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Regulatory milestones for FDA/CE pathways in medtech historically lead to multiple expansion when milestones reduce regulatory risk and improve revenue visibility; positive ISO 13485 and MDR progress may attract buyers in PFSA stock, especially if CE marking proceeds closer to expectations.
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Profusa reported GMED’s positive ISO 13485 certification, advancing MDR conformity for the Lumee Oxygen Platform toward CE marking. Timing for the MDR assessment and CE approval remains uncertain, but completion would enable EU market access and potential revenue growth from tissue oxygen monitoring. The firm also cited an option to acquire G3 Vision Labs, signaling strategic expansion.
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