Canon Medical Systems USA Advanced Intelligent Clear-IQ Engine (AiCE)
Author: Eugene Cho, MD Canon Medical Systems USA received 510(k) FDA clearance for its Advanced Intelligent Clear-IQ Engine on October 21, 2019 and clearance for three computed tomography models and one magnetic resonance imaging model using the technology, Aquilon One on 6/12/2019, Aquilon Precision on 7/5/2019, Aquilon Prime on 2/21/2020 and Vantage Galan 3T MR3020 […]
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 […]