Philips EarlyVue VS30
Author: Timothy S. Snow, DO Philips received FDA approval for the EarlyVue VS30 on 10/27/2019. The EarylVue VS30 is a vital sign monitoring device utilized in clinical patient care settings for adults, children, and neonates. The platform uses Philips’ Early Warning System (EWS) to help recognize signs of patient degradation prior to the presence of […]
XACT Robotic System
Author: Kate Lak, MD XACT Robotics received FDA approval for its XACT Robotic System for image guided percutaneous procedures on 10/03/2019. The XACT Robotic system is a patient-mounted system that uses robotic technology and 5 degrees of freedom to deliver continuous targeting feedback for image-guided procedures. The system is compatible with multiple imaging modalities and […]
Stentfix OTSC System Set
Author: Salvatore Docimo, Jr., DO Ovesco received FDA Approval for the Stentfix OTSC System Set in October 2019. The stentfix OTSC (over the scope clips) system is designed for stent fixation in the digestive system. The clip can be deployed either at the proximal or distal end of the stent. The deployment cap has been […]
Advanced Sterilization Products (ASP) STERRAD Sterilizers
Authors: Xavier Pereira, MD, David Pechman, MD Advanced Sterilization Products (ASP) STERRAD sterilizers (STERRAD 100S Cycle, STERRAD NX Standard Cycle, and STERRAD 100NX Express Cycle) received emergency approval for decontamination of N95 respirators on April 11, 2020. The world is currently facing an unprecedented public health crisis caused by the coronavirus disease (COVID-19). The respiratory […]
qSARS-CoV-2 IgG/IgM Rapid Test
Authors: Diane Bronikowski, Nova Szoka, MD Cellex Inc received FDA approval for qSARS-CoV-2 IgG/IgM Rapid Test on April 1, 2020. Designed in response to the COVID-19 pandemic, the qSARS-CoV-2 IgG/IgM Rapid Test is the first FDA approved assay of its kind. The test qualitatively detects IgG and IgM immunoglobulins against SARS-CoV-2 present in venipuncture whole […]
Abbott ID NOW™ COVID-19 Test
Authors: Gustavo Romero-Velez, MD, David M Pechman, MD, MBA Abbott received FDA approval for ID NOW™ COVID-19 test on March 27, 2020. The Abbott ID NOW COVID-19 test runs on the Abbott’s ID NOW™ platform and allows for rapid point of care molecular testing. Currently, there is worldwide health emergency caused by the coronavirus disease (COVID-19). […]
Saranas Early Bird
Authors: Brendan Jones, MD; Nova Szoka, MD, FACS, FASMBS Saranas received FDA de novo approval for Early Bird Bleed Monitoring System on March 5, 2019. This device is a Class II device. The Early Bird Bleed Monitoring System is a first-of-its-kind device on the market to allow for early detection of endovascular bleeding complications. It […]
Lumendi DiLumen Ik™ Endolumenal Interventional Knife
Author: Antonio Caycedo-Marulanda Lumendi received FDA approval for new DiLumen Ik™ endolumenal interventional knife in August of 2019. Lumendi is a Connecticut-based medical device innovator company that designed a single-use disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. It is also designed to deliver a seamless […]
Fidmi Medical Low-Profile Enteral Feeding Device
Author: Rasa Zarnegar Fidmi Medical received FDA approval for Low-profile Enteral Feeding Device on October 16th, 2019. Fidmi Medical has developed a Low-profile Enteral Feeding Device that is a percutaneous gastrostomy tube placed endoscopically similar to the conventional PEG tubes. Conventional feeding tubes tend to get dislodged or clogged requiring replacement frequently. This novel device […]
SynchroSeal and E-100 Electrosurgical Generator
Authors: Sarah Pratt MD, David Pechman MD Intuitive Surgical received FDA approval for the SynchroSeal and E-100 Electrosurgical Generator on November 14, 2019. The SynchroSeal is an advanced bipolar surgical energy device for the da Vinci X® and Xi™ systems. It is an 8mm single-use instrument that has 60° of wristed articulation and a curved […]
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 […]
PenBlade
Author: Nova Szoka, MD PenBlade by PenBlade, Inc. is registered as a Class 1 device with the FDA – registration number 3010780223. PenBlade is a single-use safety scalpel with a retractable steel blade. The device activates like a click pen and retracts via a separate button near the front of the handle, allowing the user […]
Hemospray™
Author: David Pechman, MD Cook Medical received FDA approval for Hemospray on May 7, 2018. HemosprayTM is a proprietary mineral powder that can be administered endoscopically and promotes hemostasis. The powder, inorganic and inert, forms an adhesive layer when it comes into contact with fluid. The adhesive layer provides mechanical compression and promotes hemostasis. In […]
EnVisio™ Navigation System
Authors: Marguerite Ballou, MD; Nova Szoka, MD Elucent Medical received FDA approval for the EnVisio™ Navigation System on March 22, 2019. The EnVisio™ Navigation System is a technology that detects the presence of a SmartClip™ Soft Tissue Marker using an electromagnetic localization system. The SmartClip™ is a permanent marker inserted percutaneously at a biopsy site […]
symphonX™ Surgical Platform
Author: Eugene Cho, MD FortiMedix received FDA approval for the symphonX™ (FMX314) Surgical Platform on August 26, 2016. The symphonX™ surgical platform provides a path of entry for laparoscopic instruments and camera through a single site and allows for triangulation similar to standard laparoscopy. The device fits through a standard 15-mm trocar and has 4 channels, […]
TransEnterix Senhance Ultrasonic System
Authors: Gustavo Romero-Velez, MD; David M Pechman, MD TransEnterix received FDA approval for Senhance Ultrasonic System on January 15, 2019. The Senhance Ultrasonic System is an advanced energy device that couples with Senhance robotic surgery platform. With the Senhance Surgical System, TransEnterix strives to improve minimally invasive surgery by digitizing the interface between the surgeon […]
Artisential Articulating Laparoscopic Instrument(s)
Authors: Brenden Jones, MD; Nova Szoka, MD LIVSMED developed ArtiSential Articulating Laparoscopic Instruments; they were registered as Class I medical devices with the FDA in 2019. The ArtiSential line of articulating laparoscopic instruments is designed to provide the user with fully articulating, wristed motion during laparoscopic surgery. The instruments are constructed with two pinching triggers […]
Da Vinci SP Surgical System, EndoWrist SP Instruments, And Accessories
Author: Thom E. Lobe, MD Intuitive Surgical, Inc., received FDA approval for its Da Vinci SP Surgical System, EndoWrist SP Instruments, and accessories on 03/14/2019. The Da Vinci SP Surgical System represents the company’s 4th generation robot. The da Vinci SP (single port) system includes three, multi-jointed, wristed instruments and the first da Vinci fully […]
JET Multi-Instrument Safety Holster
Authors: Shogik Abramyan, MD; Luca Milone, MD Jet Surgical Devices’ JET Multi-Instrument Safety Holster was registered as a Class 1 device with the FDA on May 19, 2015 – registration number 3011636272. The JET Multi-Instrument Safety Holster is the first dual compartment holster. It is designed for holding multiple electrosurgical instruments and to reduce fires […]
M-Close Kit
Author: Kate Lak, MD New Wave Endosurgery received FDA approval for the M-Close Kit in 2005. The M-Close Kit combines a port closure device with a mechanism for targeted injection of local anesthetic. The device is deployed through a laparoscopic port and a set of needles is used to inject local anesthetic, then penetrate the […]