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.

Johnson & Johnson pauses use of FDA-approved PFA system to investigate patient complications

Johnson & Johnson MedTech's Varipulse PFA system has been linked to multiple reports of "neurovascular events" in patients. The company hopes to share more information in the days ahead.

Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.

FDA sees value in no-implant heart failure device

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research.

Top videos on the Cardiovascular Business website about new cardiovascular trends and technologies in 2024.

Top cardiology video interviews in 2024

A list of the most popular video interviews on Cardiovascular Business in 2024 based on reader analytics.

statue justice legal verdict malpractice case lawsuit scale

Cardiology practices pay $17.7M to settle fraud allegations brought on by whistleblowers

A total of 16 cardiology practices from 12 states settled with the DOJ to resolve allegations they overbilled Medicare for imaging agents used to diagnose cardiovascular disease.

older patient with a doctor at their house

‘Fundamental for all patients’: Exploring the benefits of palliative care for stroke survivors

Approximately 800,000 strokes occur each year in the United States alone. A majority of people survive, due in part to key advances in patient care over the years, but they often go forward without receiving the long-term help they need to recover and thrive.

Edwards Evoque transcatheter tricuspid valve replacement TTVR

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement

Edwards Lifesciences sent a formal request to CMS in February after its Evoque TTVR device gained FDA approval. The agency is now accepting public comments for 30 days.

Sahajanand Medical Technologies (SMT) Hydra TAVR

Hydra TAVR valve gains key approval as global reach continues to grow

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

artificial intelligence pharmaceutical industry

FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

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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