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Regulatory
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
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 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
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
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
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 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
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
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
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
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
Cortechs.ai software gets Health Canada approval
By
AuntMinnie.com staff writers
AI developer Cortechs.ai has received approval from Health Canada for its medical imaging analysis software suite.
April 22, 2025
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