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
KinetiCor’s Motion Correction System Cleared February 19, 2020 The image correction system is used for maintaining image clearness when patients move their heads during neurological MRIs. Read More
Novacyt Nabs CE Mark for COVID-19 Diagnostic February 19, 2020 The company previously launched a research-use-only test for the novel coronavirus on January 31. Read More
NICE Recommends Wireless Overactive Bladder Treatment February 18, 2020 The system includes a handheld remote control to apply stimulation and adjust the level. Read More