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.

FDA fast tracks SPECT imaging agent targeted toward interstitial lung disease

Experts believe the imaging agent "has the potential to meaningfully advance early diagnosis, change the treatment paradigm and improve patient outcomes."

Universal heart screening for all athletes? Not so fast, cardiologists warn

Mandates for universal ECG screening are gaining momentum as a way to combat the risk of SCA. However, the ACC warned, modern healthcare systems were not built to withstand such a rise in demand. These mandates will also result in higher costs and other unintended consequences.

Kansas and New Jersey the latest to introduce supplemental breast imaging legislation

The two join several others that have also done so in 2026 including Alabama, Arizona, California, Hawaii, Rhode Island and South Carolina.

3 accomplished AI innovators worry anew over their mind-of-its-own creation

Recent days have seen some nerve-rattling brain dumps about the near future—including five figurative minutes from now—authored by tech luminaries who specialize in AI innovation.

AI-powered lung cancer screening support tool nabs FDA clearance

The software was designed to address issues with inter-reader variability common to LDCT screenings.

Rich Fabian, Medical Imaging Technology at AdvaMed Imaging chair of board, a medtech industry group made up of medical imaging companies to address higher level trends and public policy concerns, said tariffs are having a major impact for all vendors due to diverse supply chains that cannot be changed overnight. He said the U.S. tariffs and counter tariffs from, various countries will raise costs for U.S. health systems at a time where margins for them are already razor thin. #RSNA

Medical imaging industry group shares tariff concerns

AdvaMed, a medtech industry group made up of medical imaging companies, says tariffs are having a major impact for all vendors.

Reprocessed EP catheters recalled due to contamination risk

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer.

5 takeaways from Dr. Wachter’s ‘Giant Leap’ with AI in healthcare

Someday the computerization of medicine will be recognized as the game-changing, paradigm-shifting, everything-upending “disruptive innovation” that so many healthcare watchers and stakeholders have been waiting for. “Today,” however, “it’s often just plain disruptive.”

Policy & Regulations

Boston Scientific’s Farapulse PFA system receives expanded approval

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

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

FDA clears ultrasound AI tool for accurate delivery-date prediction

SCAI celebrates new federal funding for PAD prevention