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. 

approved approval safe

Imaging platform that illuminates residual breast cancer in real-time gets 'historic' FDA approval

LumiSystem enables surgeons to intraoperatively illuminate residual cancerous tissue in the breast cavity during lumpectomy surgery.

April 18, 2024
Money bankruptcy debt liquidation

Private equity bankruptcies in healthcare explode 112% in 5 years

According to the Private Equity Stakeholder Project, 21% of all healthcare bankruptcies in 2023 involved organizations owned by financial firms.

April 18, 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
A gavel and a stethoscope

Atrium Health sued for violating patient privacy, sharing data with Facebook and Google

In a court filing, the plaintiffs claim Atrium Health used Meta's Pixel code on its website, resulting in patients receiving targeted ads.

April 17, 2024

Massive data trove from Change Healthcare hack now for sale on dark web

Cybercriminal group RansomHub claims to have protected health information from nearly every American.

April 17, 2024
PET brain scan

Imaging agent that targets deadly brain tumors given FDA's Fast Track designation

Fast Track designations are typically granted to drugs that target an unmet medical need. 

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