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.

FDA regulator examines AI's growing influence in cardiology
Stephen Browning, the FDA's assistant director of hemodynamics and heart failure diagnostics, spoke with Cardiovascular Business about the agency's perspective on AI-enabled cardiovascular devices and many other topics.
FDA announces another recall for surgical devices over safety concerns—7 new injuries reported
Maquet Cardiovascular, a subsidiary of Getinge, is recalling two of its endoscopic vessel harvesting devices due to issues with different pieces bending, peeling or detaching during use. Some of the company's other EVH devices were recently involved in a separate recall for similar reasons.
Momentum continues for renal denervation as CMS considers national Medicare coverage
CMS is accepting public comments on the topic for a period of 30 days. Recor Medical and Medtronic have both shared statements in support of the potential policy shift.
FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported
Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries.
Why electrophysiologists needed a champion in Washington
Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

doctor examines patient data on their tablet

Advancing AI for vascular surgery will require a commitment to data integrity

For artificial intelligence to truly transform care, the healthcare industry must address certain challenges. Jens Eldrup-Jorgensen, MD, a veteran vascular surgeon and member of the Society for Vascular Surgery, explains in a guest editorial.

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.

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.

‘Incredibly rewarding’: FDA expands total artificial heart study after early success

An additional 15 patients will now receive BiVacor's titanium total artificial heart technology as they wait for a permanent transplant.

HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).

FDA clears credit card-sized heart monitor

The new device was designed to help patients evaluate their own heart health in real time.

Society Society for Cardiovascular Angiography and Interventions (SCAI) President James Hermiller, MD, discusses achievements of SCAI in 2024. #SCAI

SCAI president reviews achievements in interventional cardiology in 2024

SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.

cardiologists evaluating the human heart to provide a treatment strategy

Cardiologists work to standardize the diagnosis and management of acute myocarditis

New expert recommendations from the American College of Cardiology were designed to help cardiologists, primary care physicians, emergency physicians, rheumatologists and other clinicians deliver the best care possible when managing suspected myocarditis.

‘A significant step forward’: Advocates cheer as heart health bill passes Senate

The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.

FDA Commissioner Robert Califf, MD, a cardiologist, speaking at the TCT interventional cardiology conference on health disparities in the U.S. health system and paying more for care has not resulted in better outcomes. #healthdisparities #healthequity

FDA commissioner, a veteran cardiologist, highlights ongoing issues with US healthcare system

FDA Commissioner Robert Califf, MD, talked to Cardiovascular Business about healthcare spending, inconsistent patient outcomes and much more.

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.

Policy & Regulations

FDA regulator examines AI's growing influence in cardiology

FDA announces another recall for surgical devices over safety concerns—7 new injuries reported

Momentum continues for renal denervation as CMS considers national Medicare coverage

FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Why electrophysiologists needed a champion in Washington

Around the web