Regulatory: Page 32

FDA releases final guidance for special 510(k) process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a final guidance on its Special 510(k) program.
September 11, 2019
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Eon to offer free CMS lung screening compliance audits
By AuntMinnie.com staff writers
Patient management technology firm Eon is offering free U.S. Centers for Medicare and Medicaid Services (CMS) compliance audits to qualifying lung cancer screening programs.
September 4, 2019
2017 02 01 16 41 06 305 Lungs Smoke 400
How to get feedback on your MIPS performance
By Erin Stephens
The U.S. Centers for Medicare and Medicaid Services has announced that clinicians who participated in the Merit-Based Incentive Payment System (MIPS) in 2018 can access their 2018 performance feedback by logging in to the Quality Payment Program website. Erin Stephens of Healthcare Administrative Partners analyzes what this means for imaging providers.
August 29, 2019
2019 08 29 18 18 5039 Quality Check Mark 400
FDA adds transducer check to ultrasound guidance
By Kate Madden Yee
New ultrasound transducers should include an integrated quality control check that runs every time the probe is turned on, according to final guidance issued by the U.S. Food and Drug Administration (FDA) on August 22.
August 21, 2019
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USPSTF calls for more BRCA1/2 genetic screening, testing
By Emily Hayes
Broader recommendations on screening for BRCA1/2 genetic mutations published by the U.S. Preventive Services Task Force (USPSTF) on August 20 represent a vote of confidence for more testing, which has been widely viewed as underused.
August 20, 2019
2019 05 10 17 42 3167 Lab Doctors Dna 400
First look at new Medicare rules for 2020
By Sandy Coffta
The U.S. Centers for Medicare and Medicaid Services (CMS) has released its annual proposal for changes to the Medicare payment system for the coming year, explains Sandy Coffta from Healthcare Administrative Partners. CMS has also released new information about the existing mandate for the use of clinical decision support beginning in 2020.
August 19, 2019
2016 08 26 14 48 59 689 Calculator Pen 400
Trump administration hits brakes on law to curb unneeded Medicare CT scans, MRIs
By Phil Galewitz
The U.S. Congress passed a law in 2014 to reduce unnecessary MRI exams, CT scans, and other expensive diagnostic imaging tests, but the Trump administration delayed putting the law into effect until 2020 after physicians argued it would interfere with their practices. Critics worry the delay comes at a cost: Medicare paying for millions of unnecessary exams and patients subject to unnecessary radiation.
August 18, 2019
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USPSTF opens review of carotid stenosis screening
By Kate Madden Yee
The U.S. Preventive Services Task Force (USPSTF) has posted a draft research plan on screening for asymptomatic carotid artery stenosis, an exam that typically involves the use of ultrasound to detect signs of stenosis before a stroke can occur.
August 15, 2019
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NRC proposes changes to rules on radiotracer patients
By Wayne Forrest
The U.S. Nuclear Regulatory Commission (NRC) is proposing several updates in its regulatory guide on how best to handle patients who receive radioactive materials as part of their imaging scans.
August 14, 2019
2018 12 11 00 02 7009 Atom Nuclear Lab 400
Lunit wins Korean approval for breast cancer AI software
By AuntMinnie.com staff writers
Artificial intelligence (AI) image analysis software developer Lunit has received approval from the Korean Ministry of Food and Drug Safety for its Insight for mammography software.
August 11, 2019
FDA updates PAD vascular balloon, stent warning
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has updated a warning it issued earlier this year about the use of certain drug-containing balloons and stents in patients with peripheral arterial disease (PAD).
August 7, 2019
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ASRT backs reimbursement bill for radiopharmaceuticals
By AuntMinnie.com staff writers
The American Society of Radiologic Technologists (ASRT) released a statement of support for a bill that would loosen the bundling practices of diagnostic radiopharmaceuticals for Medicare billing.
July 31, 2019
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