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.

Stephen Browning, FDA assistant director for hemodynamic and heart failure diagnostics, explains the FDA perspectives and regulatory pathways for AI-enabled cardiovascular devices at TCT 2024.

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.

Recor Medical's Paradise Ultrasound Renal Denervation System

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.

HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.

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.

Dual Energy ThermoCool SmartTouch SF Catheter

Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

A new catheter from Johnson & Johnson MedTech is now approved to treat cardiac arrhythmias in Europe. Could FDA approval be on the horizon?

doctors nurses ai in healthcare fda oversight

Compensation rising for cardiology APPs as they get more involved in patient care

Advanced practice providers continue to play a significant role in cardiology, helping care teams overcome the challenges brought on by an ongoing physician shortage, declining reimbursements and an aging population.

Reimbursement update: What hospitals need to know about new Medicare payments for cardiac CT

CMS finalized a significant policy change when it increased the Medicare payments hospitals receive for performing CCTA exams. What, exactly, does the update mean for cardiologists, billing specialists and other hospital employees?

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.