Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

Prostate ablation AI 'contouring assistant' lands FDA clearance
The new module is a machine learning-based segmentation tool that further enhances procedural planning.
FDA adds more than 120 new AI-enabled medical devices focused on radiology to list of approvals
The FDA has cleared over 150 artificial intelligence- or machine learning-enabled medical devices since the beginning of August.
Radiologist who botched multiple cosmetic procedures calls license revocation 'unfair' in appeals case
The physician's attorneys say that he is being "over punished" for his actions.
First 5T MRI to offer whole-body imaging scores FDA clearance
Houston, Texas-based United Imaging announced the clearance of its uMR Jupiter 5T MRI system, the first to offer an 8-channel whole-body multi-transmit system.
USPSTF stops short of recommending supplemental imaging for women with dense breast tissue
Experts, medical organizations and advocates alike are coming forward saying that the new guidelines “do not go far enough,” particularly when it comes to addressing the screening needs of certain patients.

The AHA is granting more money toward research on the cardIovascular effects of COVID-19. #COVIS #COVID19 #SARSCoV2 #longCOVID

Hospital lays off nearly all its assistant radiologic technologists amid pandemic-driven financial crunch

The 365-bed New York facility recently notified 14 of its 19 assistant technologists that their positions would be eliminated as of Jan. 1.

December 14, 2020

Advocates urge health officials to include front-line imaging workers in plans for first COVID-19 vaccines

“Americans count on our country’s healthcare personnel to care for them, now healthcare personnel look to you to help protect them from COVID-19,” top imaging groups argued recently.

December 9, 2020

COVID-19 congress coronavirus Washington

FDA eases inspection, quality regulations for mammography facilities struggling during COVID crisis

The new guidance is expected to increase the availability of breast imaging services during the pandemic, the administration said recently.

December 4, 2020

Gamma Healthcare halts imaging, lab services after CMS yanks testing certifications

President Jerrod Murphy said he was "blindsided" by the decision from federal regulators, in a report published recently.

November 4, 2020

CMS will delay start of radiation oncology payment model until July

The American Society for Radiation Oncology said it is "pleased" and "thankful" the federal agency listened to the needs of physician practices.

October 22, 2020

FDA yanks imaging facility’s mammography accreditation following quality issues

The agency said it pulled Allison Breast Center’s certificate after it failed to comply with regulations in the Mammography Quality Standards Act of 1992.

September 28, 2020

HCA Healthcare was recently hit with its second antitrust lawsuit — this time from the city of Brevard, North Carolina, for allegedly engaging in anti-competitive schemes.

Patient who suffered ‘life-changing’ gadolinium reaction awaits jury’s medical malpractice decision

The Pennsylvania man's attorneys argued that the hospital and radiologist involved did not follow policies and procedures that would have mitigated his injuries.

August 25, 2020

FDA clearance news: Hyperfine’s portable MRI nod, RapidAI takes on LVOs, and more market moves

Also, Bayer receives the go-ahead for its MRI contrast bulk packaging option and United Imaging unveils a new PET noise-reduction platform.

August 14, 2020

Around the web

Cardiovascular Business

AI improves CT assessments, boosts care for real-world heart patients

Automated AI-generated measurements combined with annotated CT images can improve treatment planning and help referring physicians and patients better understand their disease, explained Sarah Jane Rinehart, MD, director of cardiac imaging with Charleston Area Medical Center.

Cardiovascular Business

AI predicts cardiovascular risk during CT scans—no invasive tests or contrast required

Two advanced algorithms—one for CAC scores and another for segmenting cardiac chamber volumes—outperformed radiologists when assessing low-dose chest CT scans.

Radiology Business

Google teams with Bayer to address radiologist burnout via AI

"Gen AI can help tackle repetitive tasks and provide insights into massive datasets, saving valuable time," Thomas Kurian, CEO of Google Cloud, said Tuesday.

Policy & Regulations

Prostate ablation AI 'contouring assistant' lands FDA clearance

FDA adds more than 120 new AI-enabled medical devices focused on radiology to list of approvals

Radiologist who botched multiple cosmetic procedures calls license revocation 'unfair' in appeals case

First 5T MRI to offer whole-body imaging scores FDA clearance

USPSTF stops short of recommending supplemental imaging for women with dense breast tissue

Around the web