Regulatory

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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MITA urges 'one stability, one facility' with PET drug inspections
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) has responded to the U.S. FDA's change in policy on radiopharmaceutical manufacturer inspections.
October 4, 2024
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FDA approves flurpiridaz F-18 PET tracer for imaging heart disease
By Will Morton
The U.S. Food and Drug Administration (FDA) approved the radiotracer flurpiridaz F-18 September 27 for PET imaging of coronary artery disease.
September 27, 2024
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ACR responds to Congressional query on AI reimbursement
By Liz Carey
ACR CEO William Thorwarth Jr., MD, issued a nine-page letter to Congress on how to solve the reimbursement problem for AI in healthcare.
May 9, 2024
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