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.

Profound Medical prostate ablation contouring assistant

Prostate ablation AI 'contouring assistant' lands FDA clearance

The new module is a machine learning-based segmentation tool that further enhances procedural planning.

May 15, 2024

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.

May 14, 2024

The long legal saga of Richard Paulus, a Kentucky cardiologist accused of performing unnecessary cardiac procedures, appears to still be going strong in 2022 and might be reviewed by the Supreme Court. The New York state radiologist is facing 36 misdemeanor counts for secret sexual recording without consent, according to a story in the Boston Herald.

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.

May 9, 2024

United Imaging's 5T whole body MRI receives FDA clearance

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.

May 2, 2024

breast cancer mammography screening mammogram scheduling

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.

April 30, 2024

Take Care of Maya johns hopkins attorneys seek retrial

Reads completed on 'less sophisticated' monitors have radiology group refuting claims of billing fraud in court

The suit claims the group wrongfully billed CMS for over $6 million in image reads that did not qualify for Medicare reimbursement due to the subpar computer monitors used to view the studies.

April 29, 2024

Sectra receives FDA approval for use of DICOM in digital pathology

Sectra receives FDA's first clearance for use of DICOM pathology images

The clearance covers the use of Sectra’s digital review application in conjunction with Leica’s Aperio GT 450 DX scanner.

April 29, 2024

Philips tackling radiology-related manufacturing issues after FDA warning

The Amsterdam-based industry giant has extended its inspection window to ensure that no additional imaging equipment recalls are missed.

April 26, 2024

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.