Regulatory

Ultrasound AI nets U.S. FDA clearance for delivery date prediction AI
By AuntMinnie.com staff writers
The software uses deep-learning neural networks to analyze ultrasound characteristics and predict fetal delivery date.
March 2, 2026
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ACR sends FDA a wish list for AI device 510(k) exemption petition
By AuntMinnie.com staff writers
The U.S. FDA is expected to issue a decision soon.
February 27, 2026
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Qure.ai secures FDA clearance for chest x-ray CAD software
By AuntMinnie.com staff writers
Qure.ai has secured clearance from the U.S. FDA for qXR-Detect, a computer-assisted detection (CAD) solution for chest x-rays.
February 27, 2026
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FDA expands Vueway approval to neonates and infants
By AuntMinnie.com staff writers
The U.S. FDA has expanded the approved use of Bracco's Vueway MRI contrast agent to neonates and infants.
February 24, 2026
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Triad Radiology data breach affects more than 11K patients
By AuntMinnie.com staff writers
The hacking incident occurred in mid-2025.
February 20, 2026
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Guerbet secures U.S. FDA approval to expand Elucirem use to neonates
By AuntMinnie.com staff writers
Elucirem is indicated in adults and now in pediatric patients.
February 20, 2026
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NGS proposes denying Medicare coverage for AI-powered brain MRI exams
By AuntMinnie.com staff writers
The ACR is notifying stakeholders of a public hearing on a new policy that would deny Medicare coverage for AI brain MRI exams.
February 5, 2026
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RevealAI-Lung software secures 510(k) clearance
By AuntMinnie.com staff writers
RevealDx has secured 510(k) clearance for its nodule-characterizing RevealAI-Lung software.
February 3, 2026
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Nanox gets FDA clearance for software upgrade
By AuntMinnie.com staff writers
Nanox's TAP2D image enhancement tool for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems has received U.S. FDA clearance.
February 3, 2026
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HHS solicits input on diagnostic image sharing capabilities in U.S.
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) aims to understand current diagnostic quality image-sharing capabilities.
January 30, 2026
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Aidoc secures new FDA clearance for CT triage system
By AuntMinnie.com staff writers
The U.S. FDA has cleared Aidoc's expanded AI triage system BriefCase, with 11 new indications, according to the firm.
January 23, 2026
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LLMs in radiology may find opening in updated FDA guidance
By Liz Carey
The U.S. FDA has released updated guidance that could pave the way for wider use of large language models (LLMs) in radiology.
January 8, 2026
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