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FDA recall medical device recall product recall

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.

insurance insurer payment claim denial reimbursement prior authorization

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.

IV hospital room intravenous drip solution

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.”

healthcare surprise billing statement payment

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.

statue justice legal verdict malpractice case lawsuit scale

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?

Medtronic’s MiniMed 780G automated insulin delivery system

Medtronic’s diabetes spin-off files for IPO

Make way for MiniMed! Medtronic's diabetes division has filed the necessary paperwork to go public. The company hopes to be traded on Nasdaq under the symbol MMED.

VI-RADS threshold, imaging features predict bladder cancer invasiveness with nearly 100% accuracy

New findings related to Vesical Imaging-Reporting and Data System scores and specific MRI findings could improve the management of bladder cancer.

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.

Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology.

FCI scanner more ably detects cancer spread than traditional MRI

New low-field scanner detects cancer spread better than traditional breast MRI

Researchers involved in its development are hopeful that the scanner could eventually lead to improved outcomes in cancer patients who require surgery to remove malignant tissue.

Around the web

Cardiovascular Business

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.