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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.

FDA recall medical device recall product recall

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.  

Avestēe Women's Imaging Centers

Radiologist Suzanne Dabbous, MD, founded Avestēe Women's Imaging Centers in 2013, expanding the business across San Antonio, Texas.

artificial intelligence AI healthcare regulation FDA

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel. 

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State Attorney General Mike Hilgers said he decided to sue because of Change Healthcare's evident carelessness as well as its slowness to inform potential victims.

Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 

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