PenBlade
Author: Nova Szoka, MD PenBlade by PenBlade, Inc. is registered as a Class 1 device with the FDA – registration number 3010780223. PenBlade is a single-use safety scalpel with a retractable steel blade. The device activates like a click pen and retracts via a separate button near the front of the handle, allowing the user […]
Hemospray™
Author: David Pechman, MD Cook Medical received FDA approval for Hemospray on May 7, 2018. HemosprayTM is a proprietary mineral powder that can be administered endoscopically and promotes hemostasis. The powder, inorganic and inert, forms an adhesive layer when it comes into contact with fluid. The adhesive layer provides mechanical compression and promotes hemostasis. In […]
EnVisio™ Navigation System
Authors: Marguerite Ballou, MD; Nova Szoka, MD Elucent Medical received FDA approval for the EnVisio™ Navigation System on March 22, 2019. The EnVisio™ Navigation System is a technology that detects the presence of a SmartClip™ Soft Tissue Marker using an electromagnetic localization system. The SmartClip™ is a permanent marker inserted percutaneously at a biopsy site […]
symphonX™ Surgical Platform
Author: Eugene Cho, MD FortiMedix received FDA approval for the symphonX™ (FMX314) Surgical Platform on August 26, 2016. The symphonX™ surgical platform provides a path of entry for laparoscopic instruments and camera through a single site and allows for triangulation similar to standard laparoscopy. The device fits through a standard 15-mm trocar and has 4 channels, […]
TransEnterix Senhance Ultrasonic System
Authors: Gustavo Romero-Velez, MD; David M Pechman, MD TransEnterix received FDA approval for Senhance Ultrasonic System on January 15, 2019. The Senhance Ultrasonic System is an advanced energy device that couples with Senhance robotic surgery platform. With the Senhance Surgical System, TransEnterix strives to improve minimally invasive surgery by digitizing the interface between the surgeon […]