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.

Boston Scientific’s Farapulse PFA system receives expanded approval
The technology first gained CE mark approval for the treatment of paroxysmal AFib in 2021, when PFA was still brand new. Now, thanks to positive results from the ADVANTAGE AF clinical trial, it is approved for persistent AFib as well.
Cardiology groups to Trump administration: AI still has a long way to go
Multiple cardiology societies responded to an HHS request for public feedback by outlining some of the current barriers to wider AI adoption. "It is essential that any policy frameworks must reaffirm that clinicians—not algorithms—remain at the center of patient care," ACC President Christopher Kramer, MD, said.
Did you make the list? CMS targets cardiologists for new heart failure payment model
More than 2,000 cardiologists are required to participate in the new payment model. According to CMS, the long-term goal is to track and reduce the high healthcare costs associated with treating heart failure.
FDA clears ultrasound AI tool for accurate delivery-date prediction
The cloud-based software service is able to predict a pregnant woman's delivery date using ultrasound imaging alone.
SCAI celebrates new federal funding for PAD prevention
The group's hope is that these new funds will help address the rising rates of PAD and CLTI throughout the United States.

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

Boston Scientific’s Farapulse PFA system receives expanded approval

The technology first gained CE mark approval for the treatment of paroxysmal AFib in 2021, when PFA was still brand new. Now, thanks to positive results from the ADVANTAGE AF clinical trial, it is approved for persistent AFib as well.

artificial intelligence AI policy washington capitol

Cardiology groups to Trump administration: AI still has a long way to go

Multiple cardiology societies responded to an HHS request for public feedback by outlining some of the current barriers to wider AI adoption. "It is essential that any policy frameworks must reaffirm that clinicians—not algorithms—remain at the center of patient care," ACC President Christopher Kramer, MD, said.

cardiologist salary and compensation data

Did you make the list? CMS targets cardiologists for new heart failure payment model

More than 2,000 cardiologists are required to participate in the new payment model. According to CMS, the long-term goal is to track and reduce the high healthcare costs associated with treating heart failure.

FDA clears ultrasound AI tool for accurate delivery-date prediction

The cloud-based software service is able to predict a pregnant woman's delivery date using ultrasound imaging alone.

SCAI celebrates new federal funding for PAD prevention

The group's hope is that these new funds will help address the rising rates of PAD and CLTI throughout the United States.

FDA recall medical device recall product recall

FDA confirms more recalls for Johnson & Johnson heart pumps due to malfunction risk

The issue, first announced to the public in February, has been linked to 22 serious injuries. Customers are urged to review the updated instructions for use to avoid any potential complications.

Radiology artificial intelligence firm asks FDA to exempt certain devices from premarket review

The petition from Harrison.ai has drawn mixed reactions, with AI vendors lending support while radiologists and patient groups worry the move could erode safety.

AHA: ‘Zero trust’ cybersecurity posture necessary to protect hospital data

The National Security Agency released a two-phase plan for all entities within the U.S. Department of War to follow for no-trust cyber defenses. The American Hospital Association said the protocols could be adopted by hospitals.