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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.

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. 

chatgpt artificial intelligence healthcare

OpenAI, the developer of ChatGPT, has made a couple of big hires as it prepares for a major expansion into healthcare.

Pharos PET scanner earns FDA clearance

The system was built with patients in mind, and its compact design has the potential to expand access to the modality where it may have previously been lacking. 

Edwards Lifesciences gains CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system

Though just a small, single-facility study, these findings help care teams know what to look for when performing transcatheter tricuspid valve replacement.

judge court gavel justice system legal

Johnson & Johnson MedTech was already ordered to pay $442.2 million in damages for withholding clinical support to healthcare providers. Now the company has been hit with a permanent injunction designed to stop it from being a repeat offender.

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.