Regulatory: Page 31

Most lung vaping cases linked to informal sources of THC
By Melissa Busch
The recent outbreak of lung disease linked to vaping appears to be most prevalent in people who vaped THC-containing products obtained from informal sources, such as family, dealers, and online, according to a new report released on January 14 by the U.S. Centers for Disease Control and Prevention.
January 16, 2020
2019 08 20 18 44 6604 Vaping E Cigarette Man 400
Carestream wins FDA clearance for tomosynthesis
By AuntMinnie.com staff writers
Carestream Health has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its digital tomosynthesis software, adding a 3D capability to the firm's general radiography technology.
January 13, 2020
2020 01 14 18 18 4944 Carestream Dt 20200114183606
Aidoc secures FDA clearance for AI stroke software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Israeli artificial intelligence (AI) software developer Aidoc's AI software for identifying large-vessel occlusion stroke on head CT angiography scans.
January 12, 2020
2020 01 13 17 52 0598 Artificial Intelligence Ai Brain 400
FDA clears patient-specific 3D-printed airway stent
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared patient-specific 3D-printed airway stents designed from CT scans by a physician from the Cleveland Clinic.
January 12, 2020
2020 01 13 17 38 0908 Cleveland Clinic Stent 400 Thumb
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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for premarket submission applications of peripheral percutaneous transluminal angioplasty and specialty catheters.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
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