Regulatory: Page 12

Biden creates new cancer care model for Medicare patients
By AuntMinnie.com staff writers
The Biden administration has announced the Enhancing Oncology Model (EOM), a new model to improve cancer care among Medicare patients and address health equity.
June 26, 2022
2020 02 27 23 28 4046 Doctor Cancer Patient 400
CMS rethinks limit on PET scans for Alzheimer’s disease patients
By Will Morton
The U.S. Centers for Medicare and Medicaid Services (CMS) will take another look at its recent national coverage determination that limits Alzheimer’s disease patients eligible for monoclonal antibody treatments to a single PET scan.
June 26, 2022
2017 05 04 10 02 04 942 Capitol Hill2 400
U.S. report on COVID response says Atlas strategy caused deaths
By Brian Casey
A new report issued by a U.S. House of Representatives subcommittee on the Trump administration's response to the COVID-19 pandemic blames controversial neuroradiologist Dr. Scott Atlas for a strategy that led to thousands of "preventable" deaths from the SARS-CoV-2 virus.
June 21, 2022
2020 07 01 22 14 2802 Washington Dc Capitol 400
FDA finalizes quantitative imaging guidance
By AuntMinnie.com staff writers
Three years after the draft guidance was published, the U.S. Food and Drug Administration (FDA) has published its final guidance for manufacturers planning to submit radiological devices with quantitative imaging functionality for premarket review.
June 14, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
Biden signs MAMMO Act to improve breast imaging for veterans
By Brian Casey
President Joe Biden on June 7 signed the Making Advances in Mammography and Medical Options for Veterans Act (the MAMMO Act), legislation that would improve breast imaging services for military veterans.
June 6, 2022
2022 06 07 22 45 7400 Patient Woman Veteran Wheelchair 400
Stryker nets FDA clearance for Q Guidance
By AuntMinnie.com staff writers
Orthopedic device developer Stryker has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance spine surgery navigation software.
May 30, 2022
2020 02 24 17 44 7728 Clearance Stamp 400
Telix gets pass-through status for Illuccix
By AuntMinnie.com staff writers
Telix Pharmaceuticals has received transitional pass-through payment status from the U.S. Centers for Medicare and Medicaid Services for its Illuccix prostate-specific membrane antigen PET radiopharmaceutical.
May 30, 2022
2019 04 17 20 48 2514 Prostate 3 D 400
FDA urges risk management plans for drug shortages
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) is calling on drug manufacturers to develop risk management plans to handle drug shortages.
May 19, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
ACR hails request to hold surprise billing appeal
By AuntMinnie.com staff writers
The American College of Radiology (ACR) and two other medical associations are pleased with the U.S. government’s decision to “hold” on its appeal of a federal court ruling in Texas on the interim final rule (IFR) for the No Surprises Act.
May 5, 2022
2016 10 14 12 22 19 364 Acr Logo 400
FDA grants approval for diagnostic test for Alzheimer's plaques
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has granted clearance for an vitro diagnostic test that could compete with PET for assessing whether individuals have amyloid plaque buildup associated with Alzheimer's disease.
May 5, 2022
2022 05 06 16 35 7835 Computer Brain Hemisphere 20220506164617
AUC penalty phase set to begin
By Sandy Coffta
Will the U.S. government's requirement to use clinical decision support (CDS) to order advanced imaging scans finally become a reality? Sandy Coffta of Healthcare Administrative Partners ponders this question.
May 5, 2022
2016 10 03 11 12 26 718 Checklist 400
Franklin Mountain gets FDA nod for dual-lumen catheter
By AuntMinnie.com staff writers
Interventional cardiology technology developer Franklin Mountain Medical has secured U.S. Food and Drug Administration (FDA) clearance for its UltraNav transseptal dual-lumen catheter.
April 25, 2022
2019 03 25 23 23 9633 Heart Yellow 400
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