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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.

Florida residents charged in Medicare fraud conspiracy said to involve 6,000 beneficiaries

The grand jury indicted two individuals for their alleged roles in a scheme to steal data on Medicare patients and re-sell that information for a premium to nefarious actors for the purpose of siphoning funds from the program. One of the individuals is accused of photographing patient records to obtain names, dates of birth and other personal information.

Portable PET/CT scanner guides bedside IR procedures

Though these treatments are typically done with assistance from real-time fluoroscopy, there is ample evidence nuclear imaging may offer more benefits.

6 opportunities to encourage wavering doctor trainees to chin up and soldier on

Last month saw the release of research showing a small but nontrivial number of physicians quit the job soon after completing residency training. Now comes a separate study suggesting the reasons for the phenomenon are often deep, diffuse and knotty—and thus difficult to address in a strictly programmatic way.

Siemens Healthineers receives $7M grant to spearhead cybersecurity research

Funding will back the imaging manufacturer's efforts to boost the cyber resilience of medical devices and equipment.

Around the web

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.