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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.

Optum UnitedHealthcare UnitedHealth Group HQ

FTC settles lawsuit with Optum Rx, ending its campaign against the ‘big three’ PBMs

The agency had been suing the three largest pharmacy benefit managers over their alleged control of insulin prices. It reached agreements with CVS’ Caremark and Cigna’s Express Scripts earlier this year.

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.

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.

New ABC campaign works to improve care in cardiology deserts

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

Medical societies, medtech companies and clinicians weigh in as CMS considers sweeping TAVR changes

CMS is considering substantial updates to its TAVR policies, including coverage for asymptomatic patients. Some stakeholders are excited, embracing the possibility of expanded indications and fewer restrictions. Others are concerned that the changes would be too much, too soon.

High-level briefing: Rural healthcare downs & ups | Healthcare affordability in focus | Viruses to watch like a hawk in 2026 | more

Where have the missing rural American hospitals gone? And where is rural healthcare headed? The discussion is on in Washington and elsewhere.

31K Kaiser Permanente employees prepare to strike, citing staffing issues and low pay

The health system said it offered a “historic” 21.5% raise as part of a new contract, but it’s been unable to reach an agreement with union officials. Workers are expected to walk off the job starting Jan. 26.

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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.