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 […]
ECHELON ENDOPATH Staple Line Reinforcement
Ethicon Endo-Surgery, LLC received FDA approval for the Echelon Endopath Staple Line Reinforcement on 10/14/2019. The Echelon Endopath Staple Line Reinforcement is an absorbable, synthetic buttress material intended to be used with the Echelon family of 60 mm endoscopic linear staplers for the purpose of reinforcing surgical staple lines. The individually packaged device consists of […]
INVOCELL® Intravaginal Culture System
Authors: Elizabeth Duarte, MD, Nova Szoka, MD INVO Bioscience received FDA approval to market INVOCELL® Intravaginal Culture System on November 2, 2015. INVOCELL® Intravaginal Culture System is a two-piece, single use device system. Using this system can reduce costs associated with lab fees for In Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection Fertilization (ICSI) by […]
Cardinal Health™ received clearance to market the SMARTGOWN™ and SMARTGOWN™ AIR on July 29, 2020. Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable gowns. These gowns feature AAMI level 4 protection. It is intended to be worn by operating room personnel during surgical procedures. SMARTGOWN™ […]
TransEnterix® Intelligent Surgical Unit (ISU)
Authors: Manuel E. Sanchez-Casalongue, MD, PhD, David M. Pechman, MD TransEnterix® received FDA approval for their Intelligent Surgical Unit (ISU) on March 13, 2020. The Intelligent Surgical Unit is TransEnterix®’s most recent addition to their Senhance® Robotic platform. As a system, Senhance® features independent robotic arms, infra-red eye tracking, and haptic force feedback. The company […]
Battelle Critical Care Decontamination System (CCDS)
Battelle received FDA Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System for N95 respirator sterilization distributed to healthcare workers as of June 6th, 2020. The Battelle Critical Care Decontamination System (CCDS) is a self-contained, mobile decontamination system that uses vapor phase hydrogen peroxide (VPHP) to decontaminate non-cellulose containing N95 masks during anticipated […]