Department of Veterans Affairs has granted approval to Breathe Technologies' Non-Invasive Open Ventilation (NIOV) system, designed to treat chronic obstructive pulmonary disease. FDA-cleared NIOV system, which will be added to the ...
Tags: Breathe NIOV System, chronic obstructive pulmonary disease
Tandem Diabetes Care, a provider of diabetes management devices, has announced the availability of its t:slim Insulin Pump to customers. The t:slim Insulin Pump features an FDA-approved touch screen which provides a new approach to ...
Tags: T:Slim Insulin Pump, medical application, medical technology
Abbott has obtained the US Food and Drug Administration (FDA) approval for its Omnilink Elite Vascular Balloon-Expandable Stent system, designed as a treatment for atherosclerotic iliac artery lesions with reference vessel diameters of ≥ ...
Tags: Abbott, FDA, approval, Omnilink Elite stent, study, Omnilink Elite
The US Food and Drug Administration (FDA) has granted 510(k) approval to Cardiosolutions' Dexterity Steerable Introducer. The Dexterity Steerable Introducer is designed to simplify the cardiac trans-septal procedure and facilitates ...
Cohera Medical has gained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence the first no-drain clinical trial of its internal surgical adhesive. Designed for use during abdominoplasty ...
Tags: Cohera Medical, Cohera, Surgical Adhesive, surgeries
The US Food and Drug Administration (FDA) has cleared Codman & Shurtleff's pre market approval (PMA) application of Medstream Programmable Infusion system, designed as a treatment for spasticity caused by stroke, cerebral palsy, multiple ...
Tags: FDA, Medstream Programmable Infusion system, Medstream system
Novation has submitted comments to the US Food and Drug Administration (FDA) in support of Unique Device Identification (UDI) system for medical devices. The company believes that the proposed UDI rule, designed to overcome the ...
Tags: Novation, comment, FDA, UDI system, medical devices
Telcare has introduced a diabetes educator program to train diabetic patients how to use the company's wireless-enabled Blood Glucose Monitoring (BGM) system. The objective of diabetes educator program is to recruit and train a group of ...
Tags: Telcare, diabetes educator program
American Medical Systems (AMS), an Endo Health Solutions company, and Allergan have entered into an agreement to jointly develop and seek regulatory approval for the delivery of Botox (onabotulinumtoxinA) using the JetTouch system. ...
Tags: AMS, JetTouch system, medical application
The US Food and Drug Administration (FDA) has cleared the expanded use indication of Boston Scientific's CRE Wireguided Balloon Dilator. The new indication facilitates physicians to perform dilation assisted stone extraction (DASE) of ...
The US Food and Drug Administration (FDA) has granted approval to Actuated Medical's TubeClear system that clears patient feeding and decompression tubes. The CE-marked TubeClear system, which comprises of reusable control boxes and ...
Tags: FDA, TubeClear system, medical technology
Cook Medical has received the US Food and Drug Administration (FDA) approval for its new Evolution colonic controlled-release stent. The new stent design features Kink-resistant flexor technology-based delivery system for pushability ...
Tags: Cook Medical, FDA, medical technology
Endeavour Capital has acquired Access Scientific, a provider of over-wire vascular access technology, for an undisclosed sum. Access' commercial product includes an extended dwell peripheral IV catheter, POWERWAND, which is inserted ...
Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application
The US Food and Drug Administration (FDA) has cleared Aimago's new tablet-based diagnostic imaging tool to identify poorly perfused tissue. The non-invasive EasyLDI perfusion assessment device uses the laser doppler imaging (LDI) ...