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Total artificial heart system gains entry to US FDA advisory programme - Cardiovascular News
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Total artificial heart system gains entry to US FDA advisory programme - Cardiovascular News
Bivacor has announced that its total artificial heart (TAH) system has been accepted into the US Food and Drug Administration’s (FDA) total product life cycle (TPLC) advisory programme—known as the TAP programme. The programme is designed to accelerate the development and patient access to high-impact medical technologies. Entry into the programme provides Bivacor with proactive, strategic engagement with the FDA throughout the entire product li…
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