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artificial intelligence

Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA. 

oprah-at-ct-scanner-blessing-with-kahu-kimokeo-and-imaging-director-kelly-combs_web-1024x682.jpeg

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. 

FDA issues 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. 

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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.

Nashville Tennessee

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

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.

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.

Sapien 3 Ultra Resilia TAVR valves

Researchers tracked real-world data from more than 140 patients who originally received a transcatheter heart valve from Edwards Lifesciences, Medtronic or Boston Scientific. 

The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.

More research is still needed, as this study only included data from a small number of patients, but TAVR was not linked to any severe adverse events or allergic reactions.

warning safety alert recall healthcare issue

The system enables surgeons to intraoperatively illuminate cancerous tissue in the breast cavity during lumpectomy surgery.

Joshua M. Hare, MD, FACC, FAHA, a professor of medicine, molecular and cellular pharmacology, and biomedical engineering, director of regenerative medicine, and director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami, and co-founder and chief science officer for the stem cell start-up Longeveron, explains the FDA trial for laromestrocel (Lomecel-B) to treat hypoplastic left heart syndrome (HLHS).

The new trial represents a potential breakthrough in the treatment of one of the most devastating congenital heart defects.

As mitral transcatheter edge-to-edge repair continues to gain momentum in the United States, a new study of CMS data examines what happens to patient outcomes when the procedure fails.

Around the web

Deviations from a device’s intended use most often trigger FDA recalls, “highlighting unique safety challenges” in AI, experts write June 11 in JAMA. 

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. 

A handful of fluoroscopy units manufactured by GE HealthCare are the subject of a new recall by the U.S. Food and Drug Administration.