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. 

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pharmaceutical drug approval process

FDA grants fast track designation to new drug for Friedreich's ataxia cardiomyopathy

The new gene therapy candidate is now one step closer to being approved by the FDA. 

HeartMate 3 LVAD abbott

FDA announces new recall of Abbott’s HeartMate LVADs after 14 deaths

The issue at the center of this recall, which includes both the HeartMate II and HeartMate 3 LVAD, is the gradual buildup of biological materials. This can impact the device's performance, creating a heightened risk of injury or death. 

Healthcare systems set up at the ACC.24 career fair in hopes of filling open positions, including a large and growing number of general cardiologist positions. Photo by Dave Fornell #ACC24 #ACC2024

The growing shortage or general cardiologists and recruiting crisis in rural America

There is a rapidly growing shortage in general cardiologists and for positions in rural areas, numerous healthcare system recruiters set up at the ACC reported.

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Watchdog group calls out risks associated with private equity in cardiology, other specialties

U.S. Senator Elizabeth Warren, an outspoken critic of private equity's influence, praised the group's efforts. "Together, we’re taking on this trillion-dollar, behemoth industry that’s hurting working people and sucking money out of the rest of the economy," she said. 

Medicare drops AUC requirement for advanced imaging, ASNC celebrates

"This was an unneeded burden, which was solely adding to the administrative hassles of medicine," said American Society of Nuclear Cardiology President Larry Phillips.

FDA announces new recall of neurovascular catheters built by Johnson & Johnson subsidiary

The recall is due to ongoing concerns about the devices breaking. Three patients have been injured as a result of this issue.

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On-pump vs. off-pump CABG: No difference in long-term mortality, meta-analysis confirms

Researchers explored data from nearly 70,000 patients, sharing their findings in the American Journal of Cardiology.

the words "FDA recall" on a board

FDA announces recall of more than 300,000 catheter kits after 10 injuries, 1 death

This recall is due to reports of “increased resistance” when using the devices. There have been 194 customer complaints about the issue so far. 

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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.

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