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 […]