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- Barnev Inc., Developer of FDA-Cleared Computerized Labor Monitoring System Appoints James F. Puffenberger President, Announces Opening of North American Headquarters
- Puffenberger and Barnev team to attend American College of Obstetricians and Gynecologists Meeting May 7 - 9, 2007 (Booth # 222)
- Research articles 2007-05-07
- Aspect Medical Systems Receives FDA Clearance for BIS View™ Monitoring System
- - New monitor expands BIS[R] family of products -
- Research articles 2007-06-27
- LifeChart.com Launches With New Interactive Asthma Monitoring System and First FDA-cleared Electronic Asthma Monitor Available Without a Prescription
- Business Editors & Health/Medical Writers
- Research articles 1999-12-21
- SmartPill Completes Clinical Trial of Its GI Monitoring System; Company Focused Now on the FDA 510 Submission and Preparing to Launch the System in Major International Markets
- BUFFALO, N.Y. -- The SmartPill Corporation (www.smartpillcorp.com), developer of the SmartPill pH.p Capsule, a non-invasive medical device that captures biomedical data from within a patient's GI tract, today announced that the clinical trial of its SmartPill pH.p Capsule and GI Monitoring System, which began in March 2005, were successfully completed.
- Research articles 2005-11-08
Additional Resources
- Transoma Medical Gets FDA Marketing Clearance for Sleuth Implantable ECG Monitoring System
- Wireless News 10-07-2007 Transoma Medical Gets FDA Marketing Clearance for Sleuth Implantable ECG Monitoring System WIRELESS NEWS-October 6, 2007-Transoma Medical Gets FDA Marketing Clearance for Sleuth Implantable ECG Monitoring System C2007 10Meters - http://www.10meters.com Transoma Medical...
- Research articles 2007-10-07
- DexCom Receives FDA Approval for STS™ Continuous Glucose Monitoring System; Novel Technology Designed to Help People with Diabetes Manage Blood Sugar Levels
- SAN DIEGO -- DexCom, Inc. (NASDAQ:DXCM) today announced that it has received Food and Drug Administration FDA approval for its STSTM Continuous Glucose Monitoring System, a first generation device designed to help people with diabetes more conveniently and effectively manage their blood sugar levels. Widely recognized as one of the...
- Research articles 2006-03-27
- BIOTRONIK Receives Approval for the Tachyarrhythmia Monitoring System, TMS 1000
- LAKE OSWEGO, Ore.--BUSINESS WIRE--Nov. 11, 1998--Biotronik Inc. announced today the approval by the U.S. Food and Drug Administration FDA of the TMS 1000 Tachyarrhythmia Monitoring System programmer. The TMS 1000 is the market's first comprehensive patient management system for the implantation, testing and follow-up of...
- Research articles 1998-11-11
- Medtronic Announces FDA Approval of Real-Time Continuous Glucose Monitoring System
- MINNEAPOLIS -- Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration approval of the GuardianR RT Continuous Glucose Monitoring System for improved diabetes management. The system displays real-time glucose values every five minutes and alerts patients when glucose levels become too high or too low. Prior to broad...
- Research articles 2005-08-10
- Draeger Medical files 510 Pre-market Notification for New Patient-worn Monitoring System; Built on industry-standard WiFi technology
- TELFORD, Pa. -- Draeger Medical today announced that it has submitted a 510k pre-market notification to the U.S. Food and Drug Administration FDA for its patient-worn monitoring system known as InfinityR TeleSmart. The Infinity TeleSmart system is a lightweight transceiver that is intended to monitor ECG and SpO2 in both...
- Research articles 2006-05-22
- Transoma Medical Receives FDA Marketing Clearance for Sleuth™ Implantable ECG Monitoring System
- Wireless Remote ECG Monitoring System Enables Physicians to Diagnose Unexplained Fainting in Patients at Home and Work
- Research articles 2007-10-03
- Technical Chemicals & Products Non-Invasive Glucose Monitoring System Establishes Efficacy and Substantial Correlation in First External Studies
- POMPANO BEACH, Fla.--BW HealthWire--Oct. 5, 1998--Technical Chemicals & Products, Inc. (Nasdaq: TCPI), a developer, manufacturer and marketer of point-of-care medical diagnostic products, today announced results of its first external studies establishing efficacy and substantial correlation of its non-invasive TD GlucoseTM Monitoring System compared to finger-stick blood glucose tests already cleared...
- Research articles 1998-10-05
- BIOTRONIK Announces FDA Approval of Its Home Monitoring Technology
- Business Editors, Health/Medical Writers LAKE OSWEGO, Ore.--BUSINESS WIRE--Oct. 11, 2001 BIOTRONIK, Inc. today announced that the U.S. Food and Drug Administration FDA has approved the commercial release of Home Monitoring, the world's first state-of-the-art, wireless communication system for remote monitoring of implantable pacemakers. With the new Home...
- Research articles 2001-10-11
- BIOTRONIK Announces FDA Approval of the Philos DR-T Pacemaker with Home Monitoring Technology
- Business Editors, Health/Medical Writers LAKE OSWEGO, Ore.--BW HealthWire--April 9, 2002 BIOTRONIK, Inc. today announced that the U.S. Food and Drug Administration FDA has approved the commercial release of Philos DR-T Pacemaker with Home Monitoring Technology. This approval continues BIOTRONIK's commitment in providing a state-of-the-art, wireless communication system...
- Research articles 2002-04-09
- Medtronic Receives FDA Approval for Guardian® REAL-Time Continuous Glucose Monitoring System; System Provides Patients Superior Protection than Fingersticks Alone
- MINNEAPOLIS -- Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration FDA has approved the GuardianR REAL-Time System, a doctor-prescribed continuous glucose monitoring CGM system for improved diabetes management. Especially well suited for diabetes patients who frequently monitor their glucose levels, the Guardian REAL-Time System is intended...
- Research articles 2006-07-17
- FDA Seeks UDI Comments
- The U.S. Food and Drug Administration FDA announced on August 9 that it is seeking information on how the use of a unique identifier system could improve the delivery and monitoring of medical cure. The complete notice appeared in the August 11 Federal The U.S. Food and Drug Administration FDA...
- Research articles 2006-10-01
- St. Jude Medical Announces FDA Approval of New Housecall Plus™ System Software Designed to Advance Remote Patient Monitoring
- ST. PAUL, Minn. -- In an effort to provide important new communications benefits to medical professionals who remotely monitor implantable cardioverter defibrillator ICD patients, St. Jude Medical, Inc. (NYSE:STJ) announced today it has received U.S. Food and Drug Administration FDA approval of its version 2.1 software upgrade for the Housecall...
- Research articles 2005-07-07
- DexCom Successfully Completes FDA PMA Inspections; Quality System Regulation and BIMO Inspections Successfully Completed
- SAN DIEGO -- DexCom Inc. (NASDAQ:DXCM) today announced the successful completion of two key inspections related to the FDA review of the PMA application for its Short-Term Continuous Glucose Monitoring System (STSTM). DexCom filed its PMA for the STSTM system in March and was notified in May that the FDA...
- Research articles 2005-08-02
- Transoma Medical Receives FDA Marketing Clearance for Exclusive Capability Providing Immediate Access to Critical ECGs on Mobile Handheld Device
- Full commercial launch of Sleuth ATâ?¢ Implantable Cardiac Monitoring System underway with clearance of instant Data Review capability ...
- Research articles 2009-06-01
- FDA Gives 510K Approval to integriti, a New Portable Patient Monitoring System from Alliance Instruments
- VANCOUVER, Wash.--BUSINESS WIRE--March 23, 1999--Alliance Instruments, a maker of point-of-care devices, announced today that its integriti system has received 510K approval from the U.S. Food and Drug Administration FDA.
- Research articles 1999-03-23
- FDA Clears New GlucosePilot(TM) Blood Glucose Meter System
- Aventir Biotech announced today that it has received 510k clearance for its GlucosePilotTM Blood Glucose Monitoring System. The GlucosePilotTM offers an easy-to-use, cost effective and convenient way for patients and hospitals to manage diabetes. Research has shown consistent glucose monitoring; helps improve the control of glucose levels in patients...
- Research articles 2007-07-31
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