DiaSorin Earns CE Mark for Testosterone Test August 10, 2020 The company said the test, which is intended for in vitro diagnostic use, has been launched in Europe with receipt of a CE mark. Read More
FDA Authorizes Vela’s COVID-19 PCR Test for Emergency Use August 10, 2020 The test has earned a CE mark in Europe and a provisional approval in Singapore. Read More
Siemens Healthineers’ Bedside CT Head Scan System Cleared August 7, 2020 The system includes accessories to help position patients correctly for scanning. Read More
FDA Clears Surmodics’ Dilatation Catheter August 7, 2020 The device has the longest working length of any FDA-cleared dilatation catheter, the company said. Read More
NeuMoDx Gets CE Mark for Quantitative BK Virus Assay August 7, 2020 The freeze-dried assay is stable at room temperature for two years. Read More
Life Spine Gets FDA Clearance for Lumbar Spacer August 7, 2020 The implant is available in multiple sizes and heights. Read More
Abbott Begins Trial of TactiFlex Ablation Catheter August 6, 2020 The catheter features sensors that help physicians to navigate with improved accuracy during heart surgeries. Read More
Medtronic Micro Neurostimulator Cleared August 6, 2020 The rechargeable device reduces the need for battery replacement surgeries. Read More
Endologix’s Abdominal Stent Graft CE Marked August 6, 2020 Endologix has already launched the system in the U.S. and is expanding the launch in Europe and beyond. Read More
FDA Clears Eyenuk’s Diabetic Retinopathy Screening System August 6, 2020 The technology was tested on more than 500,000 patients. Read More
Bentley Nabs CE Mark for Venous Self-Expanding Stent August 5, 2020 The company said it will initially offer the product for use by leading venous experts, followed by a full launch early next year. Read More
FDA Clears Abiomed’s Impella Heart Pumps for Emergency Use August 5, 2020 The pumps received a premarket approval from the FDA in 2015. Read More