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Long Bridge Medical Receives Clearance from FDA to Initiate the U.S. Pivotal Clinical Study for LensOne Prosthetic Capsular Bag [Yahoo! Finance]

Oracle Corporation (ORCL) 
Last oracle corporation earnings: 3/12 04:02 pm Check Earnings Report
Company Research Source: Yahoo! Finance
SOUTH SAN FRANCISCO, Calif., March 26, 2026 BUSINESS WIRE )--Long Bridge Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared initiation of its Investigational Device Exemption (IDE) study for LensOne™, the company's prosthetic capsular bag designed to enable reliable secondary intraocular lens (IOL) fixation in patients with absent or compromised lens capsule support in poor candidates for anterior chamber intraocular lenses (ACIOL). The approval of the IDE application enables initiation of the GOLDEN GATE pivotal trial, a prospective, multicenter study evaluating the safety and effectiveness of LensOne in patients with IOL dislocation who are poor candidates for ACIOL. The clearance builds on Long Bridge Medical's previously granted FDA Breakthrough Device Designation, which recognized the device's potential to address a significant unmet need in a patient population with no FDA-approved surgical options. Tens of thousands of patients in th Show less Read more
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