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 […]