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The FDA is making significant organizational changes to the Center for Devices and Radiological Health (CDRH), which plays a lead role within the agency in how medical devices are evaluated or cleared for clinical investigations and marketing. Read More
“False-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals,” the agency said. Read More
Abbott reported that almost nine out of 10 patients treated with its TactiCath sensor-enabled (SE) ablation catheter for persistent atrial fibrillation (AFib) in a clinical study remained symptom-free up to 15 months later. Read More
Distinguishing between devices and drugs for regulatory purposes can be difficult in some cases, but the European Commission’s Medical Device Coordination Group (MDCG) has released a new guidance document that aims to help. Read More
Twenty minutes after treatment with either Nocira's device or a sham version, 60 percent of those treated with the genuine device had no pain vs. 7 percent of those treated with the placebo, the company said. Read More
Three device manufacturers reported positive study results for their products at the International Conference on Advanced Technologies and Treatments for Diabetes taking place this week in Barcelona, Spain. Read More