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. 

RSS icon

FDA announces new Class I recall of troubled heart devices

The recall includes approximately 2,300 devices distributed to customers prior to July 24, 2017. There have been 44 complaints about this issue so far.

Sphere-9 mapping and ablation catheter

Medtronic gains key approval for new mapping and ablation system

Medtronic acquired the technology in a 2022 deal reportedly worth $925 million.

venture capital corporate suit business corporatization

Medtronic, Edwards among the healthcare organizations chosen as World’s Most Ethical Companies in 2023

The annual list, now in its 17th year, was designed to celebrate companies that make ethical business practices a high priority. 

Thumbnail

Cardiologists warn Biden administration that new policies could put PAD patients at risk

SCAI and the Association of Black Cardiologists have joined forces to share a simple message: PAD patients would be negatively impacted by new CMS proposals. 

The Millipede 088 Access Catheter. Image courtesy of Perfuze. FDA clearance.

Regulatory Roundup: FDA clears 2 new solutions, declines to approve omecamtiv mecarbil for HFrEF

Read our monthly recap of FDA-related news items from the world of cardiovascular medicine. 

Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.

FDA warns that early deterioration is possible with Abbott’s Trifecta heart valves

Early SVD has been reported in these devices, particularly three to four years after implantation. According to the FDA, this has resulted in surgical replacement procedures and transcatheter valve-in-valve interventions. In some cases, the patient died.

Harmony transcatheter pulmonary valve

Medtronic relaunches Harmony TPV system after 2022 recall

The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States. 

PCI

New ACC/AHA/SCAI guidance highlights training requirements for interventional cardiologists

The document, which was designed to help guide both interventional cardiology trainees and program directors, was also endorsed by several other industry societies. 

Displaying 313 - 320 of 438

Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Design by Adaptive Theme
Trimed Popup
Trimed Popup