SpeeDx Gains CE Mark for Gonorrhea Test December 6, 2018 The assay provides information on the disease’s antibiotic susceptibility. Read More
FDA Clears Bausch + Lomb’s Multifocal Toric Lens December 6, 2018 Patients can be immediately fitted with a diagnostic version of the newly approved contact lenses. Read More
Subtle Medical Cleared for AI-Powered Imaging Tech December 6, 2018 The technology increases the number of scans health care professionals can run each day. Read More
FDA Clears Posterior Cervical Thoracic Spine System December 5, 2018 The system is designed to link with Nexxt Spine’s Inertia pedicle screw system. Read More
Asuragen’s DM1 Assay Gets CE Mark December 4, 2018 The kit includes reagents to accurately measure every expansion of the disease using as little as 20 nanograms of DNA. Read More
Diabetes Management System Earns CE Mark December 4, 2018 It is the second CE Mark for an artificial pancreas-like device. Read More
FDA OK’s Test for Herpes Virus in Newborns December 3, 2018 The test detects the virus DNA from a saliva swab. Read More
Aziyo’s Bioscaffold Cleared by FDA for Expanded Use November 30, 2018 The bioscaffold can reduce device migration and make device removal easier for exchanges or revisions. Read More
Quidel Gains CE Mark for High-Sensitivity Troponin I Test November 30, 2018 The test uses whole blood or plasma samples that have been anticoagulated on Quidel’s Triage Meter Pro device. Read More
ElectroCore’s Nerve Stimulator Receives Expanded Clearance for Treating Cluster Headaches November 29, 2018 The device is the only product cleared by the FDA for prevention of cluster headache. Read More
Varian’s Cancer Treatment System Receives Chinese Approval November 29, 2018 The image-guided radiotherapy offers advanced treatments for lung, breast, prostate, head, neck and other forms of cancer. Read More
OrthoXel Cleared for Femoral Nailing System in Europe November 28, 2018 The system can also provide rigid interlocking used for unstable femur fractures. Read More