Health Canada Issues Updated Medical Device License To Align Technology For The Invisalign Palatal Expander System To Address Skeletal And Dental Expansion
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Health Canada has issued an updated medical device license for Align Technology, Inc.'s Invisalign Palatal Expander System, designed for skeletal and dental expansion in patients of various ages. The system, which includes Invisalign First aligners, offers a removable and clinically effective alternative to traditional palatal expanders. The product is currently available on a limited basis in Canada and is pending FDA 510(k) clearance in the U.S., with availability in other markets expected in 2024.
December 13, 2023 | 9:07 pm
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Align Technology's Invisalign Palatal Expander System received an updated medical device license from Health Canada, indicating progress in regulatory approvals and potential for increased market penetration in Canada and, upon FDA clearance, in the U.S.
The updated license from Health Canada for Align Technology's Invisalign Palatal Expander System suggests a positive regulatory development, which could lead to increased adoption and sales in Canada. The anticipation of FDA clearance and expansion into other markets in 2024 also presents potential for future growth. This news is likely to be viewed positively by investors, as it demonstrates progress in product development and market expansion efforts.
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