FDA and the company could not come up with a plan to continue the ENDO study for GI's device targeting obese patients with diabetes in response to higher-than-anticipated rates of liver infection. The company suggests, however, that development of the device will continue.
GI Dynamics Inc. is shutting down the U.S. pivotal trial for its Endobarrier device for obese patients with diabetes after talks with FDA failed to yield a plan for addressing elevated rates of liver infection in the trial. But the company suggests development of the product will continue.
The July 30 announcement that the ENDO trial is being terminated comes almost five months after the company disclosed that...
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.
For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.
