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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.

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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Leqembi (lecanemab) was approved by the FDA in 2023. It is an infusion drug that has been shown to reduce Alzheimer’s-related cognitive decline by up to 27%. 

GE HealthCare Vivid Pioneer cardiovascular ultrasound

The company describes Vivid Pioneer as its “most advanced, ultra-premium and adaptive cardiovascular ultrasound system yet.” It includes new and improved AI capabilities and a compact design that is still fully functional in tight workspaces. 

UnitedHealthcare

Rad Partners "firmly" denied the allegations, which mirror a similar complaint from Aetna, contending it plans to "vigorously defend against these claims" in court. 

judge court gavel justice system legal

After losing a court battle with the Fortune 500 company last year, Jeffrey C. Allard, MD, and attorneys are homing in on an attorney's faulty credentials, claiming she "poisoned" the proceedings. 

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.