- Location
FDA 510 k clearance
"-
Intravascular Imaging May Just Have Become Easier for Boston Scientific iLAB Customers
Aug 14, 2014Intravascular imaging may just have become easier for Boston Scientific (Marlborough, MA) iLAB customers. The company has launched a more powerful imaging device that could also reduce confusing workflows, shorten procedure times, and ...
-
FDA Raising Cancer Concerns Over How Robotic Hysterectomies Are Performed.
Apr 23, 2014Intuitive Surgical stock fell 11.5% in value on Wednesday after a disappointing quarterly earnings report and the FDA raising cancer concerns over how robotic hysterectomies are performed. The Sunnyvale, CA–based maker of da Vinci ...
-
Varian Medical Systems Has Received FDA 510(K) Clearance for Its Proton Therapy System
Jan 15, 2014Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system. Varian's ProBeam system gives clinicians options for delivering dose precisely in order to minimize dose to healthy ...
Tags: Health, Medicine, Varian Medical Systems
-
FDA 510(K) Clearance for Sirius MRI Marker Has Been Obtained by C4 Imaging
Dec 10, 2013C4 Imaging, a US-based medical device company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Sirius MRI marker. Sirius is a positive-signal MRI marker that will be used following treatment of ...
Tags: C4 Imaging, Sirius MRI
-
FDA 510(K) Clearance to Use Additional Specimen Types Has Been Obtained by Roche
Dec 6, 2013Roche announced has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the use of four additional specimen types with the cobas CT/NG v2.0 test to help physicians diagnose Chlamydia trachomatis (CT) and Neisseria ...
-
FDA 510(K) Clearance for Tomtec-Arena 1.0 Software Is Obtained by Tomtec Imaging
Dec 4, 2013Germany-based TomTec Imaging Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its TomTec-Arena 1.0 software solution. TomTec-Arena 1.0 is the newest addition to the company's product portfolio. ...
-
FDA 510(K) Clearance of New Medical Diagnostic Monitor Is Obtained by Nec Display Solution
Dec 4, 2013NEC Display Solutions of America has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its 24-inch MultiSync MD242C2 widescreen display for diagnostic review applications in healthcare organizations. MultiSync ...
-
FDA 510(K) Clearance for Proton Therapy System Is Obtained by Sumitomo
Dec 2, 2013Sumitomo Heavy Industries has obtained the US Food and Drug Administration (FDA) 510(k) clearance of its Proton Therapy System, a form of radiation therapy, which employs proton beams to kill cancer cells with better dose distribution in ...
Tags: Proton Therapy System, Sumitomo
-
US-Based Bruker Has Obtained 510(K) Clearance From The US Food and Drug Administration
Nov 29, 2013US-based Bruker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MALDI Biotyper CA system to identify Gram negative bacterial colonies cultured from human specimens. Bruker's MALDI Biotyper CA system ...
-
Atricure Announces FDA Approval to Begin Enrollment in a Clinical Study
Nov 25, 2013AtriCure, a developer of solutions to treat atrial fibrillation (Afib), has announced the US Food and Drug Administration’s (FDA) approval to begin enrollment in a clinical study of its AtriClip left atrial appendage exclusion system. ...
Tags: AtriCure, Stroke Prevention
-
Fenwal Receives FDA 510(K) Clearance for The Alyx System Software Version 3.1.
Nov 25, 2013Fenwal, a Fresenius Kabi company, has received the US Food and Drug Administration (FDA) 510(k) clearance for the Alyx system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and ...
-
Dallen Medical Obtaines 510(K) Clearance From FDA for Its Tensyn Band
Nov 25, 2013US-based Dallen Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Tensyn band, designed for the fixation of ankle syndesmosis. Previously, the company has obtained FDA 510(k) clearances for its ...
Tags: Dallen Medical, Tensyn Band
-
A New Technology Based on Fish Skin Can Be Used to Heal Human Skin Wounds.
Nov 22, 2013A new technology based on fish skin can be used to heal human skin wounds. This week, Kerecis Limited announced that it received FDA 510(k) clearance for a fish skin-based tissue regeneration technology. The technology is designed for the ...
Tags: Tissue Regeneration Technique, FDA
-
Mobile Cardiovascular Health Firm AliveCor Has Announced The Debut of Aliveinsights
Nov 22, 2013Mobile cardiovascular health firm AliveCor (San Francisco, CA) has announced the debut of AliveInsights, a new service that enables patients to send ECG data generated by the company's heart monitors to cardiologists or cardiac technicians ...
Tags: ECG, Heart Monitors, Smartphone
-
Civco Medical Obtaines 510(K) Clearance From FDA for Its Ex3 Stepper
Nov 22, 2013CIVCO Medical Solutions, a medical technology company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its EX3 stepper, which is used while performing real time planning for low dose rate (LDR) or high dose ...
Tags: CIVCO Medical, Medicine