Health Canada Clears Eclipse MicroPen Elite April 27, 2017 The device is to aid in the improvement of appearance of wrinkles. Read More
FDA Posts Evaluation Summaries for More Than 100 De Novo Devices April 27, 2017 There are two options for de novo classification for novel devices of low to moderate risk. Read More
MHRA Includes Device Regulatory Goals in Pre-Brexit Work Plan April 27, 2017 The MHRA is planning to propose a five-year plan encompassing national and international strategies for collaboration. Read More
Bausch + Lomb Wins FDA Clearance for Vitesse April 26, 2017 The device is a vitreous removal system. Read More
LimFlow Wins FDA Approval of IDE for Percutaneous Deep Vein Arterialization System April 26, 2017 The device is designed to bypass blocked arteries in the leg and deliver oxygenated blood to the foot. Read More
Bioness Receives CE Mark for the L300 Go System April 26, 2017 The device features 3D motion detection of gait events. Read More
Rivanna Medical Gains Health Canada Clearance for Accuro Spinal Navigation System April 26, 2017 The device received FDA clearance in 2015. Read More
Synaptive Medical Wins CE Mark and Approval in Australia for BrightMatter Plan April 25, 2017 The device software generates a 3D whole brain tractography. Read More
FDA Grants Clearance to Allergan’s TrueTear, the First Intranasal Neurostimulating Device April 25, 2017 The device is a handheld stimulator with daily disposable tips. Read More
AdvaMed Weighs in on Pre-Request for Designation Program April 25, 2017 The guidance lays out the content and format sponsors will be expected to follow. Read More
Cures Act Leaves Combination Product Issues Unresolved April 25, 2017 In almost every case, a combination product involving a chemical action is automatically referred to CDER. Read More
Millennium Medical Technologies Wins FDA Clearance for a Reusable Fat Collection and Grafting System April 24, 2017 The device system is indicated for use of fat grafting to the breast, buttock or large volume contouring. Read More