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Factors making healthcare AI devices more likely to face recall

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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Oprah Winfrey blesses new CT scanner she helped fund in Hawaii

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.

'Risk of electrical shock' prompts 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.

Researchers land $3.2M grant to advance MRI's role in diagnosing glioblastoma

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.

FDA clears new computer-assisted device for removing clots in stroke patients

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.

Redo TAVR with balloon-expandable valves linked to positive outcomes, key improvements

Researchers tracked real-world data from more than 140 patients who originally received a transcatheter heart valve from Edwards Lifesciences, Medtronic or Boston Scientific.

Abbott recalls heart device monitoring system due to malfunction risk

The new recall impacts thousands of portable systems. A software update is now available that should resolve any issues.

International experts issue new MRI-based prostate cancer screening guidance

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.

Bayer seeks FDA approval for gadoquatrane, its latest low-dose GBCA

The investigational agent uses 60% less gadolinium without sacrificing image quality, according to recent clinical trial findings.

Could the metaverse be the new radiology education classroom?

According to new data, the simulated virtual environment may be just as effective of a setting as the classroom for problem-based learning.

Statue of Liberty New York City healthcare

Late-breaking clinical trials announced for New York Valves 2025

The three-day event is now in its second year. Each day will feature late-breaking clinical trials focused on a different heart valve.

Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B

The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.

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Radiology Business

Factors making healthcare AI devices more likely to face recall

Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA.

Radiology Business

Oprah Winfrey blesses new CT scanner she helped fund in Hawaii

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.

Radiology Business

'Risk of electrical shock' prompts 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.