Regulatory: Page 16

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

Philips receives clearance for liver fat quantification tools

By AuntMinnie.com staff writers

Philips recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its liver fat quantification tools.

November 15, 2021

Probe of COVID pandemic response puts Atlas back in news

By AuntMinnie.com staff writers

Controversial neuroradiologist Dr. Scott Atlas is back in the headlines. A subcommittee of the U.S. House of Representatives that's investigating the Trump administration's response to the COVID-19 pandemic criticized Atlas for what it said was his role in changing federal guidelines for COVID-19 testing.

November 14, 2021

CMS officially kills 'breakthrough' medical device program

By AuntMinnie.com staff writers

It's official. The U.S. Centers for Medicare and Medicaid Services (CMS) has killed a Trump administration-era program to promote the development of "breakthrough" medical devices.

November 14, 2021

Biden taps Califf to once again lead FDA as commissioner

By Brian Casey

It's back to the future at the U.S. Food and Drug Administration (FDA). President Joe Biden on November 12 tapped cardiologist Dr. Robert Califf to lead the agency as commissioner, a role he held from 2016-2017.

November 11, 2021

HeartVista brings AI software to Siemens MRI scanners

By AuntMinnie.com staff writers

Cardiac MRI artificial intelligence (AI) software developer HeartVista has received U.S. Food and Drug Administration 510(k) clearance to market its One Click MRI acquisition software for MRI scanners from Siemens Healthineers.

November 9, 2021

ACR sees benefits for radiology in the 2022 HOPPS rule

By AuntMinnie.com staff writers

The U.S. Centers for Medicare and Medicaid Services' on November 2 released its final rule for the 2022 Medicare Hospital Outpatient Prospective Payment System, and the American College of Radiology (ACR) sees some benefits for radiology.

November 3, 2021

ICD-10 coding changes your radiology practice should know

What updates that affect radiology practices have been made to the International Classification of Diseases Clinical Modification (ICD-10-CM) coding system? We talked to Erin Stephens, client manager of education at Healthcare Administrative Partners, about the recent changes.

November 3, 2021

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