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
HPRA Issues Guidance on Device Standalone Software July 5, 2017 The software is considered an active medical device, the guide notes, so it must be assigned one of the HPRA’s four risk classifications. Read More
ConforMIS Hip Replacement System Scores 510(k) Clearance June 29, 2017 The system uses single-use 3D-printed instruments in combination with patient-specific technology. Read More
LiveNova’s Epilepsy Device Gets Expanded Approval for Use With MRIs June 29, 2017 Under the expanded access, the AspireHC and AspireSR models can now be used with MRIs. Read More