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FDA IDE

PharmaDeviceNews FDA IDE
Representative image of a clinician reviewing implantable glucose sensor technology and digital blood glucose trends, as Glucotrack seeks FDA approval to begin a U.S. clinical study of its continuous blood glucose monitoring system.
Medical Devices & Diagnostics

Why Glucotrack’s CBGM filing could test the next frontier in diabetes monitoring

Wearable CGMs dominate diabetes care. Glucotrack’s implantable CBGM now faces the harder FDA test: durable blood-based proof.

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Representative image of complex eye surgery illustrating secondary intraocular lens fixation, as Long Bridge Medical advances the LensOne prosthetic capsular bag into an FDA-cleared pivotal trial that could reshape treatment options for patients with compromised capsular support.
Medical Devices & Diagnostics

LensOne enters pivotal study as Long Bridge Medical targets a difficult gap in secondary IOL fixation

Long Bridge Medical’s LensOne has entered a pivotal FDA-cleared study. Read why this ophthalmic device trial could reshape secondary IOL fixation.

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Medical Devices & Diagnostics

What EndoQuest’s PARADIGM Trial approval reveals about robotic ESD innovation in GI surgery

EndoQuest wins FDA approval to complete PARADIGM Trial for its ELS system. Find out what this milestone means for robotic GI surgery innovation.

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