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Cook Medical endovascular grafts recalled due to risk of coating breaking off, entering patient’s bloodstream.

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

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Healthcare policies have rapidly evolved in recent years, and 2025 was no exception. From payment policies to physician shortages, ASE and other medical societies had plenty to fight for throughout the year.

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There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

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Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

Prenuvo MRI

Sean Clifford filed the lawsuit Sept. 24, 2024, in the New York State Supreme Court, contending a radiologist failed to spot signs of a forthcoming stroke.   

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This utilization management tactic disproportionately affects specialties such as diagnostic radiology, radiation oncology and cardiology. 

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As IR procedure volumes continue to climb, coupled with anesthesiology provider shortages, there is growing interest in achieving “deeper, more reliable sedation.” 

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A new analysis claims the “benchmark” qualifying payment amount insurers calculate often “dramatically” understates the actual median in-network rates they are paying for in-network care.  

gold card

There is no application process, eligible physicians are automatically approved. In order to earn “gold card status” a practice must have a prior authorization approval rate of 92% or higher for at least the last two years.

An example of HeartFlow's new RoadMap Stenosis software that uses artificial intelligence (AI) to show areas of interest for possible stenting based on a patient's CT scan and FFR-CT. This software is still undergoing beta testing at several hospitals and will likely be rolled out commercially later in 2023.

At its current rate, the number of clinical AI models cleared by the FDA will break 1,000 before the end of 2024. Cardiology continues to play a significant role in this ongoing trend. 

MDMA Ecstasy

The agency has asked for an additional phase 3 study before it considers another application from manufacturer Lykos.

Recor Medical's Paradise Ultrasound Renal Denervation System

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

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Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer.