Regulatory: Page 15

CMS to limit coverage of new drugs for Alzheimer's disease

By Will Morton

The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed a national coverage determination that would limit coverage for drugs like aducanumab only to people enrolled in qualifying clinical trials.

January 11, 2022

FDA postpones inspections due to COVID-19

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) is curtailing inspection activities for the safety of employees in response to the continuing spread of the COVID-19 omicron variant.

January 5, 2022

ADM Diagnostics wins FDA clearance for CorInsights MRI

By AuntMinnie.com staff writers

Brain image analysis software developer ADM Diagnostics has received clearance from the U.S. Food and Drug Administration (FDA) for its CorInsights MRI quantitative image analysis software application.

December 13, 2021

Motilent gets FDA clearance for AI gut imaging software

By AuntMinnie.com staff writers

U.K.-based artificial intelligence (AI) software developer Motilent has received U.S. Food and Drug Administration (FDA) 510(k) clearance for GIQuant, an MR image analysis application for evaluating gastrointestinal function in digestive diseases.

December 13, 2021

FDA publishes paper on 3D-printed medical devices

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) is seeking public comment on a newly published discussion paper on the use of 3D-printed medical devices at the point of care.

December 9, 2021

Hyperfine swoops into Canadian market

By AuntMinnie.com staff writers

Portable MRI technology developer Hyperfine has received a medical device license from Health Canada for its Swoop scanner.

December 9, 2021

AMRA Medical gets FDA clearance for MasS Scan

By AuntMinnie.com staff writers

Swedish image analysis software developer AMRA Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Muscle Assessment Score (MAsS) Scan software.

December 6, 2021

Video from RSNA 2021: Regulatory changes for radiology in 2022

CHICAGO - What regulatory changes will affect radiology in 2022? We talked to Rebecca Farrington, chief revenue officer at coding and billing firm Healthcare Administrative Partners, about the changes that radiology professionals should know about in the coming year.

December 2, 2021

States failed to prioritize cancer patients for COVID-19 vaccines

By Will Morton

Most states winged it with poor results last spring when it came to prioritizing vulnerable cancer patients for COVID-19 vaccines, with guidance from the U.S. Centers for Disease Control and Prevention too broad to be useful, according to research presented December 2 at the RSNA 2021 annual meeting.

December 1, 2021

Canada greenlights distribution of AMRA's muscle scan

By AuntMinnie.com staff writers

Swedish image analysis software developer AMRA Medical has received licensing and is permitted to distribute its Muscle Assessment Score (MAsS) scan in Canada.

December 1, 2021

RefleXion's guided lung radiotherapy designated 'breakthrough'

By AuntMinnie.com staff writers

RefleXion Medical's biology-guided radiotherapy has received a breakthrough device designation from the U.S. Food and Drug Administration for use in treating lung tumors.

November 30, 2021

ACR mulls legal action over No Surprises Act implementation

By AuntMinnie.com staff writers

The American College of Radiology (ACR) is considering taking legal action to stop what it believes to be overreach by insurance companies in the implementation of a new federal law designed to protect patients from surprise billing.

November 30, 2021

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