Elekta Nabs FDA Clearance for Venezia February 2, 2017 The device received a CE mark in November 2016. Read More
Medtronic’s CardioInsight Mapping Solution Receives FDA Clearance February 2, 2017 The device maps out the heart by collecting electrocardiogram signals. Read More
FDA Grants Abbott Marketing Clearance for Zika Virus Test February 2, 2017 The Abbott real-time Zika test is designed for use on the m2000 real-time system. Read More
FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update February 2, 2017 The device is indicated for use in patients with suboptimal echocardiograms. Read More
FDA Expands Clearance for Brain Surgery Technology February 1, 2017 The agency has expanded the indication for two brain surgery devices. Read More
EU Expands CE Mark Indication for Agilent Technologies’ Dako Companion Diagnostics February 1, 2017 The device allows for detection in all patients. Read More
Abbott Gains FDA Approval for its Assurity MRI Pacemaker February 1, 2017 The devices are not affected by MRI scans. Read More
UK’s NICE Recommends Use of SecureAcath January 31, 2017 The device is used to affix PICCs to the skin. Read More
Illumina Receives CE Mark to VeriSeq Analysis Software January 31, 2017 The software includes a method for processing samples and is designed for larger batches. Read More
Medtronic Gains CE Mark for Lower Profile HawkOne 6F Directional Atherectomy System January 31, 2017 The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. Read More
DePuy Synthes Gains FDA Clearance for Two Cement-Augmented Pedicle Screw Systems January 26, 2017 The systems may be used in spinal fusion surgery. Read More
FDA Grants Clearance to GEO Bone Screw System January 26, 2017 The device is for single-use only. Read More