Regulatory

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
Fda Sign Dc 400 (1)
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
Ad Mri
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
Fda Sign Dc
FDA cites MRI study in new requirements for COVID-19 manufacturers
By Amerigo Allegretto
Cardiac MRI exams played a part in the U.S. FDA's requirements recently issued on COVID-19 vaccines and heart inflammation.
June 26, 2025
Covid 19 Vaccine Administer 400
FDA approves expanded uses for GE Healthcare’s Vizamyl
By AuntMinnie.com staff writers
The U.S. FDA has approved expanded indications for GE HealthCare’s Vizamyl PET imaging agent for beta-amyloid detection.
June 24, 2025
Brain Amyloid Plaque Neuron
Bayer submits gadoquatrane NDA
By AuntMinnie.com staff writers
Bayer has filed a New Drug Application (NDA) requesting U.S. FDA approval of its gadolinium-based contrast agent gadoquatrane.
June 20, 2025
Bayer Rsna 2019 67816294a00e6
FDA issues final order reclassifying radiological CAD software
By Liz Carey
Computer-assisted detection (CAD) and diagnosis algorithms used in radiology move from the class III to the class II category.
June 13, 2025
Fda Logo V2 400
FDA expands Polarean's Xe contrast agent use to younger children
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has expanded use of Polarean's Xenoview to include children starting at age 6.
June 2, 2025
Mri Scanner2 Social 667451decf13c
United Imaging gets FDA clearance for interventional x-ray system
By AuntMinnie.com staff writers
United Imaging has received clearance from the U.S. FDA for its uAngio Aviva interventional x-ray system.
May 14, 2025
United Imaging Rsna 2019 400
FDA approves GE HealthCare's Optison for pediatric use
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved GE HealthCare’s Optison ultrasound enhancing agent for pediatric use.
May 13, 2025
Ultrasound Child
FDA rejects NDA for Telix’s Pixclara
By AuntMinnie.com staff writers
The FDA has ruled that Telix's New Drug Application (NDA) for TLX101-CDx (Pixclara) cannot be approved in its current form.
April 29, 2025
Glioma Letters Brain
Health data restrictions plague medtech AI developers
By Liz Carey
Medtech industry and health leaders from big tech have introduced a new AI Policy Roadmap.
April 23, 2025
Data Protection Nijat
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