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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.

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. 

lung cancer screening low-dose CT

Lung cancer remains the leading cause of cancer-related deaths in the United States. It is estimated that it claims approximately 125,000 lives in the U.S. every year.

TactiFlex Duo Ablation Catheter, Sensor Enabled

The TactiFlex Duo Ablation Catheter, Sensor Enabled was designed to switch from PFA to radiofrequency ablation as needed, providing electrophysiologists with options when treating AFib patients.

breast cancer mammography screening mammogram scheduling

This new imaging approach has the potential to benefit women with both high and low risk of developing cancer, researchers charge. 

Anthony Fletcher, MD, FACC FAHA, FSCAI, president of the Association of Black Cardiologists (ABC), and an interventional cardiologist at CHI St. Vincent Heart Clinic Arkansas, Little Rock, explains the results of a recent ABC survey looking at the level of awareness among providers and communities in cardiology care deserts in the South. He said there was a poor level of understanding about LDL-C management and Lp(a) awareness among both primary care providers and patients in these underserved areas.

Association of Black Cardiologists President Anthony Fletcher, MD, discusses the group's efforts to educate patients in Louisiana, Arkansas, Georgia and Mississippi.

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.