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.

CMS approves Medicare coverage for transcatheter tricuspid valve replacement
CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.
Safety update: FDA announces Class I recall due to atherectomy devices breaking during use
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.
FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths
One product is being pulled from the market, and the other is receiving updated instructions for use.
FDA clears first generic versions of rivaroxaban—what it means for patient care
Dave Dixon, PharmD, explored the short- and long-term impact of these approvals, noting that they could help reduce costs down the line.
American College of Cardiology shares new guidance focused on evaluation, management of cardiogenic shock
The new document represents the ACC’s first Concise Clinical Guidance; it was designed to be an easy-to-use reference for keeping track of a complicated topic.

Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)

CMS approves Medicare coverage for transcatheter tricuspid valve replacement

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

Bard Peripheral Vascular Rotarex Atherectomy System recall

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

One product is being pulled from the market, and the other is receiving updated instructions for use.

Video of Dave Dixon explaining the impact of first FDA approval of a generic DOAC.

FDA clears first generic versions of rivaroxaban—what it means for patient care

Dave Dixon, PharmD, explored the short- and long-term impact of these approvals, noting that they could help reduce costs down the line.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

American College of Cardiology shares new guidance focused on evaluation, management of cardiogenic shock

The new document represents the ACC’s first Concise Clinical Guidance; it was designed to be an easy-to-use reference for keeping track of a complicated topic.

FDA clears AI-assisted CCTA software that assesses plaques for signs of heart disease

Caristo Diagnostics, an Oxford-based medtech company founded by cardiologists, has gained FDA clearance for its CaRi-Plaque technology.

congress money legislation lawmaker bill senate house senator representative

Cardiology groups urge Congress to ‘take a stand’ after spending proposal fails to fix Medicare cuts

A new spending proposal that would extend government funding for another seven months does not address the Medicare payment cut that went into effect on Jan. 1. More than 100 healthcare groups, including the ACC, STS, SCCT and SCAI, are now voicing their disappointment.

Corcym has received U.S. Food and Drug Administration (FDA) approval for a new version of its Perceval Plus surgical aortic heart valve that includes the company’s advanced LANCELOT features.

FDA approves design updates for Perceval Plus surgical aortic valve

The valve's sutureless, collapsible frame was built to simplify implantation and help patients recover faster following surgery. This updated version features laser-cut details and was shaped using a zero-pressure fixation process.

Around the web

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The impact of Trump tariffs on iodine contrast media costs

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

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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.