FDA approves innovative new blood glucose monitoring system
Bayer HealthCare (Tarrytown, NY) has received FDA approval of its CONTOUR Next EZ Blood Glucose Monitoring System. The system includes an easy-to-use meter and test strip sensors with innovative technology.
The CONTOUR Next EZ delivers advanced accuracy that exceeds the requirements of ISO 15197:2003. The proprietary electrochemical mediator and meter algorithm utilized in the system provides a stable, high signal-to-noise ratio that facilitates accurate determination of blood glucose readings, even at low blood glucose levels. It also remains accurate at a wide level of storage conditions, and corrects for common errors. It also is unaffected by hematocrit or common interfering substances in the blood such as vitamin C or acetaminophen.
Molecular test quickly detects C. difficile
The FDA recently approved Quest Diagnostics' (Madison, NJ, and Cypress, CA) Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test will aid in the diagnosis of Clostridium difficile-associated disease.
The test uses real-time polymerase chain reaction performed on liquid or unformed human stool samples. It detects the toxin B gene of C. difficile, including NAP1. It uses a proprietary chemistry that eliminates the need for time-consuming nucleic-acid sample extraction, allowing potentially faster results. The test may be completed in about an hour and is expected to be available immediately.
Endoscopic system for treatment of GERD
The FDA has approved Medigus Ltd's (Omer, Israel) SRS Endoscopic System for minimally invasive endoluminal treatment of gastroesophageal reflux disease (GERD).
The SRS endoscopic device is inserted into the esophagus through the mouth, and does not entail incisions into the abdominal cavity. The endoscope contains a miniature video camera, ultrasonic sights, and a stapling device that enables the operator to perform partial fundoplication.
iPhone-compatible blood glucose monitoring system
Sanofi US's (Bridgewater, NJ) iBGStar Blood Glucose Monitoring System is now available in the United States. The system consists of the iBGStar blood glucose meter and the iBGStar Diabetes Manager App. It is the first FDA-approved blood glucose meter that directly connects to the iPhone and iPod Touch, offering accurate blood glucose monitoring that seamlessly integrates into the busy life of people with diabetes.
The device is sold at Apple Retail Stores and all Walgreens stores nationwide and online at apple.com and Walgreens.com and through Diabetic Care Services.
When the iBGStar is directly connected to an iPhone or iPod Touch and used with the free iBGStar Diabetes Manager App, blood glucose results are presented on the Multi-Touch display quickly after monitoring. iBGStar can also be used independently and results later synched to an iPhone or iPod Touch.
The Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on the go. A share function allows specific data to be sent via email to caregivers and healthcare teams.
Below-the-knee device treats PAD
Angioslide Ltd (Caesarea, Israel) has received FDA approval for its Proteus 3/100 mm, low profile device for reducing embolic burden in below-the-knee vasculature in patients with peripheral artery disease (PAD).
The new device accommodates 0.014-inch guidewires, which significantly broadens the potential use of Proteus technology.
The technology combines the functionality of a balloon angioplasty device with the addition of built-in embolic capture. According to Angioslide, the Proteus device offers practitioners for the first time the ability to capture and remove embolic material with a single device during these challenging below-the-knee interventions.