Device launch, certification, approvals

Departments - Regulatory

Zavation Medical Products’ eZspand; Vision Engineering attained ISO 17025:2017; Breakthrough Device designation

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Device launch

Zavation Medical Products’ eZspand expandable lumbar interbody fusion- device provides a precise, continual expansion optimized fit for each patient, enhancing structural stability and improving sagittal balance. The device does not require secondary locking, minimizing procedural steps. Each implant expands to 4.5mm from the insertion height to create a large graft window that facilitates fusion. https://zavation.com

Certification

Vision Engineering attained ISO 17025:2017 accreditation and is now a UKAS-accredited calibration laboratory, No. 7706. The Vision Engineering temperature-controlled facility is certified for calibration of measurement stages, instrumentation, and artifacts performed at Vision’s high-tech manufacturing complex in Surrey, UK. https://www.visioneng.us

APPROVALS, CLEARANCES, DESIGNATIONS

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to Neurolief’s RelivionDP system designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults. The neurostimulation device is placed on the head, stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with mood control. Three adaptive output channels transfer mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves. RelivionDP is used in tandem with a smartphone app and cloud database for remote monitoring, data analysis, and personalized treatments. https://www.neurolief.com

Germany-based joimax’s electromagnetic Intracs Navigation Tracking & Control System received FDA approval, enabling spinal procedures with reduced radiation, access time, and procedure length. All joimax instruments and scopes can be tracked and accurately navigated through the appropriate sensors, improving safety, expanding endoscopic indications, and flattening the learning curve. https://www.joimax.com