InspireMD Has Submitted A Premarket Approval Application To FDA Seeking Approval For The CGuard Prime Carotid Stent System, US Commercial Launch Anticipated In H1 2025, If Approved
Portfolio Pulse from Benzinga Newsdesk
InspireMD has submitted a premarket approval application to the FDA for its CGuard Prime Carotid Stent System. If approved, the company anticipates a US commercial launch in the first half of 2025.
September 16, 2024 | 11:05 am
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InspireMD has applied for FDA approval for its CGuard Prime Carotid Stent System, with a potential US launch in H1 2025. This regulatory step is crucial for market entry.
The submission of a premarket approval application to the FDA is a significant step for InspireMD, as it could lead to the introduction of their product in the US market. Approval would likely boost the company's market presence and revenue potential, positively impacting the stock price.
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