Regulatory: Page 37

Breast density group asks FDA to clarify notification
By Kate Madden Yee
Efforts by the U.S. Food and Drug Administration (FDA) to standardize breast density notification across the U.S. are admirable but could be improved, according to comments submitted to the FDA June 12 by advocacy group DenseBreast-info.org.
June 13, 2019
2016 10 03 11 12 26 718 Checklist 400
ASTRO commends new prior authorization legislation
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) is lauding bipartisan federal legislation that would curb restrictive prior authorization practices that delay patient access to critical cancer treatments.
June 6, 2019
NRC offers options for radiopharmaceutical training
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) has proposed four options relative to current requirements to administer radiopharmaceuticals, including reducing the number of training and experience hours from 700 to 400.
June 3, 2019
2018 12 11 00 02 7009 Atom Nuclear Lab 400
ACR lauds bipartisan bill on 'surprise' medical charges
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is lauding the U.S. House of Representatives for the introduction of bipartisan legislation that addresses "surprise" medical bills.
May 22, 2019
2016 10 14 12 22 19 364 Acr Logo 400
RefleXion files 510(k), opens manufacturing facility
By AuntMinnie.com staff writers
Radiation therapy equipment developer RefleXion Medical has filed a 510(k) application with the U.S. Food and Drug Administration for its biology-guided radiotherapy system. The firm also opened a new 50,000-sq-ft manufacturing facility in Hayward, CA.
May 22, 2019
2019 05 23 15 24 6544 Reflexion Hq 2019
Senate gets bill for RA Medicare payments
By AuntMinnie.com staff writers
U.S. Sen. John Boozman (R-AR) has introduced the Senate's version of the Medicare Access to Radiology Care Act, a bill that would allow radiologists to submit Medicare claims for nonimaging services performed by radiologist assistants (RAs).
May 21, 2019
NRC taking feedback on radiopharma user rules
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) has commenced a 30-day comment period and has scheduled two public meetings on its proposal to revise training and experience requirements for administering radiopharmaceuticals.
May 7, 2019
2018 12 11 00 02 7009 Atom Nuclear Lab 400
FDA issues 2 more guidances on x-ray devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued two final guidances that outline regulatory requirements for x-ray imaging.
May 6, 2019
2016 09 02 09 28 19 895 Fda Logo 400
Ga. adopts dense breast notification law
By AuntMinnie.com staff writers
Georgia has become the 38th state in the U.S. to mandate that women be notified of their dense breast condition and the associated risks.
May 6, 2019
Tenn. imaging group hit with $3M fine for data breach
By AuntMinnie.com staff writers
Imaging services provider Touchstone Medical Imaging of Franklin, TN, will pay $3 million to settle potential HIPAA violations from a data breach that exposed protected health information online for more than 300,000 patients, according to the U.S. Department of Health and Human Services Office for Civil Rights.
May 6, 2019
2019 05 06 22 40 2229 Cybersecurity Locks 400
ACR to bring agenda to Capitol Hill Advocacy Day May 22
By AuntMinnie.com staff writers
More than 400 members of the American College of Radiology (ACR) will visit their elected government representatives May 22 on the college's Capitol Hill Advocacy Day at its 2019 annual meeting.
May 5, 2019
2017 05 04 10 02 04 942 Capitol Hill2 400
Radiation events prompt FDA notice on Rb-82 generators
By Wayne Forrest
The U.S. Food and Drug Administration (FDA) has bolstered its requirement for safety labels on rubidium-82 (Rb-82) generators for PET studies. The action follows reports of a "serious incident" of excess radiation exposure to patients caused by what the FDA called "user error."
April 30, 2019
2016 08 30 09 29 44 134 Radiation Symbol Circle 400
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