Regulatory

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
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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
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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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Xeris secures FDA approval for Gvoke VialDx for x-ray exams
By AuntMinnie.com staff writers
Biopharma firm Xeris has received FDA approval for its Gvoke VialDx to be used as a diagnostic aid for abdominal x-ray exams.
March 18, 2025
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ACR cautions in light of regulatory break on ownership reporting
By AuntMinnie.com staff writers
The U.S. Department of Treasury will not enforce the Corporate Transparency Act come March 21, but the underlying law remains in effect.
March 14, 2025
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ACR spotlights 2025 scope of practice bills
By AuntMinnie.com staff writers
Legislators in numerous U.S. states will be considering scope of practice bills in 2025, according to the ACR's government relations team.
February 21, 2025
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