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. 

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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.

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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.

Philips pulls endovascular devices from market after safety issues prompt Class I recall

Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

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Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

Why cardiac CT adoption remains low among primary care providers

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

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FDA sued over ‘reckless and arbitrary’ semaglutide decision

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

Around the web

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?

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.