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Bard loses appeal of US lawsuit after judge in jury trial disallows evidence of 510(k)

U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial. ....

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The Potential Moat Of OpenAI - How OpenAI Can Secure Its Investments

OpenAI is focused on the right area to create a moat and protect their R&D: User Experience, Data Feedback Loop, Workflow Integration, Data Access, Regulatory Support. ....

Derik Schmidt , Guido Appenzeller , Sam Altman , Language Models , Large Language , Once Openai , Data Will Change , World Power , User Experience , Data Access , Workflow Integration , R Amp D , Data Feedback ,

Angiovac gains breakthrough device designation for vegetation removal

Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations masses of fibrin, platelets and infectious pathogens are indications of serious infective endocarditis. ....

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