AngioDynamics Submits 510(k) Application to FDA for AlphaVac Mechanical Thrombectomy System
Thrombectomy Device with Off-Circuit Mechanical Aspiration Design for Treatment of Undesirable Intravascular Material in Venous System and Peripheral Vasculature.AngioDynamics, Inc. (NASDAQ: ANGO), a leading...
Chemence Medical’s redesigned skin closure system approved by FDA
The US Food and Drug Administration (FDA) has granted 510(k) approval to Chemence Medical’s redesigned Exofin fusion skin closure system.The US Food and Drug Administration (FDA)...
Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis...
Digital X-ray company Nanox scores first FDA clearance
The company's device promises to change the way medical imaging is used and make it much more widely available by cutting the cost.Israeli imaging...
FDA grants Oxehealth Vital Signs De Novo clearance; Oxehealth launches in the US
Vision-based patient monitoring and management company will focus on skilled nursing facilities, where its technology service can help clinicians deliver safer, higher quality and...
Caristo Diagnostics announces EU approval for AI technology that can predict heart attacks years in advance
Research funded by us has led to EU-approved artificial intelligence (AI) technology that can identify people at high risk of a fatal heart attack...
FDA Grants Breakthrough Device Designation to Tempus’ Atrial Fibrillation ECG Analysis Platform, Developed in Collaboration With Geisinger
Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough...
GE Healthcare Gains FDA Clearance of New 3D Surgical Imaging
GE Healthcare was granted FDA 510(k) clearance to market OEC 3D, a new surgical imaging system capable of 3D and 2D imaging.This new system combines...
Medtronic secures CE mark for directional lead system for deep brain stimulation
Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed...