Regulatory

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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GE HealthCare secures 510(k) for updated Voluson Expert ultrasound
By AuntMinnie.com staff writers
Enhancements support AI in women's imaging, particularly in complex, high-risk pregnancies.
January 28, 2025
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Median Technologies extends cash runway by $50M
By AuntMinnie.com staff writers
The company's lung cancer screening software as a medical device is on track for U.S. FDA regulatory approval in Q2.
January 24, 2025
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FDA issues guidance on scanning interference with implanted medical devices
By AuntMinnie.com staff writers
The FDA has received some reports of electronic medical devices being damaged during CT scans.
October 25, 2024
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Telix files for Nasdaq listing, posts Q3 update
By AuntMinnie.com staff writers
Telix Pharmaceuticals has filed with the U.S. Securities and Exchange Commission to list its ordinary shares and trade on the Nasdaq exchange.
October 18, 2024
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RSNA offers clinical trials methodology workshop
By AuntMinnie.com staff writers
The RSNA will hold a free, six-day clinical trials methodology workshop in January 2025.
October 15, 2024
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