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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Tom Price, MD, an orthopedic surgeon and former secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it.

Former HHS secretary says healthcare needs to fight back against medical misinformation

Tom Price, MD, an orthopedic surgeon and secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it. 

Foldax Tria mitral valve

‘A compelling alternative’: Polymer heart valve receives first commercial approval of its kind

A new surgical mitral valve from Foldax will now be commercially available in India. The valve is built using LifePolymer, a proprietary material that does not include animal tissue.

Dean Kereiakes, a nationally renowned interventional cardiologist and president of The Christ Hospital Heart and Vascular Institute, has long been recognized for his groundbreaking work in cardiovascular research and intervention. But in 2024, his career and his life were permanently altered when decades of wearing heavy lead protection in the cath lab left him paralyzed.

Cardiologist became paralyzed after wearing heavy aprons in the cath lab for decades—but he fought back

Dean J. Kereiakes, MD, was left paralyzed after battling severe orthopedic issues for his entire career. Back in the cath lab after a long recovery, he is now stressing the importance of workplace safety among interventional cardiologists.

AMA brainstorms on key topics impacting healthcare

"With significantly strengthened penalties, standardized reporting requirements and unprecedented enforcement commitments, the regulatory landscape has dramatically shifted," the AMA wrote. 

Surgeons in Houston have performed the world’s first successful human implant of BiVACOR’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023.

FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.

Reflow Medical Spur Peripheral Retrievable Stent System

New-look peripheral stent with expandable spikes receives FDA’s de novo classification

California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.

Rishi Wadhera, MD, MPP, MPhil, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, and an associate professor of health policy and management, Harvard School of Public Health, explains the impact of private equity ownership of hospitals and private practices.

Private equity's influence continues to rise in cardiology—what does that mean for patient care?

Rishi Wadhera, MD, MPP, MPhil, a cardiologist who also specializes in healthcare policy, spoke to Cardiovascular Business about the good, the bad and the unknown when it comes to private equity's role in cardiology.

Cuffless blood pressure measurement devices: Convenient, but not ready for clinical use

Cuffless BP measurements could potentially provide significant value for clinicians and patients alike. It is still too early, however, for these technologies to be used in a clinical setting; too many unanswered questions remain.

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Around the web

Health Exec
Tom Price: Medical residency slots need to expand to combat physician shortages

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

Health Imaging
Tariffs will have a significant impact on the nuclear imaging supply chain in the US

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.