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. 

RSS icon
HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

Heart Rhythm Society launches new group focused on EP advocacy

The new organization, Heart Rhythm Advocates, will urge federal policymakers to pass legislation and support actions that have a positive impact on the future of electrophysiology.

EARLY TAVR investigator Philippe Généreux, MD, announced his team’s findings in front of a packed audience at TCT 2024.

Treating asymptomatic aortic stenosis with TAVR linked to significant benefits

Attendees cheered as lead investigator Philippe Généreux, MD, shared his team's findings at TCT 2024. “A major reset in our approach to severe asymptomatic AS is now warranted,” one veteran cardiologist said about the data. “The concept of watchful waiting is no longer appropriate."

robot reviewing heart data

Medicare coverage expands again for AI-enabled coronary plaque assessments

Another MAC has agreed to cover the use of these advanced technologies to evaluate patients for signs of coronary artery disease. 

Medtronic Evolut FX+ TAVR

Medtronic’s next-generation TAVR device receives CE mark approval

The Evolut FX+ TAVR system, which already received FDA approval in March, was designed with improved coronary access in mind. One cardiologist described the device as a "significant step forward" for patients with heart disease. 

heart doctors and surgeons working together. top cardiology hospitals in the United States.

Cardiothoracic surgeons unite to improve clinical practice guidelines

Four leading cardiothoracic surgery societies have joined forces in the name of developing clinical practice guidelines that are more thorough and consistent.

Thumbnail

Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Farawave Nav ablation catheter for the treatment of paroxysmal atrial fibrillation (AFib) and FDA clearance for its new Faraview software

Boston Scientific scores 2 key FDA approvals for PFA mapping technology

The two newly approved technologies are used together to help visualize cardiac ablation procedures performed with Boston Scientific’s Farapulse pulsed field ablation system.

Displaying 49 - 56 of 473

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.