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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Boston Scientific’s Agent Drug-Coated Balloon (DCB), which delivers a therapeutic dose of the anti-proliferative drug paclitaxel to the patient’s scar tissue to prevent ISR from recurring, gained FDA approval on March 1..

Cardiologists share historic research that led to FDA’s long-awaited approval of coronary DCB

When Boston Scientific’s coronary DCB gained approval in the United States, it was a moment the country's cardiologists had been looking forward to for years. The cardiologists who researched the device have now detailed their findings, highlighting the "unmet need" this technology is addressing. 

March 14, 2024
Elderly patient doctor. Despite an expanded indication from the FDA and lower prices, patient access to these cholesterol-lowering medications remains a significant issue.

Cognitive impairment among heart failure patients: How cardiologists can help

The Heart Failure Society of America shared a new scientific statement about this topic, noting that many patients may require additional help.

March 13, 2024
Recall | Product recall

Abbott recalls device for tracking LVAD data after 8 injuries

This is a Class I recall, which means using the device “may cause serious injuries or death.” However, the FDA emphasized that this is a correction and not a product removal.

March 11, 2024
Medicare data stethoscope healthcare trends graphs finance financials

ACC, SCAI say new funding bill did not do enough to limit Medicare reimbursement cuts to cardiology services

President Joe Biden signed a funding bill worth $460 billion on March 9, but it only included partial relief for cardiologists, cardiac surgeons and other cardiology professionals. 

March 11, 2024
Weekly doses of semaglutide, a GLP-1 receptor originally developed to treat diabetes, could help approximately 93 million U.S. adults lose weight and reduce their risk of adverse cardiovascular events, according to new research published in Cardiovascular Drugs and Therapy. Novo Nordisk sells and markets subcutaneous treatments of semaglutide 2.4 mg under the brand name Wegovy.

A big win for Wegovy: Weight loss drug semaglutide first in history to gain FDA approval for reducing heart risks

The FDA made a special announcement about its decision, describing the news as "a major advance for public health."

March 8, 2024
Patients who take diuretics, renin-angiotensin system (RAD) inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) at the same time face a much higher risk of developing acute kidney injury (AKI)

Some older patients taking aspirin to prevent CVD may be doing more harm than good

“Aspirin is no longer a one-size-fits-all preventive tool for older adults," according to one specialist with Michigan Medicine. 

March 7, 2024
Product Recall

FDA announces new Class I recall of drainage systems after 26 injuries

According to the agency, using these devices “may cause serious injuries or death.”

March 7, 2024
Dexcom, a global healthcare technology company based out of San Diego, has received the first over-the-counter U.S. Food and Drug Administration (FDA) clearance for a wearable glucose biosensor that can be obtained without a prescription, the Stelo..

FDA clears first over-the-counter wearable device for continuous glucose monitoring

The newly cleared device is worn on the back of the arm and sends data directly to the user's smartphone. 

March 6, 2024
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Around the web

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.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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