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 […]
Ellume COVID-19 Home Test
Authors: Evan Liggett, MD, Shintaro Chiba, MD Ellume Limited received FDA emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home rapid diagnostic test for COVID-19 on December 15, 2020. The Ellume COVID-19 Home Test is a lateral flow immunoassay that uses liquid obtained from dipping a nasal swab from an individual 2 years […]
Ovesco Endoscopy Gastroduodenal Full-Thickness Resection Device (FTRD®) Set
Authors: Jorge Humberto Rodriguez-Quintero, MD, David M Pechman, MD Ovesco Endoscopy AG (Tubingen, Germany) received FDA approval for the Gastroduodenal Full-Thickness Resection Device (FTRD®) Set on June 2, 2020. The Ovesco FTRD® system is a family of disposable devices that each allow for full-thickness endoscopic resection and tissue diagnosis for different types of gastrointestinal lesions. The FTRD® sets […]
ProCell™ Surgical Sponge – Blood Recovery Unit
ProCell Surgical, Inc. received FDA approval for ProCell™ Surgical Sponge – Blood Recovery Unit on June 1st, 2020. The ProCell™ Surgical Sponge – Blood Recovery Unit (ProCell™) is a device used to extract blood from surgical sponges, automating the manual hand-wringing process. Surgical sponges are placed into the ProCell™ unit, the blood is extracted and collected […]
Micro-Tech Single Use Electrosurgical Knife
Authors: Christina Cuoccio, MD; Luca Milone, MD, FACS Micro-Tech (Nanjing) Co., Ltd. received FDA approval for the Single Use Electrosurgical Knife on July 24th, 2020. Since the device is substantially equivalent to legally marketed devices that were previously marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, […]
Tégo and the Vitls Platform
Authors: Katheryn Hope Wilkinson and Kate Lak, MD Vitls Inc received FDA approval for Tégo and the Vitls Platform in July of 2020. The Vitls Platform is a wireless physiologic monitoring system that collects data from a remote patient sensor. The Tégo VSS sensor, as a component of the Vitls Platform, is a waterproof patch […]