Regulatory: Page 12

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

FDA OKs ImmersiveTouch's 3D model software

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to ImmersiveTouch for its modular software that allows users to import, visualize, and automatically segment medical images to create 3D representations.

November 29, 2021

FDA OKs Qmenta's cloud-based platform

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has cleared advanced visualization and image analytics software developer Qmenta's cloud-based Platform for Care.

November 29, 2021

FDA OKs Hyperfine's image reconstruction software

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) has cleared portable MRI developer Hyperfine's new advanced image reconstruction technology using deep learning.

November 28, 2021

FDA clears Therapixel mammo AI software for tomosynthesis

By AuntMinnie.com staff writers

French artificial intelligence (AI) software developer Therapixel's MamoScreen software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with digital breast tomosynthesis.

November 27, 2021

FDA gives nod to MRI safety software tool

By AuntMinnie.com staff writers

A software tool designed to help users analyze the safety of MRI environments has been given the regulatory go-ahead by the U.S. Food and Drug Administration (FDA).

November 15, 2021

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