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www.fdanews.com/articles/211049-aspivixs-carevix-cleared-to-reduce-pain-bleeding-in-gynecological-procedures

Aspivix’s Carevix Cleared to Reduce Pain, Bleeding in Gynecological Procedures

February 6, 2023

The FDA has granted 510(k) marketing clearance to Aspivix’s Carevix for use in gynecological procedures such as insertion of an intrauterine device.

The device replaces a cervical tenaculum, which has sharp points, with soft suction to gently stabilize the cervix, reducing pain and bleeding.

Participants in a study reported up to 73 percent less pain and 78 percent fewer bleeding occurrences.

Lausanne, Switzerland-based Aspivix is focused on developing innovative gynecological devices to improve women's healthcare.

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