FDA

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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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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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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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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FDA expands authorization for UltraSight platform
By AuntMinnie.com staff writers
The U.S. FDA has expanded authorization to allow UltraSight's Echo Stewardship Platform be used across more ultrasound devices.
January 6, 2026
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Petition to U.S. FDA proposes alternative pathway for radiology AI
By Liz Carey
The proposal supports a dynamic, “try-first” culture in the U.S.
January 2, 2026
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mlHealth 360 secures FDA 510(k) for ICH triage tool
By AuntMinnie.com staff writers
mlHealth 360 has received U.S. Food and Drug Administration (FDA) clearance for its Scaida BrainCT-ICH AI-powered triage software.
December 5, 2025
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