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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. 

Medicare money payment physician

The Small Business Administration will raise receipts-based standards for 263 industries including imaging, allowing more to apply for financing.

money cybersecurity ransomware health IT data breach hacker

Vital Imaging Diagnostic Centers recently alerted patients about the apparent cyberattack with an unauthorized party likely gaining access to private health information. 

U.S. FDA Sign

The company is seeking approval for TLX250-CDx (brand name Zircaix), a novel PET (positron emission tomography) product geared toward kidney cancer. 

night school adult education

A new analysis published in Artificial Intelligence in Medicine argues that education tools are failing to show clinicians how to make use of new technologies, calling into question the benefit of rapid adoption. 

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.