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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.

Signs of Alzheimer's evident on imaging up to 15 years prior to symptom onset in Down syndrome population

By identifying these structural changes prior to the onset of symptomatic neurodegeneration, providers may be able to initiate preventive therapies sooner.

artificial intelligence AI explainable ethical responsible

‘Life or death consequences’: AMA pushes for greater transparency in imaging AI

The American Medical Association passed a resolution at its recent annual meeting seeking to “maximize trust” around how these models reach conclusions.

Bristol Myers Squibb will pay $350M-plus to add prostate cancer imaging agent

Subsidiary RayzeBio has inked a definitive deal to license the worldwide rights for the drug from Philochem, a Swiss biotechnology firm.

healthcare insurance fraud scam scheme legal lawsuit

Fraud prevention expert charged with over 167 suspected incidents of healthcare fraud

Faranak Firozan, 47, is a cybersecurity expert at Nvidia who regularly spoke on the topic of “cyber laundering.” Prosecutors in California allege she submitted fraudulent medical claims to an employer-sponsored insurance plan, bilking Cigna out of $100,000.

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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.