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Regulatory: Page 2
CMS proposes radiology reimbursement cuts, AUC pause for 2024 MPFS
By
Erik L. Ridley
In what has seemingly become an annual event, the U.S. Centers for Medicare and Medicaid Services (CMS) has once again included radiology reimbursement cuts in its Medicare Physician Fee Schedule (MPFS) Proposed Rule.
July 13, 2023
FDA: Paclitaxel-coated devices unlikely to increase mortality
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration has sent a letter to healthcare providers stating that use of paclitaxel-coated devices such as balloons and stents in patients with peripheral arterial disease (PAD) is unlikely to increase risk of mortality.
July 10, 2023
SNMMI calls for clarity over Leqembi PET scans
By
AuntMinnie.com staff writers
The Society of Nuclear Medicine and Molecular Imagine (SNMMI) has called for clarity over whether amyloid PET scans will be covered for potential candidates for the new Alzheimer's disease drug Leqembi (lecanemab).
July 10, 2023
Marketing, regulatory summaries may differ with AI tech
By
Amerigo Allegretto
Inconsistencies between marketing and regulatory clearance exist in over one in six radiology machine-learning and AI technologies, suggest findings published July 5 in
JAMA Network Open
.
July 5, 2023
FTC mulls changes to company merger rules
By
AuntMinnie.com staff writers
The Federal Trade Commission (FTC) recently issued a notice of proposed rulemaking in collaboration with the Department of Justice's Antitrust Division that may make company mergers more difficult to execute.
June 28, 2023
RLS appoints new director of regulatory affairs
By
AuntMinnie.com staff writers
Radioisotope Life Sciences (RLS), a U.S.-based nuclear pharmacy network, recently appointed Glenn Sullivan, PhD, as the company's director of regulatory affairs.
June 13, 2023
How you can help improve the Medicare Physician Fee Schedule
By
Sandy Coffta
In a new column, Sandy Coffta of Healthcare Administrative Partners shares how radiologists can play their part in lobbying Congress to improve the Medicare Physician Fee Schedule.
June 12, 2023
DeepTek.ai nets FDA nod for workflow software
By
AuntMinnie.com staff writers
Radiology AI software developer DeepTek.ai of Maharashtra, India, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Augmento AI-powered radiology workflow management software.
June 8, 2023
CMS to cover Alzheimer's drugs for patients enrolled in registry
By
AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will cover newly approved Alzheimer's disease drugs for people enrolled in a national patient registry, according to a June 1 news release.
May 31, 2023
FDA clears GE HealthCare's deep learning-based image processing software
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared GE HealthCare's Precision DL deep learning-based image processing software.
May 29, 2023
FDA accepts Lumicell breast cancer optical imaging agent NDA
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has accepted for review Lumicell's new drug application for its Lumisight optical imaging agent for breast cancer and a premarket approval application for the company's direct visualization system.
May 21, 2023
Neurophet receives FDA clearance for Aqua
By
AuntMinnie.com staff writers
Artificial intelligence software developer Neurophet has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aqua brain MRI analysis software.
May 17, 2023
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