The HistoSonics Edison System was approved by the U.S. Food and Drug Administration (FDA) through the De Novo pathway 513(f)(2) on October 6, 2023. Because there are no other substantially equivalent devices, the De Novo 513(f)(2), rather than the 510(k) approval pathway, was required. The FDA classifies the Edison generally, as a focused ultrasound system […]
da Vinci 5
Device Name: da Vinci 5 Author(s): Jamie Benson, MD, and Matthew D. Burstein, MD, PhD, FACS, DABOM Intuitive Surgical, Inc received FDA approval for da Vinci Surgical System Model IS5000, along with da Vinci Insufflator and Tube Set with Smoke Evacuation, more commonly known as together as “da Vinci 5” or “da Vinci Gen 5”on […]
MIRA Surgical System
Device Name: MIRA Surgical System Author(s): Andrew Luhrs, MD Virtual Incision received FDA authorization for MIRA Surgical System on February 23, 2022. MIRA is a table mounted miniaturized robotic-assisted surgery (RAS) platform. Its form factor is designed to offer the benefits of RAS during colectomy while seeking to minimize the logistical inefficiencies of traditional RAS […]
LIQUIFIX™ Open and Laparoscopic Hernia Mesh Fixation Devices
Authors: Joseph Talbet MD, David Pechman MD Advanced Medical Solutions (Winsford, U.K.) received FDA approval for both the LIQUIFIX™ Precision Open Hernia Mesh Fixation (HMF) Device and LIQUIFIX FIX8® HMF Device on June 2, 2023. The LIQUIFIX™ Precision Open HMF Device is intended for the use in open surgical repair of inguinal and ventral hernias; […]
Stryker 1788 4K Camera System with Advanced Imaging Modality by Stryker Endoscopy
Stryker Endoscopy (San Jose, CA) received FDA approval for the updated Stryker 1788 4K Camera System with Advanced Imaging Modality on September 20, 2023. The 1788 Platform is the latest in the long line of Stryker endoscopic camera systems. It is the first update since the release of the 1688 AIM 4K in 2019 and […]