FDA Issues Emergency Use Authorization for Centogene’s COVID-19 Assay July 6, 2020 The test is intended for use in the company’s high-complexity laboratories in Germany. Read More
Kardium Earns CE Mark for Globe Mapping and Ablation System July 2, 2020 Kardium has formed a subsidiary in Germany to handle commercial sales of the system in Europe. Read More
Kroger’s COVID-19 Test Home Collection Kit Cleared for Emergency Use July 2, 2020 The agency said promotional material for the home collection kit must make clear that it has not been FDA cleared or approved. Read More
Masimo Earns De Novo Classification for Opioid Withdrawal Device July 1, 2020 The device is applied to patients by a healthcare professional in a nonsurgical procedure. Read More
CoreLink’s 3D-Printed Cervical Spine System Cleared July 1, 2020 The device does not require a supplemental fixation plate, making the surgeries its used in simpler and faster. Read More
FDA Clears Orthofix’s Bone-Screw System for Sacroiliac Joint Dysfunction June 30, 2020 The system is implanted during a minimally invasive surgery that takes about an hour. Read More
Boston Scientific’s Insertable Cardiac Monitor Cleared June 30, 2020 The system uses an algorithm that detects and verifies potential arrhythmias and then sends an alert to clinicians. Read More
ContextVision Earns CE Mark for Prostate Screening Software June 30, 2020 The software can be used alone or alongside existing-picture archiving and communication systems. Read More
Beckman Coulter Snags Emergency Use Authorization for COVID-19 Antibody Test June 30, 2020 The serology test received CE mark certification earlier this month. Read More
Bioventus Bone Graft Strip Gains FDA 510(k) Clearance June 29, 2020 The company said it plans to launch the product in the U.S. in the third quarter. Read More
Pathofinder Launches Second COVID-19 Test June 29, 2020 The test runs on five of the most common real-time PCR instruments. Read More
Medtronic’s Brain Signal-Tracking Neurostimulation System Approved June 26, 2020 Physicians can use the device to deliver more personalized, data-driven neurostimulation treatment, the company said. Read More