and MAS Announce First Installation of Combined Data Management
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Rapidpoint Coag Analyzer Joins the RALS-Plus Menu
Automation Systems, Inc. (MAS; Charlottesville, VA) announces
the integration of the Rapidpoint® Coag device
module from Bayer Diagnostics for the RALS®-Plus
Information Management System for point-of-care testing.
The Rapidpoint Coag analyzer is a multi-test analyzer used in
monitoring anticoagulation therapy and determining a patient's
coagulation status at the point-of-care.
RapidPoint Coag technology was developed by Pharmanetics
(Morrisville, NC) and is distributed by Bayer.
The Rapidpoint Coag device module for RALS-Plus
successfully completed beta testing last Summer and is available
in the current commercial release of RALS-Plus.
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Announces Strategic Connectivity Alliances
Inc., the market leader in bedside blood glucose monitoring
systems for hospitals and other medical institutions, announced
today that it has formed two unprecedented strategic alliances
to help impact the financial health of institutions by further
enhancing efficiencies and cost savings in point of care testing
(POCT) and expanding these benefits beyond blood glucose
monitoring into other areas.
LifeScan is the supplier of DataLink™, a labor saving
blood glucose data management system that can interface
completely with the laboratory information system and has
demonstrated positive financial impact for institutions.
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Corporation and Bayer Diagnostics Announce Co-Marketing
Agreement to Increase Diagnosis of Cardiovascular Disease and
Corporation, Diagnostics Division and Cholestech Corporation
announced today the launch of a joint national program aimed at
increasing the "in-office" diagnosis and management of
diabetes and cardiovascular disease. The "Risk Management
Program" is designed to offer more than 100,000 physician
office laboratories and acute care facilities access to the
Bayer DCA 2000 + Analyzer for diabetes management and the
Cholestech L-D-X System for lipid management, through both
Chemicals Ltd offers a high negative predictive value rules out
diabetic nephropathy. The
ImmunoDip combines the simplicity of a dipstick with the
accuracy and reliability of monoclonal antibody technology.
The American Diabetes Association recommends that this
test be done annually in all high-risk patients with positive
results confirmed by more specific methods
Technidyne has added the ProTime3 POC device to its ProTime
Microcoagulation System. This
device monitors the Prothrombin Time (PT) of patient’s blood.
This is critical for patients who are on Coumadin
therapy. This test
may be performed in the physician’s office, a clinic, or at
the home by the patient or caregiver.
Management, Inc offers adhesive ‘medical forms on a label’
come in several sizes and may be used to easily manually record
results on a patient’s chart.
Automation Systems Announces Vendor-Neutral Point-of-Care
Data Management Position
Automation Systems (MAS; Charlottesville, VA) has announced that
they positioned themselves with all of their business
partnerships and strategic alliances so that all point-of-care
devices can be integrated into the company’s state-of-the-art
RALS®-Plus data management system.
goal from the inception of our business in 1994 was to provide
data management solutions for all point-of-care testing,” said
Gregory A. Menke, MAS President and CEO.
“We started the business supporting just critical care
applications , then we added the glucose
RALS-G and now we
have come full circle back to a total vendor neutral position
for all point of care applications with RALS-Plus.”
the Spring of 2001, MAS plans to launch the first version of
RALS-Plus, a modular designed, vendor-neutral information
management system. The
devices included in the initial launch will be all of the Roche
Diagnostics glucose devices including the new AccuChek Inform,
the Roche CoaguChek Pro DM for coagulation, the Roche Chemstrip
101 and the AVL Opti for blood gas.
Additional devices, such as Biosite’s Triage System for
cardiac and congestive heart failure markers, ITC’s Hemachron
coagulation devices, Bayer’s Clinitek 50 urinalysis device,
and a full range of manual tests will be introduced in versions
of the RALS-Plus software scheduled for release throughout the
first year. Ultimately,
RALS-Plus will interface to all manufacturer’s point-of-care
devices and applications, including glucose.
will continue to support the relationship they have developed
with Roche Diagnostics over the past three years.
“We have nearly 250 RALS-G glucose data management
customers connected to Roche devices throughout the U.S. and
Canada and we will continue to support those customers and the
Roche sales and marketing efforts,” Menke says.
“We greatly value the relationship we have developed
with Roche over the past several years and have no desire to
Automation Systems (www.medicalautomation.com) is a privately
held company formed in 1994 by licensing RALS®, a
Remote Automated Laboratory Systems technology from the
University of Virginia. The company is based in Charlottesville,
Virginia and currently employs 115 people.
and Quest terminate exclusive contract and explore point of care
Inc. of Culver City, California and Quest
Diagnostics of Teterboro, New Jersey has terminated the
exclusive distribution and supply contract they both inherited
when Quest acquired SmithKline
Beecham Clinical Labs in 1999.
an offshoot of SmithKline informed Quest it was nearing
attainment of all developmental milestones for contract
activation, but Quest was not ready for contract activation.
Hence, Quest exercised its right to cancel the contract.
Careside is assisting Quest in its evaluation of the POC market
and Careside’s POC technology.
Meter Calibration – Instrument added to assay
help in meeting CAP requirement for calibration verification, Streck
Laboratories has added an analyzer to the Sugar-Chex Control
FastTake is now included on the assay with the LifeScan One
Touch II and SureStep Pro; Bayer Glucometer
Elite, Glucometer III, Glucometer Encore and Encore QA Plus; Medisense
Precision G, Precision QID and Precision PCx; Roche
Accu-Chek, AccuChek Advantage and Accutrend.
Sugar-Chex Control is available at three levels to test the
daily quality control of glucose meters and to provide a quick
method to verify calibration. The control has a 15-month closed
vial stability and a 30-day open vial stability when stored at
room temperature. It performs like whole blood, eliminating the
matrix affect often seen in aqueous products.
Device for Measuring Bilirubin in Infants
(SpectRx, Norcross, GA) for measuring
bilirubin in newborns. The
device is held against the infant’s forehead and completes the
test in 15 minutes. The
measurement is conducted through the skin; no blood is drawn.
Whole Blood Analyzer
Milpitas, CA), a whole blood analyzer designed for patient use
that measures prothrombin time (PT) and calculates the
international normalized (INR).
Device from Hemoscan
Philadelphia, PA) a portable device for measuring hemoglobin,
hematocrit and white blood cell count, through a
thermometer-like probe placed under the patient’s tongue.
System Cleared for Marketing
FastPack System, a point-of-care blood testing system
from Qualigen, Inc. (Carlsbad, CA)
has received marketing clearance from FDA.
The automated analyzer performs quantitative immunoassay
tests for total PSA and provides results in less than 15
Gives Nod to Diabetes Control System
Diego, CA) has received FDA clearance to market its In Charge
Diabetes Control System, a home test that measures both glycated
protein and blood glucose using a small, hand held meter.
Pylori Test Receives CLIA-Waived Status
Biotech’s (Dublin, Ireland) Uni-Gold H. pylori test
has received waived status from the CDRH, which allows sites
with certificates of waiver to perform the test at point-of-care
using whole blood samples. The company’s Uni-Gold H. pylori test screens for the
presence of IgG antibodies to the bacterium Helicobacter pylori.
Cholesterol Monitor Given 510(k)
Technologies (Fort Collins, Colorado) has received 510(k)
clearance from FDA to market the Cholestron Pro, a
hand-held instrument that screens and monitors blood cholesterol
levels from one drop of blood in about three minutes.
Information Systems has signed an agreement with Data Critical
Corp. under which Data Critical will market Sunquest’s
Clinical Event Manager, a wireless, Web-enabled clinical
alerting system that automatically sends clinical data to
clinicians via pager or e-mail.
Introduces SureStepFlexx Glucose System
Inc. has introduced the SureStepFlexx blood glucose
monitoring system with DataLink connectivity options that are
also compatible with LifeScan’s original One Touch II Data
Dock hospital system.
has introduced an Internet-based clinical laboratory
has introduced an Internet-based clinical laboratory
connectivity product for integrated delivery networks in
hospitals and regional commercial laboratories.
The product allows physicians to order laboratory tests
and access results from any computer with a Web Browser.
Advanced functions include verification for medical
necessity and checks for coding discrepancies.