FDA Clears Gynesonics’ Sonata System for Treating Uterine Fibroids August 23, 2018 The Sonata system provides transcervical treatment for uterine fibroids that requires no incisions. Read More
Gore Gets 510(k) Clearance of Molding and Occlusion Balloon August 23, 2018 The device is designed to help clinicians with the expansion of stent grafts and the temporary occlusion of large-diameter vessels. Read More
UVision360’s Hysteroscopy System Receives 510(k) Clearance August 22, 2018 Physicians can use the system to perform the procedures in their offices. Read More
FDA Clears TechLab’s Gastrointestinal Diagnostic Tests August 22, 2018 The QuikChek test can diagnose infection in 30 minutes. Read More
FDA Clears Dual-Lead Nerve Stimulator for Pain Relief August 21, 2018 The stimulator comes with a wearable electronic pulse generator and a Bluetooth compatible remote. Read More
Kleresca Approved in EU for Dermatological Platform August 21, 2018 The treatment does not damage the skin’s natural barriers. Read More
TPlus Receives CE Mark for Medical Image Archiver August 21, 2018 The device generates only integral images for diagnosis and has removed its less frequently used functions. Read More
FDA Clears First App for Contraceptive Use August 20, 2018 Subsequent devices with the same intended use would go through the FDA’s 510(k) process. Read More
FDA Allows Marketing of Brainsway’s TMS for OCD Treatment August 17, 2018 The agency said the device should not be used by patients with metallic objects or implants that are in or near the head. Read More
CoreLink’s 3D Anterior Lumbar Approved by FDA August 17, 2018 The implant allows for better imaging by minimizing material density. Read More
Implantica Receives CE Mark for RefluxStop August 17, 2018 The device avoids potential complications that arise from compressing the food passageway. Read More
Zavation Launches FDA Approved Screw Systems August 16, 2018 The system is used to stabilize the sacroiliac joint. Read More