ActivSight Intraoperative Imaging System
Authors: Matthew D. Burstein, MD, PhD & Chibueze A. Nwaiwu, MD Activ Surgical, Inc. received FDA approval for the ActivSight Intraoperative Imaging Module on April 8, 2021 (K203550). The ActivSight Intraoperative Imaging Module installs between a standard laparoscope and white light camera system, with a separate proprietary “Light Engine” custom light source that combines white […]
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
Authors: Samir Narula, MD & Luca Milone, MD The da Vinci X/Xi (IS4200/IS4000) and da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments, produced by Intuitive Inc, have a unique articulating design at their distal tips that mimics the human wrist. While seated at the console of the surgical system, the surgeon can precisely control movements of the […]
Hominis
Memic Innovative Surgery Ltd., Inc. received FDA approval for the Hominis® Surgical System on February 26th, 2021. The Hominis Surgical System is an endoscopic instrument control system intended to control the Hominis robotic arms for use during single site, natural orifice laparoscopic assisted benign transvaginal surgery. Intended uses include: salpingectomy, oophorectomy, adnexectomy, ovarian cyst removal, and […]
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Authors: Yasir A. Al-Dojaily BMSc (Medical Student)., Nawar A. Alkhamesi MD, PhD, FRCS (Gen. Surg.), FRCS, FRCSEd., FRCSC, FACS, FASCRS Aescolap Inc. received FDA approval for PAS-Port Proximal Anastomosis System on September 2nd, 2020. Cardica Inc. (Redwood City, California) originally received FDA approval for the PAS-Port proximal anastomosis system on September 5th, 2008 before its […]
CoolSeal™
Bolder Surgical received FDA approval for CoolSeal™ on October 6, 2020. The CoolSeal™ Trinity is a 5mm bipolar surgical instrument intended to be utilized for the ligation and division of vessels, soft tissue, and lymphatics during minimally invasive and open procedures. It is a single-use device that has an associated compatible generator which provides radiofrequency […]
Author: Dominic Papandria, MD Alesi Surgical received FDA approval for the Ultravision™ Visual Field Clearing System on 4 May 2020. Predicate systems by the same vendor were approved in Sept 2018 and in May 2015. The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created […]
Authors: Nicolas Fuentes, M.D., David Pechman, M.D. EndoGI Medical, Ltd. received FDA approval for EndoGI Biliary Stent System on May 27th, 2020. The EndoGI Biliary Stent System is a single-use endoscopic preloaded device that allows for the deployment of radiopaque polymer stents into the biliary system for drainage of the biliary system, splinting of the […]
Ventway Sparrow
Authors: Maren Healey, Nova Szoka MD, FACS, FASMBS Inovytec Medical Solutions Ltd. received FDA approval for the Ventway Sparrow ventilator on January 29, 2021. The Ventway Sparrow is a compact, portable ventilator weighing 2.2 pounds that can be used in the hospital, pre-hospital, and field environments for invasive and non-invasive ventilation. Specifically, the ventilator is […]
NaviCam™ Stomach Capsule System
Authors: Ashton Cross, Nova Szoka, MD, FACS, FASMBS AnX Robotica, Inc. received FDA approval for the NaviCam™ Stomach Capsule System on May 22, 2020. The NaviCam™ Stomach Capsule System is a magnetically maneuvered capsule endoscopy system consisting of a single-use ingestible capsule and a magnet linked to a physician operated console. The capsule contains a camera […]
Intuitive Ion Endoluminal System
Intuitive Ion endoluminal system – A robotic-assisted endoluminal platform for minimally invasive peripheral lung biopsy The Intuitive Ion endoluminal system received clearance from the Food and Drug Administration (FDA) in February 2019. The Ion endoluminal system is a robotic-assisted platform for minimally invasive biopsies of peripheral lung lesions, manufactured by Intuitive Surgical Inc. This American […]