-up research letter. 

• MRI for Heart Failure in Women: UK researchers fine-tuned cardiac MRI scanning protocols to make them more sensitive for detecting heart failure with preserved ejection fraction in women, who are disproportionately affected by HFpEF. Researchers in European Heart Journal Open tested their noninvasive technique for measuring pulmonary capillary wedge pressure in 454 patients, finding their sex-specific PCWP protocol better predicted heart failure hospitalization (HR=3.9) and MACE (HR=2.4) than generic cardiac MRI that didn’t take gender into account.  

• Is CTA Overused in Younger Women? Heart disease is the number-one killer of women, but is coronary CT angiography overused when working women up for cardiac problems? Researchers in a paper in International Journal of Cardiology studied 1.9k men and women, finding the negative CTA rate was higher in females (45% vs. 27%) and particularly in women younger than 47 (83% vs. 68%) while obstructive disease prevalence was similar (4.6% vs. 6.5%). Risk-prediction tools should be used to better select younger women for CCTA.  

• Study Clears CAC/Exercise Connection: A new research study found no association between high volumes of physical activity and excessive buildup of coronary artery calcium. Previous research suggested a link, so researchers in JAMA Cardiology acquired CT-based CAC measurements in 8.8k healthy people who met criteria for high physical activity (with vigorous exercise classified as high-intensity activity for 5 hours/week). They found no association between activity and progression to clinically significant CAC, defined as 100 or more Agatson units. So go ahead and hit the cardio circuit again.

• GE Links with Medis for Quantitative Angio: GE HealthCare has signed a deal with Dutch cardiac imaging software developer Medis Medical Imaging to integrate its Medis Quantitative Flow Ratio quantitative angiography application into GE’s Allia interventional cardiology platform. Medis QFR is a noninvasive tool for assessing coronary artery physiology in the cath lab; a recent study found that use of Medis QFR can reduce myocardial infarction and the need for revascularization compared to standard angio guidance. 

• Signify Sees C-Arm Growth: Signify Research estimates that the global C-arm market will grow from $4.2B in 2023 to $5B by 2028, as both the interventional X-ray and mobile C-arm segments maintain steady growth (+3.9% and +5.2% annually). The market is shifting from image intensifiers to flat-panel detectors, and the report predicts growth in the 3D C-arm market. Cardiology will be the fastest-growing interventional segment, while in radiology interventional neurology will see demand grow thanks to the expansion of stroke centers.

• Butterfly Branches Out: Handheld ultrasound developer Butterfly Network is branching out by launching its first specialty medical device, iQ+ Bladder. The cart-based system includes an ultrasound probe and software designed to help nurses rapidly collect automated bladder volume calculations with 3D visualizations. The debut comes on the heels of the company’s launch of its third-generation Butterfly iQ3 probe in January 2024.

• RSNA Advances New Journal: RSNA has published the first edition of a new open-access journal – Radiology Advances – intended to make available peer-review research that’s “transparent and timely.” The first edition features eight articles on a range of topics, including ChatGPT-4 for analyzing ultrasound images, deep learning reconstruction for super-resolution coronary CT angiography, and 7T knee MRI. 

• Annalise Lands UK Deals: AI developer Annalise.ai has signed an agreement to deploy its solutions for analyzing chest X-rays and non-contrast CT brain scans at Doncaster and Bassetlaw Teaching Hospitals in the UK. The system operates three primary hospitals with 7k health professionals who serve 440k people; Annalise’s technology will flag, highlight, and prioritize cases based on urgency. In another UK deal, Annalise signed an agreement to integrate its technology into UK software developer Soliton’s Radiology+ RIS platform and Share+ application.

• CT-Based Osteoporosis Test: Osteoporosis AI developer BDI is touting results of a clinical study published in Osteoporosis International using the company’s software to detect osteoporosis from routine CT scans. Emory researchers tested the application’s ability to perform opportunistic screening in a population of 6.8k individuals, finding that those who had signs of osteoporosis on vertebral trabecular BMD (vBMD) scans had higher risk of a first hip fracture (HR=1.57) and first vertebral fracture (HR=2.93). 

• Are Doctors Responsible for AI? The Federation of State Medical Boards recently took the stance that doctors are responsible for their use of AI and accountable for any harm stemming from that use. The report states that physicians shouldn’t depend on AI and must always be able to explain why they followed a tool’s advice, a view that the American Medical Association agrees with despite holding a different opinion on liability. States are currently considering their medical boards’ input on regulating AI, with final decisions expected in the coming months.

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.

Get to Know DeepHealth

What’s the latest from DeepHealth? In this episode of the Imaging Wire Show, we talked to COO and CTO Sham Sokka about the company’s recent launch and their take on the value AI provides to radiology, especially for screening.

Celebrating Happy Customers

There’s nothing better than happy customers. Find out what radiology personnel at Western New York MRI in Buffalo had to say about their new uMR 680 scanner from United Imaging.

The Resource Wire

• Overcoming a Complex Image Exchange Workflow: Guadalupe Regional Medical Center (GRMC) and Methodist Hospital implemented a PocketHealth Community Gateway that saved over 1,700 staff hours. Find out how they did it.

• The Complete Guide to Radiology AI: Radiology is leading healthcare’s AI revolution, and yet many people in radiology are just starting to build their understanding of AI. That’s why Bayer published its truly Complete Guide to Artificial Intelligence in Radiology, detailing how AI can address radiology’s challenges, AI’s core use cases, and AI’s path towards adoption.

• Learn about the Benefits of CloudPACS: CloudPACS has finally arrived. Learn more about the benefits that cloud-based PACS can have for your radiology practice and how Visage Imaging’s Visage 7 was built from the ground up to ensure maximum performance, security, and scale. 

• Strategic Planning for Radiology Groups: The pressures on radiology groups have never been more intense. In this May 21 webinar hosted by Medality, you’ll learn why strategic planning is important, how to start doing the planning process, and how to position yourself and your group for success. 

• Your Single Solution for AI, 3D, and Full Interoperability: Realize immediate value across your organization with subscription-based advanced visualization and AI from TeraRecon that accelerates imaging workflows and improves patient outcomes. Schedule a demo today. 

• AI-Automated Heart Failure Detection from EHRs: New research shows the feasibility of using Us2.ai’s echo AI solutions to automatically identify patients with heart failure from archived echo images in the EHR. Learn how it works in this study in European Journal of Heart Failure. 

• AI-Based X-Ray Fracture Analysis: Gleamer’s BoneView AI fracture analysis tool performed well in detecting distal radius fractures on musculoskeletal radiographs in a study published in BMJ. Learn more in this study summary.

• 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.

• 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.  

• 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 and keep your eyes peeled for an update later this year.

• Radiology Data Standardization with AI: Enlitic offers healthcare providers a transformative approach to patient care, operational efficiency, and resource utilization. Learn how the company’s ENDEX solution can help you generate a return on investment through AI-based radiology data standardization. 

• 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. 

• Clearer MRI for Alzheimer’s Disease: Clinicians and patients are encouraged by new drugs available to slow or reduce cognitive decline and Alzheimer’s disease. Learn how 30% faster MRI scans and clearer images enabled by SpinTech MRI’s STAGE software can help address imaging challenges. 

• Revolutionizing Healthcare Imaging: Learn about Intelerad’s role in healthcare innovation, the importance of “ditching the disk,” and more in this interview with President Morris Panner on the Skeleton Crew: The Rad Tech Show.