CeGaT Earns CE Mark for Coronavirus Antibody Test May 13, 2020 The blood test is more than 95 percent accurate for positive samples and almost 99 percent accurate for negative samples, Read More
Abbott Receives Emergency Use Authorization for COVID-19 Test May 13, 2020 The company is currently launching the Alinity m analyzer. Read More
Somnetics Cleared by FDA to Distribute Non-Invasive Ventilators May 13, 2020 The non-invasive devices place less stress on patients. Read More
Quidel Gets Emergency Clearance for COVID-19 Diagnostic May 12, 2020 Quidel’s immunoassay analyzer delivers test results in 15 minutes. Read More
Pixee’s Orthopedic Navigation System Gains CE Mark for Knee Surgery May 11, 2020 Pixee also plans to seek certification for the augmented reality system for use in shoulder surgery. Read More
Accure Receives CE Mark for Acne Laser Device May 11, 2020 Accure plans to launch the system in Europe later this year. Read More
Grifols’ Automated Blood-Screening Platform Cleared May 8, 2020 Laboratories can select different configurations based on their needs. Read More
Headsafe Earns FDA Clearance for Brain-Assessment System May 8, 2020 The collected data is sent to a smartphone app. Read More
Biomerica Gets CE Mark for High-Volume Version of COVID Diagnostic May 8, 2020 The company shipped a previous version of the test for distribution to NATO and multiple countries. Read More
BGI Genomics’ COVID-19 Test Gets Canadian Authorization May 8, 2020 The company said it can manufacture 2 million tests per day. Read More
FX Gets FDA Clearance for Shoulder Replacement Cups May 7, 2020 The shoulder stability cups will be available in a range of sizes. Read More
LifeSignals’ ECG Monitoring Patch Gets CE Mark May 7, 2020 The wireless patch can be used with other remote patient monitoring systems, the company said. Read More