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FDA finalizes Class I recall for Medtronic catheters

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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FDA confirms new recall for Johnson & Johnson heart device over safety concerns

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

Whole-body MRI provider Prenuvo loses bid to limit damages in high-profile malpractice case

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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Integrating prior authorization into clinical workflows cuts costs, speeds up decisions

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

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Ketamine a safe sedation alternative in the interventional radiology suite

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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Insurers fudging payment estimates for radiology services under No Surprises Act

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.

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Hospital lost patient’s skull, offered $25 gas card as recompense, lawsuit claims

Edna Burton underwent a hemicraniectomy to alleviate pressure on her brain after a stroke. When it came time to put an extracted piece of her skull back in place, her family alleges a Detroit hospital was forced to use a prosthetic, having lost the original. They said administrators offered a $25 gasoline card as an apology.

Replaceable doctors, online-only doctors, Dr. Thomas Keane & more healthcare AI news in brief

Medical misdiagnoses account for almost 800,000 deaths and other serious harms every year. Meanwhile healthcare AI is roundly celebrated for its diagnostic prowess. Can’t it help cut out a couple hundred thousand of those horrible mistakes?

Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies.

HHS retracts Richardson Waiver in change to public comment policy

Robert F. Kennedy unveiled the shift in a policy memo. Once it's published to the federal register on March 3, the 1971 Richardson Waiver will be officially repealed.

FDA issues Class I recall on newborn resuscitation devices

The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation.

FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately.

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Cardiovascular Business

FDA finalizes Class I recall for Medtronic catheters