Regulatory: Page 9

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
Provider relief fund reporting extensions are available
By Rebecca Farrington
Is your radiology practice looking for an extension on the reporting requirements involved in receiving grants under the U.S. government's Provider Relief Funds program? If so, Rebecca Farrington of Healthcare Administrative Partners offers some guidance.
April 25, 2022
2020 07 31 22 16 0362 Dollar Money Coronavirus Mask 400
FDA patient committee to discuss virtual reality technology
By AuntMinnie.com staff writers
A committee of the U.S. Food and Drug Administration (FDA) that represents the interests of patients plans to meet in July to discuss medical devices that use augmented reality and virtual reality.
April 12, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
FDA says AI doesn't exclude LVO cases from radiologist review
By Brian Casey
Artificial intelligence (AI) software shouldn't be used to rule out cases of intracranial large-vessel occlusion (LVO) from radiologist review, according to an advisory issued April 11 by the U.S. Food and Drug Administration.
April 10, 2022
2019 11 22 20 38 5687 Computer Brain Ai 400
CMS criticized for final decision on Aduhelm reimbursement
By Will Morton
The U.S. Centers for Medicare and Medicaid Services (CMS) finalized a plan April 7 that limits coverage of Biogen's Alzheimer's disease drug Aduhelm only to patients enrolled in clinical trials, despite pressure from the Society of Nuclear Medicine and Molecular Imaging and other groups to expand coverage of the drug.
April 7, 2022
2017 05 04 10 02 04 942 Capitol Hill2 400
CMS finalizes rule on limited payment for Alzheimer's drugs
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final national coverage determination that limits coverage for Alzheimer's monoclonal antibody drugs like aducanumab only to people enrolled in qualifying clinical trials.
April 6, 2022
2020 06 15 23 55 8696 Patient Elderly Woman 400
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