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FDA recall medical device recall product recall

The issue, first announced to the public in February, has been linked to 22 serious injuries. Customers are urged to review the updated instructions for use to avoid any potential complications. 

Cereglide 57 image courtesy of Johnson & Johnson MedTech.

These devices were developed to help clinicians reach and remove distal clots associated with significant pain and swelling. If left untreated, such clots can lead to medical emergencies and even death.

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The petition from Harrison.ai has drawn mixed reactions, with AI vendors lending support while radiologists and patient groups worry the move could erode safety. 

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The Los Angeles-based imaging group believes the move will make its DeepHealth subsidiary the “largest provider of radiology clinical AI solutions worldwide.” 

Shine Technologies

Surgeon, researcher and billionaire entrepreneur Patrick Soon-Shiong, MD, and his company NantWorks led the funding round with participation from several others.

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The National Security Agency released a two-phase plan for all entities within the U.S. Department of War to follow for no-trust cyber defenses. The American Hospital Association said the protocols could be adopted by hospitals.

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The study by the nonprofit KFF is focused on the jump in overall healthcare prices from 2022 to 2024, with hospitals leading as a result of both delayed care from the pandemic and an increase in prices for services.

Abbott has secured U.S. Food and Drug Administration (FDA) approval for its CardioMEMS HERO device, a next-generation pulmonary artery (PA) pressure reader for heart failure patients.

The updated reader is 60% smaller and offers built-in WiFi connectivity. It works with an implantable sensor to monitor a patient's PA pressure. 

MRI accident prompts questions on safety

Researchers from the University of Houston caution that certain implanted electrode cuffs could cause inadvertent stimulation of the nerves during MRI scans. 

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MiniMed, Medtronic's diabetes business, hopes to sell 28 million shares of its common stock at a price of $25 to $28 per share.

Friederike Keating, MD, professor of medicine at the Larner College of Medicine, and director of nuclear cardiology at University of Vermont Health, said artificial intelligence (AI) in medical imaging may actually increase costs and make workflows less efficient in some instances. She said this is a key thing for health systems and policy makers to keep in mind if there is not clear data showing it helps.

AI has shown the potential to transform patient care. However, there are more details to consider than many health systems and policymakers realize. 

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Officials are examining how a radiologist's CT findings may have played a part in the untimely death, as the doctor did not notate "swirling of the mesentery" in his interpretation. 

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The issue, first announced to the public in February, has been linked to 22 serious injuries. Customers are urged to review the updated instructions for use to avoid any potential complications.