Regulatory

FDA issues discussion paper on GenAI medical devices
By AuntMinnie.com staff writers
The paper covers risk assessment, pre-market evaluation, and considerations around foundation models and agentic AI systems.
August 18, 2026
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Lantheus wins FDA approval for tau PET imaging agent
By AuntMinnie.com staff writers
Tauklarify, previously known as MK-6240, has been approved for tau PET imaging in adults with cognitive impairment being evaluated for Alzheimer's disease.
August 14, 2026
Approved Stamp 400
Petition asks FDA to implement new OEM rule for MRI safety
By Liz Carey
Radiofrequency (RF)-induced burns prompt recommendations to MRI manufacturers.
July 14, 2026
Mri Scanner2 Social
RadioMedix wins FDA ANDA approval for Ga-68 PSMA-11 PET imaging agent
By AuntMinnie.com staff writers
Company highlights ANDA and FDA inspection.
June 10, 2026
Atom Nuclear Lab Thumb
Radiopharmaceutical manufacturers report uneven FDA inspections
By Liz Carey
RMTA lays out radiopharmaceutical regulatory and payment policy issues.
June 4, 2026
Lab Equipment Drug Manufacturing
MGMA endorses bill promising Medicare Advantage (MA) reform
By AuntMinnie.com staff writers
MA is becoming untenable for many practices, according to MGMA.
April 24, 2026
Washington Dc Capitol Social
CMS, FDA align with new breakthrough medical device coverage pathway
By AuntMinnie.com staff writers
CMS will pause Transitional Coverage for Emerging Technologies (TCET).
April 24, 2026
Policy Update Adobe Ai Design
FDA strikes down radiology AI 510(k) exemption arguments
By Liz Carey
Regulator rejects broad statement of user capabilities in detecting performance issues.
April 13, 2026
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FDA accepts Telix NDA for glioma PET agent Pixclara
By AuntMinnie.com staff writers
The NDA resubmission included additional data and statistical analysis requested by the U.S. FDA.
April 10, 2026
Pet Brain Scan Adobe Michael dim5r Awl G7
Bayer gets first approval for gadoquatrane in Japan
By AuntMinnie.com staff writers
Bayer received approval from Japan's Ministry of Health, Labour, and Welfare for its low-dose macrocyclic gadolinium-based contrast agent gadoquatrane.
March 24, 2026
Bayer
Telix resubmits NDA for Pixclara brain cancer PET imaging agent
By AuntMinnie.com staff writers
The New Drug Application (NDA) resubmission includes additional data and statistical analysis requested by the U.S. FDA.
March 17, 2026
Pet Brain Scan Adobe Michael
FDA moves to quickly replace adverse event reporters
By AuntMinnie.com staff writers
The U.S. FDA has launched a single platform for analyzing adverse event reports across all product categories the agency regulates.
March 11, 2026
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