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Recent Developments in the Point-of-Care Marketplace

Volume 1

Copyright 2001

By

Dr. Thomas E. Colonna


Table of Contents
FDA Clears First Diagnostic Blood Test for Congestive Heart Failure
FDA Clears Home Cholesterol Monitor With Smart Card Technology
FDA Clears AvoSure PT System for Consumer Use to Measure Blood Clotting Time
PharmChek Patch Available for Use in Fight Against Drugs of Abuse
FDA Clears New Diagnostic Test For Helicobacter pylori
New Handheld Computers to Track Patient Pain Over Time
FDA Clears New Diagnostic Test to Detect Recurrent Bladder Cancer
FDA Clears New Diabetes Management System
FDA Clears New Test to Detect Amphetamines Including Ecstacy
FDA Clears Noninvasive Screening System for Cardiovascular Disease
FDA Approves GERD Monitoring System
FDA Clears Vasotrax Handheld Blood Pressure Monitor
FDA Grants Clearance to Careside, Inc.’s Hemoglobin and Hematocrit 
Point-of-Care Blood TestsFDA Clears UriSite Urine Collection Kit for Microalbumin/Creatine Testing
Identify Bacteria With the OnSite Urine Culture Device
New Pepsinogen-1 Test Aids in the Detection of Peptic Ulcers and Gastric Caricoma
FDA Clears New Blood Glucose Monitoring System
FDA Grants Clearance to Metrika Inc.’s Digital Response® (DRx®) HbA1c Patient Monitor
FDA Grants Clearance to Qualigen Inc.’s FastPack Point-of-Care Blood Testing System
New Dade Behring Diagnostic Test for Thrombosis
At Home Prostate Disease Test
Bayer Diagnostics Low Range Heparin Management Test
FDA Clears Careside Inc.’s Point of Care Direct Bilirubin Test
FDA Clears Trinity Biotech PLC Uni-Gold H. pylori Immunoassay
FDA Clears Quantech Ltd Human Chorionic Gonadotropin Pregnancy Test
FDA Clears Digene Corp.’s Hybrid Capture II Test for Detecting Neisseria Gonorrhea

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