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Bard Peripheral Vascular Rotarex Atherectomy System recall

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

california usa

California has moved assertively to legislate guardrails around AI in healthcare. Will other states follow? 

agentic AI agents in healthcare

Healthcare AI agents can be classified as one of four models. In increasing order of autonomy and clinical integration, these are: foundation, assistant, partner and pioneer. 

The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury. 

Special needs child

Motivity is receiving an injection of cash from Five Elms Capital, a software investment firm. The companies said the funds will be used to hire staff and improve products.  

Product Recall

There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall. 

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More than 33,000 devices are affected by this recall. Customers may need to return and replace the purge cassettes included with their devices due to a risk of serious injury or death.