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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
Radical Catheter Technologies gets FDA clearance for 6F catheter
By
AuntMinnie.com staff writers
6F is the company's third FDA-cleared catheter.
April 13, 2026
Sirtex reports that DOORwaY90 study shows 100% tumor control for HCC
By
AuntMinnie.com staff writers
The results were presented in an oral presentation at the Society of Interventional Radiology Annual Meeting in Toronto.
April 13, 2026
FDA reminds sponsors, researchers to disclose clinical trial results
By
AuntMinnie.com staff writers
Studies subject to mandatory reporting include interventional studies with a U.S. nexus and an FDA-regulated product that are past the deadline to report.
April 13, 2026
Microbot Medical launches Liberty robotic system nationwide
By
AuntMinnie.com staff writers
Liberty has been used commercially across a range of procedures.
April 13, 2026
ARRS honors Kruskal, Katz with 2026 Gold Medal
By
AuntMinnie.com staff writers
The American Roentgen Ray Society (ARRS) has awarded its highest honor to Jonathan Kruskal, MB, ChB, PhD, and Douglas Katz, MD.
April 13, 2026
National Proton Conference highlights phase III trial data
By
AuntMinnie.com staff writers
Data supports survival benefit for intensity-modulated proton therapy (IMPT) in head and neck cancer.
April 10, 2026
MRI accident investigation continues, lawsuit filed
By
AuntMinnie.com staff writers
Next episode of "The Invisible Force" podcast coming soon.
April 10, 2026
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
Shine receives $263M conditional loan for Mo-99 isotope facility
By
AuntMinnie.com staff writers
Shine has received a conditional loan from the U.S. DOE to complete the Chrysalis medical isotope production facility for Mo-99.
April 9, 2026
Hyperfine wins CE Mark, UKCA approval for next-gen Swoop portable MRI
By
AuntMinnie.com staff writers
Hyperfine has received CE Marking and UKCA approval for its Swoop portable brain MRI system and its Optive AI software.
April 9, 2026
GEHC, Medtronic link bkActiv ultrasound system to Stealth AXiS
By
AuntMinnie.com staff writers
GE HealthCare and Medtronic will combine their respective ultrasound and surgical navigation systems for cranial procedures.
April 9, 2026
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