Regulatory: Page 29

FDA offers guidance on angioplasty and specialty catheters
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for premarket submission applications of peripheral percutaneous transluminal angioplasty and specialty catheters.
January 9, 2020
DOE waives export ban on highly enriched uranium
By AuntMinnie.com staff writers
The U.S. Department of Energy (DOE) is moving to allow the export of weapons-grade uranium, the same substance used to manufacture medical isotopes, such as molybdenum-99.
January 8, 2020
2019 11 22 00 29 1365 Molybdenum Element 400
Raleigh Radiology faces lawsuit over mammo services
By AuntMinnie.com staff writers
Raleigh Radiology is now facing a lawsuit related to the suspension of its mammography services last month by the American College of Radiology and the U.S. Food and Drug Administration.
January 7, 2020
2016 12 21 15 58 26 460 Scales Of Justice 400
Calif. center stops mammography screening
By AuntMinnie.com staff writers
An imaging facility in Southern California had its accreditation revoked earlier this year and is no longer performing mammography after an audit revealed that 21 of the site's 30 breast screening cases did not meet image quality standards.
December 19, 2019
2019 10 07 17 39 4512 Warning Circular 400
MITA lauds Congress for supporting device tax repeal
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) is applauding lawmakers in the U.S. Congress for their bipartisan support of a permanent repeal of the medical device tax in their proposed year-end government funding package.
December 17, 2019
2019 12 17 23 59 6699 News Ball 400
Mammo services halted at NC facility
By AuntMinnie.com staff writers
Mammography services have been suspended at Raleigh Radiology Blue Ridge after a review of its services by the American College of Radiology and the U.S. Food and Drug Administration.
December 17, 2019
2017 03 30 15 16 56 745 Mammogram Calendar 400
Elekta gets FDA nod for DWI-MR radiation therapy
By AuntMinnie.com staff writers
Radiation oncology vendor Elekta has received 510(k) premarket notification from the U.S. Food and Drug Administration (FDA) for the clinical use of a diffusion-weighted imaging (DWI) MRI protocol with the company's Unity MR radiation therapy system.
December 15, 2019
2019 09 17 17 08 4562 Elekta Astro 2019
FDA moves to electronic-only device submissions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.
December 12, 2019
2016 09 02 09 36 05 93 Fda Logo V2 400
Senate confirms Hahn as FDA commissioner
By AuntMinnie.com staff writers
The U.S. Senate has confirmed the Trump administration's nomination of radiation oncologist Dr. Stephen Hahn as commissioner of the U.S. Food and Drug Administration (FDA).
December 12, 2019
2019 11 01 22 16 2253 Hahn Stephen 20191101221734
PET and prejudice: Insurance firms' misconceptions
By Wayne Forrest
Healthcare insurance companies should value PET imaging and its cost-effective contributions to patient outcomes rather than view the modality as too expensive and unworthy of reimbursement, according to an editorial in the December issue of the Journal of Nuclear Medicine.
December 9, 2019
2018 10 12 18 59 0501 Insurance Check 400
VA endorses AI research with new institute
By AuntMinnie.com staff writers
The U.S. Department of Veterans Affairs (VA) has set up a new institute, the National Artificial Intelligence Institute, dedicated to advancing artificial intelligence (AI) research that might be meaningful to veterans and the public.
December 8, 2019
2019 12 09 17 23 7420 Veterans Affairs Va Seal 400
FDA proposes change in MRI coil 510(k) submissions
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has proposed a revision to performance and safety information in 510(k) submissions for certain MRI coils.
December 5, 2019
2016 09 02 09 28 19 895 Fda Logo 400
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