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. 

Newsweek ranked the 50 best heart hospitals in the world

3 in 5 US adults projected to have CVD by 2050, with a price tag of $1.8T—can cardiologists ‘turn the tide’?

More than 60% of adults in the United States are expected to have at least one form of cardiovascular disease by 2050, according to new data published by the American Heart Association. Fortunately, evidence does suggest that healthier lifestyles are starting to become more common as time goes on.

HeartFlow Plaque Analysis

AI-based coronary plaque assessments 1 step closer to Medicare coverage

According to a new proposal, using AI to evaluate CCTA results and quantify plaque buildup is “reasonable and medically necessary” in certain clinical scenarios.

alternative approaches for transcatheter aortic valve replacement procedures

Transcaval TAVR a safe, effective alternative for patients with severe AS

Researchers examined data from eight different studies, noting that transcaval TAVR appears to be a "viable alternative" when transfemoral access is not an option. The procedure was linked to an overall success rate of 98.5%.

The U.S. Food and Drug Administration (FDA) announced that Vyaire Medical has recalled the twin tube samples lines from its Vyntus CPX Metabolic Cart due to ongoing safety concerns. This is a Class I recall, which means the FDA believes using these devices “may cause serious injuries or death.”

FDA announces new Class I recall of CPET devices due to choking hazard

If left unchecked, the devices could put patients at risk of serious injuries or death as they undergo cardiopulmonary evaluations. 

Hospira, an Illinois-based pharmaceutical and medical device company owned by Pfizer, has issued a voluntary recall of two different drugs due to ongoing safety issues. The recall includes specific lots of labetalol hydrochloride injections and buprenorphine hydrochloride injections. Labetalol hydrochloride injections are used to control blood pressure in patients with severe hypertension.

Pfizer recalls 2 drugs, including 1 for hypertension, over safety concerns

The recall was put in place due to a leak risk that could make the therapies less effective and potentially lead to an infection. 

doctor examines patient data on their tablet

AVR for moderate AS: New 10-year data highlight clear benefits of TAVR, surgery

New research out of Cleveland Clinic explored long-term outcomes among patients with moderate aortic stenosis who were treated with TAVR, SAVR or clinical surveillance. TAVR and SAVR were both associated with clear improvements compared to surveillance alone. 

Women remain underrepresented in revascularization trials—can cardiology leaders reverse that trend?

“If together we do not just hope for, but demand, adequate representation as a necessary criterion for high-quality studies worthy of adoption into practice, we will have a real shot at achieving true equity in our trials," cardiologists said in a new commentary.

Jerry Blackwell, MD, MBA, FACC, president and CEO of MedAxiom, said iIt is no longer enough to just be a cardiologist making clinical decisions, they also need to be much more aware the business side of healthcare. #Cardiologybusiness #CVBusiness #CMS #Cardiology #ACC #ACC2024 #Medaxiom

Business concerns over costs and thin margins means it is no longer enough to just be a cardiologist

Cardiologist Jerry Blackwell, MD, president and CEO of MedAxiom, believes cardiologist can't just focus on clinical decisions, as they also must be aware the financial ramifications. 

Around the web

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

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