Regulatory: Page 39

Groups urge mandated coverage for CT colonography
By AuntMinnie.com staff writers
Colorectal cancer care advocacy groups and physician organizations are calling on the U.S. Congress to approve a bill that would provide Medicare coverage for screening CT colonography.
September 19, 2018
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Senate opioid bill includes provision for ultrasound treatment
By AuntMinnie.com staff writers
In a 99-1 vote, the U.S. Senate on September 17 passed the Opioid Crisis Response Act of 2018. The bill includes a provision to support the development of ultrasound-guided technologies for pain management as an alternative to opioids.
September 18, 2018
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FDA restores Fla. mammography center's accreditation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has reinstated the mammography accreditation for a Florida radiology practice, Lakes Radiology II in Sunrise.
September 13, 2018
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FDA to work with tech on digital health innovation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) plans to work with the tech industry to spur innovation in digital health and facilitate the regulatory process, according to a statement it released on September 12.
September 12, 2018
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Health Canada approves Exact Imaging's FusionVu
By AuntMinnie.com staff writers
Health Canada has approved ultrasound technology developer Exact Imaging's FusionVu application for microultrasound/MRI fusion using the ExactVu high-resolution microultrasound system.
September 11, 2018
IRadimed MRI vital signs monitor gets cleared in Japan
By AuntMinnie.com staff writers
MRI accessories developer IRadimed said it received regulatory clearance from the Japanese Ministry of Health, Labor, and Welfare for its MRI-compatible patient vital signs monitor.
September 11, 2018
Calif. extends breast density law through 2025
By AuntMinnie.com staff writers
Gov. Jerry Brown of California has signed legislation to extend the state's breast density reporting law through January 1, 2025.
September 10, 2018
C-MIMI: FDA readies program to speed software reviews
By Kate Madden Yee
SAN FRANCISCO - The U.S. Food and Drug Administration (FDA) wants to make it easier for software developers to get regulatory clearance for their products with a new approach similar to the precertification program used for airline travelers, according to a presentation delivered at the Conference on Machine Intelligence in Medical Imaging (C-MIMI).
September 10, 2018
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Health Canada to draft guidance for medical 3D printing
By AuntMinnie.com staff writers
Health Canada is developing a guidance to facilitate the licensing of 3D-printed medical devices, according to a report from the U.S. Food and Drug Administration.
September 6, 2018
FDA launches pilot program to expedite 501(k) process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has launched its new Quality in 510(k) (Quik) Review pilot program to speed up the regulatory clearance of certain moderate-risk medical devices.
September 5, 2018
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VA radiologist wins White House fellowship
By AuntMinnie.com staff writers
The American College of Radiology said that Dr. Michelle Dorsey has become the first U.S. Department of Veterans Affairs (VA) physician to receive a White House leadership fellowship.
September 3, 2018
FDA launches effort to aid clinical development
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has created a five-year pilot program to help drug and biologic companies advance their clinical development programs.
August 28, 2018
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