Regulatory

NQF seeks comments on 'high stakes' healthcare quality measurement
By AuntMinnie.com staff writers
Initiative may eventually inform broader applications beyond accountability programs.
September 26, 2025
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ACR CEO talks imaging’s role in spending bill
By Amerigo Allegretto
Dana Smetherman, MD, CEO of the ACR, spoke with AuntMinnie.com about appropriations bills and how imaging may be affected.
September 23, 2025
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HeartFlow secures 510(k) for next-gen algorithm
By AuntMinnie.com staff writers
Corresponding with the FDA clearance, the company also highlighted the unveiling of its DECIDE Registry.
September 23, 2025
Heart Glowing Red
RBMA sends commentary to CMS on MPFS Proposed Rule
By AuntMinnie.com staff writers
The RBMA has sent recommendations to the Centers for Medicare & Medicaid Services (CMS) on the 2026 MPFS Proposed Rule.
September 9, 2025
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Telix, FDA agree on NDA resubmission path for Pixclara
By AuntMinnie.com staff writers
Telix has reached an agreement with the U.S. FDA on a resubmission plan for its New Drug Application (NDA) for Pixclara.
September 9, 2025
Glioma Letters Brain
U.S. FDA clears 4DMedical's ventilation-perfusion CT:VQ imaging system
By AuntMinnie.com staff writers
CT:VQ converts standard, noncontrast chest CTs into quantitative, lobar ventilation, and perfusion maps.
September 5, 2025
Ct Scanner 6563edb5e443e
FDA rejects Telix's BLA for kidney cancer investigational PET agent
By AuntMinnie.com staff writers
The U.S. FDA has requested additional data from Telix for its biologics license application (BLA) regarding its TLX250-CDx PET agent.
August 29, 2025
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N.C. legislators address imaging, radiation therapy licensing
By AuntMinnie.com staff writers
North Carolina is one of only five states with no standards or licensing structure for medical imaging or radiation therapy.
July 24, 2025
Law Books
RadSite launches remote scanning accreditation program
By AuntMinnie.com staff writers
Rapid expansion of teleradiology and mobile imaging platforms prompt new accreditation pathway.
July 22, 2025
Accreditation Maze
Radiology drives July FDA AI-enabled medical device update
By Liz Carey
The U.S. FDA has just publicly listed 211 AI-enabled medical devices that have received regulatory clearances
July 14, 2025
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FDA approves updated label for Lilly's Kisunla
By AuntMinnie.com staff writers
The label update is expected to reduce the incidence of ARIA-E.
July 9, 2025
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FDA clears Insightec's ultrasound treatment for Parkinson’s
By AuntMinnie.com staff writers
The U.S. FDA has cleared Insightec's focused ultrasound treatment for patients with advanced Parkinson's disease.
July 8, 2025
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