FDA Clears LivaNova’s Modification to Heater-Cooler Device February 26, 2020 The heating and cooling device is designed to meet the temperature needs of patients undergoing cardiac surgery. Read More
Zynex Earns FDA Clearance for Blood Volume Monitor February 25, 2020 The device measures six independent parameters. Read More
Kurin’s Push-Button Needle Tech Cleared by FDA February 25, 2020 “Kurin’s patented automatic blood discard product is the only FDA 510(k) cleared blood culture product in its class,” the company said. Read More
Co-Diagnostics’ Coronavirus Test Earns CE Mark February 25, 2020 “We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD,” the company’s CEO said. Read More
Fist Assist Devices Earns CE Mark for Vein Compression Device February 24, 2020 The device is used in AV fistula placement and phlebotomy procedures and has not yet received FDA clearance. Read More
First Genetic Test for Fragile X Syndrome Cleared February 24, 2020 The syndrome can cause learning disabilities, delays in development, intellectual disabilities, autism and social/behavioral issues. Read More
FDA Hands Breakthrough Device Status to Cardiovalve’s Valve Replacement System February 21, 2020 The device can be used by 90 percent of the patient population, the company said. Read More
Biotronik Earns CE Mark for Drug-Eluting Stent February 21, 2020 The stent system improves coronary luminal diameter in patients with symptomatic ischemic heart disease. Read More
Canon Receives 510(k) Clearance for AI-Assisted CT System February 21, 2020 The device “uses deep learning to distinguish true signal from noise,” the company said. Read More
Paragon 28’s Plantar Plate Repair System Earns 510(k) Clearance February 20, 2020 The suture implant contracts and forms a flat anchor that keeps it from pulling out. Read More
Dexcom’s Continuous Glucose Monitoring System Grabs CE Mark February 20, 2020 Continuous glucose monitoring is important for pregnant diabetic patients, who experience difficulties in glucose management. Read More
Abbott Grabs CE Mark for Remotely Monitored Defibrillators February 19, 2020 The devices enable physicians to monitor patients remotely. Read More