Author: Iswanto Sucandy, MD, FACS (Hepatobiliary Surgery, AdventHealth Tampa) Tachosil received FDA approval on April 6, 2010 for Baxter & Nycomed as a hemostatic product to be used during cardiovascular and hepatic surgery. TachoSil is a Fibrin Sealant Patch comprised of human fibrinogen and human thrombin coated onto an equine collagen sponge. The collagen sponge […]
IB-Stim
Authors: Benjamin L. Reed, MD, Nova Szoka, MD Innovative Health Solutions received FDA approval to market IB-Stim on June 7th, 2019. IB-Stim (formerly Neuro-Stim) is a percutaneous nerve stimulator intended for use as an adjunct in the treatment of abdominal pain in adolescent patients with irritable bowel syndrome (IBS). The device consists of a small, […]
The Quantra Hemostasis Analyzer platform
Authors: Shogik Abramyan, MD; Luca Milone, MD HemoSonics received FDA notification in March 12, 2019 regarding the Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge being granted de novo marketing. The Quantra Hemostasis Analyzer platform is a viscoelastic point‐of‐care device designed for automated and rapid noncontact assessment of hemostasis. It uses Sonic Estimation of Elasticity via […]
PENTAX Medical DEC™ HD Partially Disposable Duodenoscope
Author: Gustavo Romero-Velez, MD, David M. Pechman, MD, MBA PENTAX Medical received FDA approval for DEC™ HD Partially Disposable Duodenoscope on November 15, 2019. DEC™ is a high definition duodenoscope with some disposable components including a sterile cap and elevator lever. The device was developed as a response to the FDA and CDC’s call for advancement in […]
Author: Matthew Burstein, MD, PhD Suture Ease received FDA approval for the CrossBow Fascial Closure System on 12/01/2017. The CrossBow is a trocar with guide channels for a trans-fascial suture passer. The trocar has deployable snares for recovery of the intraperitoneal suture tails delivered via the suture passer. The system is used for closure of […]