Regulatory

FDA defines 'transparency' for AI medical devices
By Will Morton
The U.S. Food and Drug Administration (FDA) has sketched out details to help improve the transparency of AI software product information.
February 1, 2024
Question
MITA members find new home for imaging equipment advocacy efforts
By Erik L. Ridley
Key corporate members and staff from the Medical Imaging Technology Alliance (MITA) are launching a new medical imaging technology division at medical technology trade association Advanced Medical Technology Association (AdvaMed).
December 11, 2023
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NEA focuses on medical isotope supply chain
By AuntMinnie.com staff writers
Medical radioisotopes are supplied by an aging nuclear infrastructure that threatens the security and availability of critical isotopes.
December 6, 2023
Isotopes
Clarius lauds Fla. bill on ultrasound guidance for plastic surgery
By AuntMinnie.com staff writers
Clarius Mobile Health is applauding the passing of a Florida bill that mandates ultrasound guidance during gluteal fat grafting procedures by plastic surgeons.
July 19, 2023
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MITA unveils educational video on OEMs, ISOs
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) has launched a new educational video that addresses differences in training requirements between original equipment manufacturers (OEMs) and independent service organizations (ISOs).
July 17, 2023
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Week in Review: Radiology payment cuts | AI spots diabetes on chest x-rays | SalaryScan
By Erik L. Ridley
July 14, 2023
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
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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
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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
2021 11 20 00 07 5698 Amyloid Plaque Alzheimer2 400
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
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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
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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
2019 06 27 17 42 3952 Business Man Handshake 400
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