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The single-use device allows surgeons to view all the sinus space and to visualize anatomic landmarks up close during and after surgeries, the company said. Read More
AcQMap 8 includes new mapping algorithms that are designed to quickly highlight regions of interest during the mapping and ablation of complex atrial arrhythmias. Read More
The FDA cited reports of “endcap separation, O-ring seal failure and potential exposure of internal components of this device to living tissue that may lead to adverse local tissue reactions” in Magec devices. Read More
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021. Read More
An FDA advisory committee concluded that Keystone Heart’s Triguard 3 cerebral embolic protection device is not substantially equivalent to a predicate device. Read More
The EU’s Medical Device Coordination Group (MDCG) released guidance on evaluating the performance of in vitro diagnostics that detect SARS-CoV-2 nucleic acid, antigens and that quantify antibodies. Read More
Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More