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. 

HeartMate 3 LVAD abbott

No aspirin, no problem: FDA approves key update for Abbott heart pumps

Patients have typically been told to take aspirin and an oral anticoagulant following treatment to help combat the risk of blood clots. Now, they can skip the aspirin altogether.

pharmaceutical drug approval process

Drugmaker to ‘challenge’ FDA after only receiving tentative approval for inhaled PAH treatment

An exclusivity agreement is stopping Liquidia Corporation from gaining full FDA approval of its new inhalation powder for pulmonary arterial hypertension. The company said it is disappointed with the agency's decision and plans to "take quick action."

Ron Blankstein, MD, FACC, FASNC, MSCCT, FASPC, associate director, cardiovascular imaging program, director, cardiac computed tomography, Brigham and Women’s Hospital, and a professor of medicine and radiology, Harvard Medical School, explains why Medicare is proposing increased coronary computed tomography angiography (CCTA) payments to hospitals.

Higher payments for CCTA could bring considerable change to cardiology

Ron Blankstein, MD, explains how and why Medicare is proposing an increase to hospital payments for coronary CT angiography.

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Reduce, reuse, recycle: How cath labs can lower cardiology’s colossal carbon footprint

Cath labs, like radiology suites and operating rooms, are leading contributors to the world’s growing carbon footprint.

money business cash flow dollar

White House unveils lower prices for popular heart, diabetes drugs after Medicare negotiations

Apixaban, empagliflozin, rivaroxaban and sacubitril/valsartan are just some of the medications included in this initial round of Medicare price negotiations. Their new prices were reduced by 56%, 66%, 62% and 53%, respectively. 

Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

Crisis averted: Recalled heart pumps found after being sent to customers by mistake

The FDA warned that the devices failed a safety inspection, but were still distributed for patient use. They have now all been located. 

cardiologists evaluating the human heart to provide a treatment strategy

Managing stable angina: How cardiologists can find the right mix of revascularization, therapy and interventions

The management of stable angina has been evolving at a rapid rate. Using a one-size-fits-all strategy is becoming a thing of the past, replaced by a patient-centered approach that requires open communication and a healthy understanding of recent clinical research.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Patient risks persist for insulin pump caught in Class I recall

A software update for the pump's mobile app was expected to fix ongoing battery issues, but the problem remains. 

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.

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