Regulatory: Page 36

Gottlieb steps down as FDA commissioner
By Erik L. Ridley
U.S. Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb is resigning and will be leaving the agency over the next month, according to multiple published reports.
March 4, 2019
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FDA issues stern thermography warning
By Kate Madden Yee
Thermography should not be used as a standalone method for detecting, diagnosing, or screening for breast cancer, according to a warning issued by the U.S. Food and Drug Administration (FDA) on February 25.
February 24, 2019
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DOE to fund U.S. Mo-99 production
By AuntMinnie.com staff writers
The U.S. Department of Energy's (DOE) National Nuclear Security Administration has set the stage to begin negotiations with four companies to produce molybdenum-99 (Mo-99) in the U.S.
February 20, 2019
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ACR sounds alarm regarding Medicare ultrasound cuts
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is urging radiologists to help it block $112 million in Medicare ultrasound reimbursement cuts by sending invoices to the college that reflect the actual cost of ultrasound equipment.
February 19, 2019
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New federal law requires language on breast density
By AuntMinnie.com staff writers
U.S. mammography providers must now include language about breast density in mammography reports delivered to patients and physicians as part of legislation passed last week, according to breast density education group DenseBreast-info.org.
February 18, 2019
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More states seek to expand mammography, DBT coverage
By AuntMinnie.com staff writers
A number of U.S. states have pending legislation that would expand access to and coverage of mammography and digital breast tomosynthesis (DBT) screening, according to the American College of Radiology.
February 18, 2019
ONC proposes rules to improve data interoperability
By AuntMinnie.com staff writers
The U.S. government is proposing new rules to give patients easier access to their own medical data through devices such as smartphones. The U.S. Office of the National Coordinator for Health Information Technology (ONC) hopes the rules will improve data interoperability and empower patients to take more control over their care.
February 13, 2019
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Axonics files with FDA for full-body MRI labeling
By AuntMinnie.com staff writers
Axonics Modulation Technologies has submitted an application to the U.S. Food and Drug Administration (FDA) to enable the company to add full-body MRI-conditional status to the regulatory labeling of its Axonics r-SNM sacral neuromodulation implants.
February 12, 2019
FDA offers update on breast implant-related lymphoma
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) on February 6 issued an update on the agency's efforts to track breast implant-associated anaplastic large cell lymphoma, a type of non-Hodgkin's lymphoma that is a known risk of breast implants.
February 6, 2019
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FDA updates adverse event report for NY mammo facility
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has updated an adverse event report it issued for South Shore Radiology of Howard Beach, NY.
February 4, 2019
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Centerline submits 510(k) for navigation system
By AuntMinnie.com staff writers
Centerline Biomedical has submitted a 510(k) application with the U.S. Food and Drug Administration for its Intra-Operative Positioning System (IOPS), which the company sees as a potential alternative to fluoroscopy for intraoperative navigation.
January 29, 2019
Deadline nears for NRC limited user feedback
By AuntMinnie.com staff writers
The January 29 deadline is fast approaching to submit comments on the Nuclear Regulatory Commission's (NRC) consideration of establishing training and experience criteria for becoming a limited user of radiopharmaceuticals.
January 24, 2019
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