Regulatory: Page 19

KA lands Health Canada license for Sight detector
By AuntMinnie.com staff writers
Digital x-ray manufacturer KA Imaging has garnered a medical device license from Health Canada for its Sight flat-panel detector.
April 12, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
Nines wins FDA clearance for AI lung nodule measurement
By AuntMinnie.com staff writers
Teleradiology services provider Nines has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for NinesMeasure, a semiautomatic artificial intelligence (AI)-based application for measuring lung nodules on chest CT exams.
March 29, 2021
2021 03 30 21 34 2257 Artificial Intelligence Ai 400
FDA issues mammography alert for Tenn. facility
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) said it's alerting patients who received mammograms at Tennessee Women's Care in Nashville, TN, on or after November 1, 2019, that there may be possible problems with the quality of their mammograms.
March 29, 2021
2016 09 02 09 36 05 93 Fda Logo V2 400
Imbio nets FDA nod for RV/LV Analysis AI algorithm
By AuntMinnie.com staff writers
Artificial intelligence (AI) software developer Imbio has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for RV/LV Analysis, a cardiothoracic imaging AI algorithm.
March 15, 2021
2020 02 24 17 44 7728 Clearance Stamp 400
FDA gives 510(k) clearance ControlRad Select
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to medical device company ControlRad for the marketing of its ControlRad Select radiation dose-reduction technology.
March 2, 2021
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CMS ends noncoverage of PET infection and inflammation
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has ended its longstanding national noncoverage policy for PET imaging for infection and inflammation, according to the Society of Nuclear Medicine and Molecular Imaging.
March 2, 2021
2018 05 22 18 57 9927 Snmmi Logo 400
Probe finds fault with patient notification at Washington, DC, VA
By AuntMinnie.com staff writers
A U.S. government investigation has found deficiencies in the way patients were notified about their mammography results after receiving breast screening at the Washington, DC, Veterans Affairs (VA) Medical Center.
February 25, 2021
2019 12 09 17 23 7420 Veterans Affairs Va Seal 400
Akumin to pay $750K to settle fraud case
By AuntMinnie.com staff writers
Imaging center operator Akumin has agreed to pay $750,000 to the U.S. government to settle healthcare fraud charges regarding Medicare physician supervision requirements.
February 3, 2021
2020 02 20 18 12 3118 Money Bills 400
How will MPFS changes affect your radiology practice?
By Sandy Coffta
When the Medicare Physician Fee Schedule (MPFS) final rule was published in December, it looked like radiology was facing a significant cut in Medicare reimbursement for 2021. Sandy Coffta of Healthcare Administrative Partners takes a closer look.
January 26, 2021
2021 01 26 19 34 6212 Businessman Plan Graph 400
Texas mammography center gets certificate reinstated
By AuntMinnie.com staff writers
A hospital in Texas has resumed mammography screening services after having its accreditation revoked for failing to meet clinical standards for images.
January 21, 2021
2020 07 06 16 56 9392 Texas Flag 400
USPSTF readies update to breast screening guidelines
By Theresa Pablos
The U.S. Preventive Services Task Force (USPSTF) has published the draft research plan it will use to update its mammography screening guidance. The plan is the first step to issuing new USPSTF breast screening recommendations, which can affect how private insurers reimburse screening.
January 20, 2021
2019 02 19 18 03 9526 Mammogram Breast 400
SNMMI urges fast-track review of Technegas for V/Q scans
By Brian Casey
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to begin a fast-track review of the Technegas agent for nuclear medicine ventilation/perfusion (V/Q) lung scans.
January 20, 2021
2021 01 21 19 03 5869 Lung Illustration Blue 400
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