Allurion Technologies secured FDA PMA approval for its flagship gastric balloon system in early 2026, enabling U.S. commercialization of its non-surgical weight loss device. Simultaneously, the company faces critical risks with NYSE delisting proceedings triggered by insufficient equity and market capitalization. Liquidity constraints and ongoing net losses pose significant challenges to scaling commercialization efforts despite the promising regulatory endorsement. The firm’s near-term outlook hinges on capital raising success and execution of its FDA-approved product launch while navigating potential loss of major exchange listing.