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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.  

Smith Medical FDA issues BLU tracheostomy tubes FDA recall

The Smiths Medical BLUSelect and related products have a manufacturing defect and must be removed from stocks immediately. 

MGMA's Anders Gilberg discusses concerns on Medicare physician fee schedule

The Medical Group Management Association (MGMA) Senior Vice of Government Affairs, Anders Gilberg, explains MGMA’s 28-page letter to CMS on issues with the proposed 2025 Medicare Physician Fee Schedule.
 

Medtronic's Affera mapping and ablation system with the Sphere-9 catheter

Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of persistent AFib. The company’s PulseSelect PFA system gained approval in December 2023. 

The Shockwave Medical M5+ new peripheral intravascular lithotripsy (IVL) catheter cuts procedures times in half and was showed for the first time at the American College of Cardiology (ACC) 2022 meeting. It is designed to break up calcium in heavily calcified arteries to avoid the need for vessel trauma caused by high pressure angioplasty.

Patient outcomes for these two treatments are similar, but choosing IVL may help improve clinical workflows. 

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