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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. 

oprah-at-ct-scanner-blessing-with-kahu-kimokeo-and-imaging-director-kelly-combs_web-1024x682.jpeg

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. 

Nurse in Handcuffs

Sixty-one-year-old Lilit Gagikovna Baltaian, MD, is on the run after being convicted of fraudulently billing Medicare alongside co-conspirators at home health agencies. A federal court in California sentenced her to 54 months in prison.

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A communication error within the system can reportedly cause loss of imaging functionality mid-procedure.

Air India

Dr. Prateek Joshi, with the NHS hospital in Derby, England, was taking his wife, also a highly regarded physician, and three young children from India to the U.K. to start a new chapter. 

Hemal Gada, MD, cardiologist

The EARLY TAVR clinical trial made a significant impact, paving the way for the FDA to approve multiple transcatheter heart valves for the treatment of asymptomatic patients. However, one cardiologist who participated in the trial has some serious concerns with how its findings were presented to the public. 

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.