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 […]
VISTASEAL
Ethicon, Inc. received FDA approval for the VISTASEAL Dual Applicator on April 10, 2019. VISTASEAL is a single-use coagulant device that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate intraoperative bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in […]
SpyGlass Discover
Boston Scientific received FDA approval for SpyGlass Discover in May 2020 SpyGlass Discover is a digital catheter that provides a minimally invasive surgical access to the pancreatico-biliary system through a trans-cystic or trans-ductal approach. SpyGlass Discover is intended to provide direct visualization and allows for accessory devices into the pancreatic-billiary system for both diagnostic and […]
Ambu® aScope Duodeno
Authors: Jorge Humberto Rodríguez-Quintero, MD and David M Pechman, MD Ambu® received FDA approval for aScopeTM Duodeno on July 17th, 2020. The Ambu® aScopeTM Duodeno is a single-use duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP) procedures. It was approved by the FDA along with its reusable processor video unit, the Ambu® aBoxTM Duodeno. The device was […]
Xenoscope
Authors: Sarah Assali, DO, Nova Szoka, MD Xenocor secured FDA approval for the Xenoscope device in January 2020. The Xenoscope is a 5mm disposable articulating laparoscopic device intended to be discarded after a single use, thus minimizing costs associated with re-processing and decontamination, decreasing operating room turnover time, and preventing cross-contamination between different patients and […]
ScopeSeal® Duodenoscope Protective Device
Authors: Danny A. Sherwinter, MD and Pascal Bortz, MD GI Scientific received FDA approval for the ScopeSeal® Duodenoscope Protective Device on October 24, 2019. The ScopeSeal® is a duodenoscope protective device. It is a sterile, single-use disposable device that attaches to the distal end of a duodenoscope to act as a protective barrier to significantly […]
Misonix neXus® Ultrasonic Surgical Aspirator System
Author: Matthew Burstein, MD, PhD Misonix, Inc received FDA 510(k) approval (K190160) for the neXus Ultrasonic Surgical Aspirator System on May 30, 2019. The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is intended for the ultrasonic fragmentation, emulsification and aspiration of both soft and hard tissue. Tissues with weak intracellular bonds like parenchyma, with moderate […]