Regulatory: Page 46

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance regarding medical device submissions.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
InSightec submits PMA to Japan for Exablate device
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the Japanese Pharmaceuticals and Medical Devices Agency for its Exablate Neuro (Exablate 4000) device.
May 13, 2018
CFDA drafts guidance on 3D-printed medical devices
By AuntMinnie.com staff writers
The China Food and Drug Administration (CFDA) has released a draft guidance covering the regulation of customized 3D-printed medical devices.
May 10, 2018
2016 10 18 16 55 18 858 Chinese Flag Button 400
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