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Despite Data Concerns, Panel Recommends First-In-Class Toe Implant

Cartiva, a toe implant to treat osteoarthritis, received a strong recommendation from a panel of FDA experts despite suggestions that the device had not fully proven itself.

An FDA panel has overwhelmingly voted to recommend approval of the Cartiva Inc.'s Cartiva synthetic cartilage toe implant despite strong reservations that the firm's data is relatively weak.

On April 20, the FDA's Orthopaedic and Rehabilitation Devices Panel voted 8-2 with two abstentions that the benefits of the implant outweigh the risks. The device, made from an organic...

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