FDA, Industry Seek Better Computer Models For Cardio Device Development
FDA wants to better understand computer modeling methods - such as programs that simulate the performance of heart valves in the body - and help companies incorporate such tests into pre-market device applications
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
Ketryx relies on a combination of continuous validation, testing, and human oversight to ensure the platform remains compliant and reliable as AI capabilities evolve, CEO Kaminski said.