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Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA. 

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Maui Memorial Medical Center, a 214-bed acute care hospital in Wailuku, celebrated the new computed tomography machine with its imaging team on June 8. 

FDA issues recall of imaging systems

A handful of fluoroscopy units manufactured by GE HealthCare are the subject of a new recall by the U.S. Food and Drug Administration. 

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The team’s work will emphasize the role of specialized MRI techniques capable of detecting subtle changes around tumors with the help of pH-based imaging.

California-based Penumbra has received U.S. Food and Drug Administration (FDA) clearance Thunderbolt, a new computer-assisted vacuum thrombectomy (CAVT) device designed to treat acute ischemic stroke.

The Thunderbolt device from California-based Penumbra uses modulated aspiration to detect and remove blood clots. Back in January, Boston Scientific agreed to acquire Penumbra for approximately $14.5 billion.

Sapien 3 Ultra Resilia TAVR valves

Researchers tracked real-world data from more than 140 patients who originally received a transcatheter heart valve from Edwards Lifesciences, Medtronic or Boston Scientific. 

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The new recall impacts thousands of portable systems. A software update is now available that should resolve any issues. 

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The exam should be performed on patients with greater than 10 years of life expectancy and between the ages of 50 and 70, with earlier imaging recommended for black men. 

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The Promoting Fairness for Medicare Providers Act seeks to smooth out reimbursement differences between office- and hospital-based settings. 

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Rep. Mike Simpson, R-Idaho, announced the news on June 10, with the money going toward Madison Memorial Hospital in Rexburg. 

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The ratings agency contends RadNet is constrained by its geographic concentration in 11 states and high fixed costs, including sizable interest expenses. 

insurance insurer payment claim denial reimbursement prior authorization

A pilot program to use artificial intelligence to approve or deny traditional Medicare claims is currently active in six states. If successful, an amendment from the U.S. House of Representatives Appropriations Committee would block its expansion.

Around the web

Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA. 

Maui Memorial Medical Center, a 214-bed acute care hospital in Wailuku, celebrated the new computed tomography machine with its imaging team on June 8. 

A handful of fluoroscopy units manufactured by GE HealthCare are the subject of a new recall by the U.S. Food and Drug Administration.