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artificial intelligence

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.

Nashville Tennessee

The company called the state’s regulation of pharmacy benefit managers “shortsighted,” as it would force the closure of Accredo, a specialty drug dispensary that supplies drugs it says aren’t available anywhere else in the state.

Optum UnitedHealthcare UnitedHealth Group HQ

The agency had been suing the three largest pharmacy benefit managers over their alleged control of insulin prices. It reached agreements with CVS’ Caremark and Cigna’s Express Scripts earlier this year.

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. 

The doctor is accused of using fake credentials for several months and performing approximately 50 procedures. This is the second time in recent months someone has been accused of impersonating a heart specialist and treating patients.

business launch

The new name will be familiar to anyone who knows the history of Medtronic's diabetes business.

artificial intelligence AI in healthcare

The Joint Commission is partnering with the Coalition for Health AI to scale AI accountability. The project will supply more than 80% of U.S. provider orgs with gameplans, toolkits and overall guidance. 

Imagers reviewing flurpiridaz F-18 (Flyrcado) myocardial perfusion PET images. Image from GE Healthcare

The new F-18 flurpiridaz radiotracer is expected to help drive cardiac PET growth, but it requires waiting between rest and stress scans. Software from MultiFunctional Imaging can help care teams combat that problem.

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.