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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Cardiology groups share key update: ABMS seeking feedback on proposed Board of Cardiovascular Medicine

Five of the largest U.S. medical societies focused on cardiovascular health are one step closer to seeing their paradigm-shifting proposal become a reality.

April 25, 2024
Expanse ICE, a new healthcare technology company born out of the Expanse Medical medical device incubator, has received U.S. Food and Drug Administration (FDA) clearance for its new-look catheter to treat blood clots in the peripheral arteries and veins.

FDA clears new catheter for peripheral blood clots

The new-look catheter came out of a medical device incubator started by entrepreneur Eitan Konstantino, PhD, who has years of experience in the vascular space. 

April 25, 2024
noncompete contract clause employment pen sign

Cardiologists, thoracic surgeons applaud FTC’s ban of most noncompete clauses

The Society for Cardiovascular Angiography & Interventions and Society of Thoracic Surgeons have both shared statements in support of the ban, which is already being challenged in court. The American Hospital Association, meanwhile, opposes the policy shift, saying it “errs by seeking to create a one-size-fits-all rule”

April 25, 2024
Alison Bailey, MD, FACC, chief of cardiology, Centennial Heart at Parkridge Medical Center, and a physician director of cardiovascular disease for HCA Healthcare. She was the co-chair of a four-part series on the business of cardiology sessions at ACC 2024. She explains why ACC chose to concentrate on business. #ACC #ACC24 #ACC2024 #Cardiologybusiness

Why the business side of cardiology was a key focus at ACC.24

Alison Bailey, MD, co-chair of the business of cardiology sessions at ACC.24, emphasized that reimbursement cuts can have a long-term negative impact on patient. 

April 24, 2024
2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.

Q&A: Interventional cardiologist details key breakthroughs in tricuspid valve replacement and repair

How have recent FDA approvals for Edwards Lifesciences and Abbott changed patient care? Andrew Rassi, MD, answered that question—and many more—in a new interview. 

April 18, 2024
the words "FDA recall" on a board

Boston Scientific recalls premixed embolic agent after two deaths

There have been a total of 11 incidents so far, including seven injuries and two deaths. Boston Scientific said the agent can still be used if operators follow specific instructions during lower GI bleed embolization procedures.  

April 17, 2024
Video interview with ACC President Cathie Biga on goals for college over the next year and trends she saw at ACC 2024.

New ACC President Cathie Biga wants to improve quality reporting in cardiology

Biga, who originally trained as a nurse, specializes in the business side of cardiology. She also emphasized the increasing importance of AI and other new technologies. 

April 17, 2024
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. 

April 17, 2024

Around the web

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

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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