Establishment Labs Says FDA Granted 510(k) Clearance For The Motiva Flora SmoothSilk Tissue Expander
Portfolio Pulse from Benzinga Newsdesk
The FDA has granted 510(k) clearance to Establishment Labs for its Motiva Flora SmoothSilk Tissue Expander. This makes Flora the only magnet-free and MR Conditional tissue expander cleared for the U.S. market.
October 16, 2023 | 10:03 am
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Establishment Labs has received FDA 510(k) clearance for its Motiva Flora SmoothSilk Tissue Expander, making it the only product of its kind in the U.S. market.
The FDA clearance of Establishment Labs' Motiva Flora SmoothSilk Tissue Expander is a significant regulatory milestone for the company. This approval not only validates the safety and effectiveness of the product but also gives it a unique position in the U.S. market as the only magnet-free and MR Conditional tissue expander. This could potentially lead to increased sales and market share, positively impacting the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100