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Mammo AI Attitudes, Ezra Adds Labs, and Screening Skeptic at FDA May 8, 2025
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Together with
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“No cancer screening test has ever shown overall survival or even all cancer death benefits in a randomized trial. CT screening for lung CA briefly did in [NLST], but that was noise and lost when Pinsky re-examined it.”
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New FDA CBER chief Vinay Prasad, MD, in a 2024 article criticizing cancer screening and whole-body MRI.
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How should radiologists manage incidental CAC findings discovered on routine CT exams? New industry collaborations are making it possible to deliver CAC reports to clinicians without disrupting workflow. Learn more in this contribution from Coreline Soft.
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As radiology moves (albeit slowly) to adopt clinical AI, how do patients feel about having their images interpreted by a computer? Researchers in a new study in JACR queried patients about their attitudes regarding mammography AI, finding that for the most part the jury is still out.
Researchers got responses to a 36-question survey from 3.5k patients presenting for breast imaging at eight U.S. practices from 2023-2024, finding …
- The most common response to four questions on general perceptions of medical AI was “neutral,” with a range of 43-51%.
- When asked if using AI for medical tasks was a bad idea, more patients disagreed than agreed (28% vs. 25%).
- Regarding confidence that medical AI was safe, patients were more dubious, with higher levels of disagreement (27% vs. 20%).
- When asked if medical AI was helpful, 43% were neutral but positive attitudes were higher (35% vs. 19%).
The Takeaway
Much like clinicians, patients seem to be taking a wait-and-see attitude toward mammography AI. The new survey does reveal fault lines – like privacy and equitability – that AI developers would do well to address as they work to win broader acceptance for their technology.
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In a major development in the wellness-screening segment, diagnostic lab screening company Function Health acquired full-body MRI firm Ezra. The companies plan to offer wellness screening that combines lab tests with imaging.
Ezra launched in 2018 with an initial focus on prostate MRI but soon expanded into full-body MRI screening.
- The company has developed AI-enhanced image acceleration algorithms to acquire MRI scans in shorter time slots, enabling it to drive down costs to consumers.
Ezra’s scans are currently available at 100 U.S. locations with the goal of 1k sites in coming months (the company doesn’t run its own centers, but rather partners with existing imaging providers like AMRIC Health).
- Function Health has a similar strategy but in the clinical diagnostics space, offering blood tests available through some 2.2k Quest Diagnostics locations.
Function and Ezra believe that combining lab tests with imaging will support a new level of wellness screening that when coupled with AI will be even more predictive.
The Takeaway
The combination of Function Health and Ezra is an interesting wrinkle in the wellness screening space that promises to make screening even more comprehensive by acquiring both lab and imaging data. The question is whether other screening providers will feel compelled to follow suit.
We’re testing a new format today – let us know if you prefer two shorter Top Stories or one longer Top Story with this quick survey!
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Aortic Stenosis AI Echo Assessment
In a first-of-its-kind study, AI echo from Us2.ai accurately quantified aortic stenosis severity with no human input beyond image acquisition. Learn more about this important research today.
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AI-Powered Early Breast Cancer Detection
DeepHealth parent RadNet is expanding its presence in mammography AI with its pending acquisition of iCAD. Find out how the transaction will accelerate AI-powered early detection and diagnosis of breast cancer on this page.
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Enterprise Imaging in the Cloud
What are the benefits of cloud-based enterprise image management? Check out this Imaging Wire Show interview with Tracy Byers, CEO of enterprise imaging at Optum, on the importance of the cloud in radiology.
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- Cancer Screening Skeptic to Lead FDA Division: Cancer screening skeptic Vinay Prasad, MD, was named to lead the FDA’s Center for Biologics Evaluation and Research after its previous chief was forced out by the Trump Administration. An oncologist known for controversial views on topics like COVID-19 vaccination, Prasad has criticized cancer screening and in particular whole-body MRI screening, such as in a 2024 article. CBER regulates vaccines and other biological products and has little purview over medical devices – perhaps fortunately for radiology.
- Cardiac MRI Beats Echo for AS Prediction: 4D flow cardiac MRI was better than transthoracic echocardiography for predicting which aortic stenosis patients would require intervention. In a study in Open Heart of 30 patients, U.K. researchers found that 4D flow measures of peak aortic valve jet velocity predicted whether patients would need catheter- or surgery-based intervention (HR=2.51), while TTE-based continuous wave Doppler measurements had no statistically significant association. Echo is far cheaper and more widely available than cardiac MRI, however.
- AI Detects Interval Breast Cancer Earlier: ScreenPoint Medical’s Transpara AI algorithm was able to detect breast cancers that were originally missed by radiologists but detected on later mammograms – so-called interval cancers. In a study in JNCI, researchers analyzed 148 interval breast cancers from 185k mammograms, finding that Transpara flagged 76% of mammograms originally read as normal and 90% of cases where cancers were visible but misinterpreted. It detected 50% of true interval cancers – those where cancers were not visible at screening but developed later.
- Enlitic Secures GE Revenue Stream: Data standardization firm Enlitic signed an agreement with GE HealthCare that puts a dollar amount on the data migration partnership they announced earlier this year. Enlitic’s Laitek subsidiary will deliver data migration services to GE worth USD$3M-$6M annually over the next five years. The partnership is contingent on Enlitic raising a minimum of USD$6.5M from external sources, a move it is in the process of completing through commitments from new and existing investors.
- DECT Protocol Reduces Radiation, Contrast Dose: Researchers reduced both radiation and contrast dose in CT scans for pulmonary embolism using a BMI-based dual-energy CT scanning protocol. In a study in Clinical Radiology, researchers found that in scans of 90 people, researchers adjusted CTPA tube current as well as contrast volume and injection rate based on patient BMI, finding it reduced radiation dose 29-36% and contrast volume 54%. A recent study focused attention on cancer risk from CT radiation, while less contrast lowers the rate of contrast-induced kidney injury.
- Microsoft Taps Philips to Replace SpeechMic: Microsoft is retiring its Nuance PowerMic dictation microphone, and is recommending the Philips SpeechMike Premium Touch device as a replacement. Nuance PowerMic has been used by clinicians including radiologists for dictating clinical notes and reports, but Microsoft is retiring the mic in coming weeks. Philips notes that SpeechMike is already in use by millions of medical, legal, and business professionals worldwide.
- Philips Predicts $340M Tariff Hit: Philips is the latest multimodality OEM predicting tariffs to hit their business. In their announcement of Q1 earnings, the company expects tariffs to reduce full-year 2025 earnings by up to $340M, higher than previously expected. Philips also said they are taking steps to bolster their supply chain in the expectation that trade wars could interrupt components needed to assemble medical equipment. In Q1 numbers, their Diagnosis & Treatment division saw revenues fall 4% to $2.23B on lower China sales.
- Siemens Adjusts Tariffs Estimate: Meanwhile, Siemens Healthineers adjusted their estimate of the impact tariffs will have on their business, which they now believe will reduce annual earnings by up to $340M. Siemens Healthineers also posted Q2 financial results in which their Imaging business saw revenues grow 8.7% to $3.73B after adjusting for currency effects.
- Lunit Lands Big German AI Contract: Lunit received a five-year contract to provide their AI solutions to Starvision Service, Germany’s largest private radiology network. Starvision operates 79 imaging sites, and will adopt Lunit AI solutions for chest X-ray, 2D and 3D mammography, and fracture detection. The Lunit products are already in use at several Starvision sites, with more deployments to follow.
- CT Lung Screening Follow-Up: As large-scale CT lung cancer screening programs get started, how should suspicious findings be followed up? In a new paper in European Radiology, U.K. researchers found that across 8.8k individuals, 113 people had suspicious findings. Short-term follow-up CT scans at six weeks rather than PET/CT or surgery were ordered, and 57% of cases resolved spontaneously at six weeks. In the rest, malignancies were found in only 13 patients. Short-term CT would save $63k for every 10k people screened.
- SHINE to Buy Lantheus SPECT Tracers: SHINE Technologies reached an agreement to acquire Lantheus’ SPECT radiopharmaceutical business, including molybdenum-99m, a widely used radiotracer that’s the precursor element for technetium-99m products for nuclear cardiology exams, such as Cardiolite. SHINE will produce Mo-99 as well as lutetium-177 at its Chrysalis large-scale irradiation facility in Wisconsin, scheduled to open in 2026. Lantheus plans to focus on its PET radiopharmaceuticals and theranostics agents acquired through its acquisitions of Life Molecular Imaging and Evergreen Theragnostics.
- FDA Clears GE SPECT/CT: The FDA cleared GE HealthCare’s Aurora dual-head SPECT/CT scanner, which the company unveiled at RSNA 2024, as well as its Clarify DL AI-powered data reconstruction algorithm. Aurora sports 40mm detector coverage and a 128-slice CT component, making it suited for clinical applications including cardiology, oncology, and neurology. It also is available with 5/8-inch NaI scintillator crystals for use with a wide range of radiopharmaceuticals.
- Harrison.ai Taps Duncan to Lead Growth: Annalise.ai parent Harrison.ai has named imaging industry executive Josh Duncan as chief growth officer, Americas. Duncan previously was with Rad AI, where he led the company’s sales and marketing effort. Harrison.ai is making a major push into the U.S. and the broader Americas market, fueled by the company’s recent $112M Series C funding round, and Duncan will lead operations across the region.
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Give Patients a Clear Path to Accessing Medical Data
Clearpath is a simple integration that empowers digital delivery of medical records and images. Request a demo today to find out how you can ditch the disc and give your patients and third parties instant access to digital data.
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Presenting Unboxing AI
Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on May 8 features Ángel Alberich Bayarri of Quibim – reserve your seat today.
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- Start at the Source to Improve MRI: Looking for ways to improve MRI speed and image quality while addressing broader concerns in healthcare? The answer may lie in proven MRI physics in your existing scanner – learn how to unlock it with STAGE from SpinTech MRI.
- Connect with Intelerad at SIIM 2025: Join Intelerad at booth #533 at SIIM 2025 to learn how they are redefining healthcare imaging with innovative solutions designed to provide a clear path to answers. Schedule your visit today.
- Achieve More with AI You Can Trust: Visit Microsoft at SIIM 2025 to experience how Microsoft Cloud for Healthcare can empower your workforce and unlock insights. Request a meeting or stop by at booth #314-316.
- The Transformative Role of AI in Radiology: In this episode of The Radiology Report podcast, Medality’s Daniel Arnold sits down with Dr. John Simon, who shares his insights into the transformative role of AI in radiology and its ability to enhance efficiency, improve patient care, and unlock new diagnostic possibilities.
- Connect with Calantic by Bayer at SIIM 2025: Visit Calantic by Bayer at SIIM 2025 to learn how they are helping clinicians leverage radiology AI to enhance the patient experience. See their schedule of presentations or book at meeting today at booth #231-235.
- A New Resource for AI of MRI: Gleamer is expanding into AI of MRI with its acquisition of innovative AI developers Pixyl and Caerus Medical. Learn how the company is creating the most comprehensive AI portfolio for medical imaging.
- Meet Merge at SIIM 2025: Merge puts your workspaces, clinicians, and imaging transformation into focus. Explore their market-leading solutions at SIIM 2025 at booth #632, or schedule your visit today.
- Visit Kailo Medical at SIIM 2025: Learn about the latest synoptic reporting solutions by visiting Kailo Medical at booth #539 at SIIM 2025. Book an appointment today to find out how their technology can make radiology reporting easier while maximizing efficiency.
- Top 3 Productivity Tools for Radiologists: Radiologists today face growing demands for speed, collaboration, and accuracy. Attend this May 8 webinar to learn from clinical and IT leaders from the University of Michigan Health – Sparrow and AGFA HealthCare as they share the top tools helping radiologists work smarter.
- Visit United Imaging at ISMRM 2025: United Imaging is reaching new clinical heights in MRI with new innovations like 5T MRI and its uAiFI technology. Visit the company at ISMRM 2025 at booth #A18 or attend one of its conference events.
- Unprecedented Insights Made Possible with AI: With the largest normative dataset of whole-body imaging in the world, Prenuvo’s AI researchers partner with the best academic minds to understand – like never before – what “normal” aging means. Learn about their work today.
- Visit Philips at ISMRM 2025: Philips will be showcasing its AI-driven connected imaging, optimized workflows, and integrated clinical solutions for MRI at ISMRM 2025. See their conference highlights or drop by at booth #D41.
- The Benefits of Operational AI: Explore the transformative potential of operational AI in healthcare in this on-demand webinar hosted by Blackford. Learn from the company’s partners how AI can help your practice operate more efficiently.
- Incorporating Digital Pathology in Your Enterprise Imaging Strategy: As digital pathology exams grow in size and complexity, healthcare organizations face increasing challenges. Attend this Mach7 Technologies webinar on May 8 to hear real-world experiences from the University of Michigan on how they unified radiology and pathology.
- AI Tools for Lung Cancer Screening: CT lung cancer screening is gaining momentum around the world. Learn about AI-based nodule detection tools that can improve the accuracy of low-dose CT scans in this video from Riverain Technologies.
- Visit Enlitic at SIIM 2025: Visit Enlitic at SIIM 2025 at booth #530 to learn about their solutions for data standardization and migration, including their new partnership with GE HealthCare powering the data migration feature in GE’s new Genesis cloud portfolio. Book a demo today.
- Streamlined Workflows Save 1000+ Hours: 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.
- Book a Visage Demo at SIIM 2025: Visage Imaging is trailblazing medical imaging’s SaaS move to the cloud with an open cloud philosophy based on industry standards and multi-cloud support. Learn more by registering for a priority demo at SIIM 2025 or visit them at booths #627-631.
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