Regulatory: Page 42

Report: Trump tariffs to focus on high-tech gear
By AuntMinnie.com staff writers
The Trump administration is expected to publish an updated list of products manufactured in China that will be subject to 25% import tariffs, and the list is expected to focus on high-tech equipment, according to a June 14 report from Bloomberg.
June 13, 2018
2018 06 14 22 43 9558 Chinese Flag 400
Mo. passes breast tomosynthesis coverage bill
By AuntMinnie.com staff writers
Before his May 29 resignation, Missouri Gov. Eric Greitens signed a bill into law that requires the state's insurers to provide benefits and coverage for both 2D mammography and 3D digital breast tomosynthesis, according to the American College of Radiology.
June 11, 2018
ACR responds to USPSTF CT lung screening research plan
By AuntMinnie.com staff writers
The American College of Radiology (ACR) and various partner associations have submitted a letter to the U.S. Preventive Services Task Force (USPSTF) offering recommendations for its upcoming five-year review of CT lung cancer screening.
June 10, 2018
2018 05 11 23 08 7758 No Smoking Sign 400
FDA issues medical device submission guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance regarding medical device submissions.
June 7, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
CMS again declines coverage for NaF-PET scans
By Wayne Forrest
Despite numerous studies and years of research into the benefits of PET imaging with sodium fluoride (NaF) for cancer patients with bone metastases, the U.S. Centers for Medicare and Medicaid Services (CMS) has again rejected reimbursement coverage.
June 6, 2018
2016 12 15 15 35 35 253 No Check Vote 400
NIH releases data science strategic plan
By AuntMinnie.com staff writers
The U.S. National Institutes of Health (NIH) has published its first Strategic Plan for Data Science and announced plans to hire a chief data strategist.
June 5, 2018
Vt. passes expanded breast screening coverage bill
By AuntMinnie.com staff writers
Vermont Gov. Phil Scott on May 21 signed into law HB 639, a bill that requires insurers in that state to cover additional breast imaging services without enforcing cost-sharing requirements.
June 4, 2018
FDA moves to reclassify CAD software to class II
By Wayne Forrest
Developers of image analysis software such as computer-aided detection (CAD) algorithms may soon have an easier regulatory path to market thanks to changes announced on Friday by the U.S. Food and Drug Administration (FDA), which wants to move the products from the more-stringent class III category to class II.
May 31, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
FDA reinstates NC mammography facility's accreditation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has reinstated the accreditation of a North Carolina mammography facility.
May 24, 2018
FDA adds 8 gadolinium MRI agents to medication guide
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) is continuing to update its information for patients, clinicians, and other healthcare practitioners regarding gadolinium-based contrast agents (GBCAs) by adding eight GBCA products to its medication guide.
May 17, 2018
2016 10 04 14 10 28 621 Gadolinium 400
MITA hails FDA quality report, seeks legislative action
By Erik L. Ridley
The Medical Imaging and Technology Alliance (MITA) said it strongly supports a new initiative by the U.S. Food and Drug Administration (FDA) to promote the adoption of quality management principles in equipment servicing; however, the group is also calling on Congress to take legislative action to protect patient safety.
May 15, 2018
2017 05 04 10 02 04 942 Capitol Hill2 400
FDA hits RadLogics with warning letter
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) sent a warning letter to data analysis software developer RadLogics for claims the company has made for its AlphaPoint software.
May 13, 2018
2016 09 02 09 36 05 93 Fda Logo V2 400
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