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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.

AI roundup: Platform vs. patchwork | The new workplace imbalance | Good-enough healthcare AI | more

2026 may be the year that many if not most healthcare leaders arrive at a fork in the road to mature AI implementation.

Nurse awarded $41M in wrongful termination lawsuit against Kaiser Permanente

The judgment includes $30 million in punitive damages. The lawsuit was brought by Maria Gatchalian, a NICU nurse who said she was fired for reporting patient safety concerns to management. The health system said it intends to appeal the court's decision.

Five practices agree to $6M settlement with DOJ as investigation into Medicare fraud scheme continues

The U.S. Department of Justice said the defendants, five ophthalmology clinics in Florida, would pay kickbacks to a testing company that performed unnecessary transcranial Doppler ultrasounds. Prosecutors said an investigation into incidents of Medicare and Medicaid fraud stemming from the conspiracy is ongoing.

‘Medicare for All’ bill proposed in Pennsylvania after ACA subsidies expire

The bill announced by two Democratic members of the state House of Representatives would guarantee coverage to everyone in the commonwealth—but many of the details have yet to be revealed.

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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.