Regulatory: Page 11

Califf returns to helm FDA a second time

By AuntMinnie.com staff writers

Dr. Robert Califf will return to lead the U.S. Food and Drug Administration (FDA) a second time after his nomination was confirmed by the U.S. Senate on February 15. Califf previously led the FDA from 2016 to 2017.

February 15, 2022

Circle nets clearance for AI stroke detection software

By AuntMinnie.com staff writers

Cardiac imaging software developer Circle Cardiovascular Imaging subsidiary Circle Neurovascular Imaging has received clearance for its StrokeSens acute stroke detection software from Health Canada and the Therapeutic Goods Administration in Australia.

February 14, 2022

NRC plans to develop rubidium-82 generator requirements

By AuntMinnie.com staff writers

The U.S. Nuclear Regulatory Commission (NRC) recently approved rulemaking that would add performance-based requirements for rubidium-82 generators.

February 10, 2022

Coding changes that will impact radiology practices in 2022

By Erin Stephens

There are 249 new codes in the Current Procedural Terminology (CPT) system that are now in effect for 2022, plus 93 revised codes and 63 deleted codes. Erin Stephens of Healthcare Administrative Partners helps explain what the new codes mean.

January 26, 2022

How will Medicare payment changes impact your radiology practice?

By Sandy Coffta

Now that the final Medicare conversion factor for 2022 of $34.6062 has been established, we can analyze the real impact that radiology practices can expect this year. Sandy Coffta of Healthcare Administrative Partners offers an analysis.

January 19, 2022

Vuze gets FDA nod for intraoperative imaging software

By AuntMinnie.com staff writers

Image-guided surgery software developer Vuze Medical has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vuze System software for image-guided surgery.

January 17, 2022

MRIguidance secures FDA clearance for BoneMRI

By AuntMinnie.com staff writers

Dutch advanced visualization software developer MRIguidance has received U.S. Food and Drug Administration (FDA) clearance for its BoneMRI image processing software.

January 17, 2022

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

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