Regulatory

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
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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
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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
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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
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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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DESKi granted FDA clearance for cardiac AI software
By AuntMinnie.com staff writers
The U.S. FDA has granted 510(k) clearance to DESKi for its HeartFocus AI-enabled cardiac exam software.
April 15, 2025
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Senators introduce medical AI reimbursement bill
By Amerigo Allegretto
A bill introduced in the U.S. Congress aims to establish a reimbursement pathway for FDA-authorized medical devices that rely on AI.
April 10, 2025
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Brainomix stroke software granted FDA clearance
By AuntMinnie.com staff writers
The U.S. FDA has granted 510(k) clearance to Brainomix for a feature of its 360 Stroke software.
April 8, 2025
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FDA greenlights Telix NDA for prostate imaging agent Gozellix
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Telix's TLX007-CDx for prostate cancer imaging.
March 21, 2025
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