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The FDA offers recommendations on nonclinical assessments of containment systems used with laparoscopic power morcellators (LPMs) — including testing for permeability, burst strength and leakage — in a new draft guidance. Read More
A new study evaluating Cardiologs’ deep learning tool for identifying patients at risk for atrial fibrillation (AFib) showed that it outperformed regular 12-lead electrocardiogram (ECG) testing. Read More
Due to its ability to differentiate between natural and vaccine-based antibodies, the PictArray test could help in future vaccine development, the company said. Read More
GI Dynamics’ announced final data from a multisite clinical study of its experimental EndoBarrier system, saying it met its endpoints in glycemic control efficacy and serious adverse events (SAE). Data also show clinically significant weight loss, the Boston-based company said. Read More