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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. 

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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.

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. 

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The new recall impacts thousands of portable systems. A software update is now available that should resolve any issues. 

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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. 

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New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 

the words "FDA recall" on a board

The Class 2 recall pertains to the system's built-in shielding and collimation accessories. 

Abbott's Navitor TAVR valve

Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.

Recor Medical's Paradise Ultrasound Renal Denervation System

Recor Medical's Paradise Ultrasound Renal Denervation System is the first medical device approved for the treatment of hypertension in Japan. It first gained FDA approval back in 2023.

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.