Approvals

FDA Approves Marketing of Allergan’s True Tear Device

The FDA has approved marketing of Allergan’s True Tear intranasal tear neuro-stimulator device. The handheld device was picked up in Allergan’s 2015 acquisition of Oculeve.

Bioness Wins EU Approval for L300 Go

Rehabilitation device maker Bioness, Valencia, Calif., announced CE Mark approval for its L300 Go functional electrical stimulation system. The company says it is the first such system to offer comprehensive 3D motion detection of gait events from a 3-axis gyroscope and accelerometer.

Intuitive Surgical Gets EU Approval for daVinci X Surgical System

Intuitive Surgical, Sunnyvale, Calif., a maker of robotic-assisted, minimally invasive surgery devices, has  received CE Mark approval in Europe for its da Vinci X Surgical System.

GenMark Secures Updated CE Mark for its ePlex

California–based Genmark has secured an updated CE mark or its ePlex blood culture identification fungal pathogen panel. The ePlex systems support a broad range of molecular diagnostic tests with a compact workstation and disposable test cartridges.

FDA Grants Marketing Clearance to Cardiac Insight’s Wearable ECG Sensor

Washington–based Cardiac Insight has gained FDA marketing clearance for its Cardea Solo wearable electrocardiogram sensor. The device is used to assist in the diagnosis of a variety of arrhythmias by recording ECG data and patient symptoms.

Millennium Medical Wins FDA Clearance for Fat Collection and Grafting System

California–based Millennium Medical Technologies has received FDA marketing clearance for its Lipo-Loop system which is a reusable fat collection and transfer system for plastic or reconstructive surgery.

Synaptive Medical Wins CE Mark and Approval in Australia for BrightMatter Plan

Toronto–based Synaptive Medical has received a CE Mark in Europe as well as regulatory approval in Australia for its BrightMatter Plan neurosurgical planning system.

Rivanna Gains Health Canada Clearance for Accuro Spinal Navigation System

Virginia–based Rivanna Medical received Health Canada marketing clearance for its Accuro automatic spinal navigation system for epidural and related neuroaxial anesthesia guidance. The device received FDA clearance in 2015. It will be launched in Canada in May.

LimFlow Wins FDA Approval of IDE for Deep Vein Arterialization System

LimFlow has gained FDA approval for its investigational device exemption for a feasibility study of the percutaneous deep vein arterialization system. The LimFlow system received a CE Mark in October 2016 and is currently available in Europe.

Bausch + Lomb Wins FDA Clearance for Vitesse

Bausch + Lomb has received FDA marketing clearance for Vitesse, a hypersonic device for vitreous removal that uses a single-needle design.