Neuromonitoring device company Raumedic has gained FDA 510(k) clearance to market Neurovent®-PTO. The company says this is the only marketed device that combines measurement of intracranial pressure , intracranial temperature and oxygen partial pressure in one Catheter.
Monitoring
Echo Therapeutics Parts with CEO
Needle-free, wireless continuous glucose monitoring device company Echo Therapeutics has parted company with its CEO, Dr Patrick Mooney, for reasons not thus far disclosed. Board member Robert Doman is stepping into the breach for the time being.
FDA Clears Alere™ MobileLink Home Monitoring System
Alere™ Connect has been granted FDA 510(k) market clearance for the Alere™ MobileLink. The new product offering is one of Alere’s connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Ambio Finds Remote Diabetes Health Monitoring Sweet Spot With FDA Nod
Monitoring specialist Ambio Health, has announced that its wireless remote health and activity monitoring tool, has received Class II FDA 510(k) Clearance.
New CardioChek® Plus Analyzer Delivers Rapid, Simultaneous Lipids and Glucose Results
Polymer Technology Systems, Inc. has introduced the CardioChek Plus analyzer at the annual American Association for Clinical Chemistry (AACC) in Houston. The device is a combination reflectance lipid and electrochemical glucose analyzer that delivers rapid test results for lipids and glucose simultaneously.
FDA Clears Abbott’s FreeStyle Precision Pro Blood Glucose and β–Ketone Monitoring System™
Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, which it describes as an advanced blood glucose monitoring system designed to address the key needs of hospital customers.
Super-Accurate Prostate Monitor Reduces Uncertainty of Radiation Treatment
Swedish company Elekta AB has received CE marking for its Clarity® 4D Monitoring system permitting European clinics to implement this new way of reducing the uncertainty caused by prostate motion during radiation treatment. The device enables physicians to monitor the motion of the prostate with sub millimeter accuracy during the delivery of therapeutic radiation beams.
FDA Clearance of Disposable MR-Conditional Cup Electrodes A “First”
The U.S. FDA has cleared for marketing Rhythmlink’s Disposable MR Conditional Cup Electrodes, the first of a kind to be formally authorized for use.
CE Mark Clinical Trial Of Echo Therapeutics Symphony® CGM System
Needle-free glucose monitoring device company Echo Therapeutics, Inc. has announced that it is initiating a multi-center clinical trial of its Symphony CGM System to support a CE Mark submission. The Company expects to enroll patients over the coming weeks and announce the results of the study in the third quarter of 2013.
Masimo Renews $1Million Pulse Oximeter Bet To “Separate Fact From Fiction”
Masimo, the inventor of measure-through motion and low perfusion pulse oximetry today renewed its $1,000,000 guarantee that Masimo SET® Pulse Oximetry and rainbow® Pulse CO-Oximetry™ will outperform all Nellcor™ pulse oximeters, including the three that Covidien recently announced have received FDA 510(k) clearance with motion claims.
FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters
The FDA has issued a Class I recall, it’s highest category, for Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters. … continue reading “FDA Class 1 Recall For Abbott Diabetes Care’s FreeStyle InsuLinx Blood Glucose Meters”
FDA Clears Covidien’s Nellcor™ Pulse Oximetry Motion Claims
Covidien’s Nellcor™ pulse oximetry systems have received U.S. FDA 510(k) clearance for so-called “motion” claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio.