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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.

Express Scripts sues Tennessee over PBM law that would close specialty pharmacy

The company called the state’s regulation of pharmacy benefit managers “shortsighted,” as it would force the closure of Accredo, a specialty drug dispensary that supplies drugs it says aren’t available anywhere else in the state.

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.

Prompt engineering experts' brains are wired differently

The brains of expert AI prompt engineers really are wired differently

Mastering the art of effective prompts has become a coveted skill in the fast-growing field of AI.

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

Medtronic receives updated FDA approval for redo TAVR

The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.

CDC director, chief medical officer ousted as RFK shakes up agency

CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”

Radiology practice sells imaging center to hospital partner while remaining independent

Fayetteville-based Valley Regional Imaging is unloading its facility to Cape Fear Valley Health, a hospital based in the same Sandhills-region community of southeastern North Carolina.

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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.