TGA Maintains Metal-On-Metal Hip Replacement Recommendations July 19, 2017 The TGA issued the statement in light of revised guidance by the U.K.’s Medicines and Healthcare products Regulatory Agency. Read More
CSA Medical’s trueFreeze Catheter Tech Wins Expanded 510(k) Approval July 18, 2017 The system is indicated for cryosurgery in dermatological, gynecological and general surgery procedures. Read More
CFDA Approves Gilupi CTC Device July 18, 2017 The CellCollector was the first in vivo CTC isolation device to secure the CE approval. Read More
FDA Approves Great Basin’s Pathogen Assay July 17, 2017 With the approval secured, the company plans to market the panel to more than 200 additional sites. Read More
FDA Clears Saebo’s Virtual Reality Rehab System July 17, 2017 The device can be personalized to alter coordination, timing, speed, endurance and range of motion. Read More
FDA Grants 510(k) Clearance to Royal Philips’ Wearable Psoriasis Treatment Device July 17, 2017 The wearable unit, aimed at treating mild psoriasis, is a Class II, home-use prescription device. Read More
Z-Medica Gets FDA Clearance for Internal Bleeding Control Device July 13, 2017 The device aids in stabilizing severely injured patients. Read More
Pinnacle Spine Group Receives a Fourth Patent for Graft Device July 12, 2017 The patent applies to the company’s system for delivery of graft material to the chamber of a spinal fusion device. Read More
Cerus Gets CE Mark for Intra-Cranial Aneurysm Device July 12, 2017 Cerus is currently conducting a 45-patient single-arm trial to demonstrate the device’s safety in treating unruptured aneurysms. Read More
FDA Reduces Clinical Trial Endpoint for Angioplasty Device July 11, 2017 The multi-center, single-arm study aims to investigate the safety and efficacy of Intact’s Tack device. Read More
Cardiologs Technologies’ ECG Analysis Platform Scores 510(k) Approval July 10, 2017 The platform uses cloud-based cardiac monitoring and analysis to analyze long-term ambulatory ECG monitoring recordings. Read More
Edwards Lifesciences Gets FDA Nod for Inspiris Resilia Valve July 7, 2017 The device is projected to hit the market in the U.S. early next year, according to the company. Read More