Regulatory: Page 3

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

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

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

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

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

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

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

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

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

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

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

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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