Regulatory

FDA strikes down radiology AI 510(k) exemption arguments
By Liz Carey
Regulator rejects broad statement of user capabilities in detecting performance issues.
April 13, 2026
Business Regulation Graphic Social Resized (1)
FDA accepts Telix NDA for glioma PET agent Pixclara
By AuntMinnie.com staff writers
The NDA resubmission included additional data and statistical analysis requested by the U.S. FDA.
April 10, 2026
Pet Brain Scan Adobe Michael dim5r Awl G7
Bayer gets first approval for gadoquatrane in Japan
By AuntMinnie.com staff writers
Bayer received approval from Japan's Ministry of Health, Labour, and Welfare for its low-dose macrocyclic gadolinium-based contrast agent gadoquatrane.
March 24, 2026
Bayer
Telix resubmits NDA for Pixclara brain cancer PET imaging agent
By AuntMinnie.com staff writers
The New Drug Application (NDA) resubmission includes additional data and statistical analysis requested by the U.S. FDA.
March 17, 2026
Pet Brain Scan Adobe Michael
FDA moves to quickly replace adverse event reporters
By AuntMinnie.com staff writers
The U.S. FDA has launched a single platform for analyzing adverse event reports across all product categories the agency regulates.
March 11, 2026
Fda Button Social
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
Fetal Ultrasound
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
Acr Logo 2023
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
Ai Logo k D4 Gat9j Hn
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
Fda Sign Dc
Triad Radiology data breach affects more than 11K patients
By AuntMinnie.com staff writers
The hacking incident occurred in mid-2025.
February 20, 2026
Cyberattack Hacker
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
Guerbet Rsna 2019 400 jh Wt Mq6 Y3h
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
Mri Scan Brain
Page 1 of 305
Next Page