Navigation Links
Magellan Diagnostics Receives FDA Clearance for LeadCare Ultra Bench-top Clinical Lead Analyzer
Date:8/26/2013

BILLERICA, Mass., Aug. 26, 2013 /PRNewswire/ -- Magellan Diagnostics, Inc., the leader in clinical lead testing systems for both point-of-care and laboratory analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Ultra Blood Lead Testing System in the US for the quantification of lead levels in blood. 

LeadCare Ultra is the first "plug-and-play" solution for laboratory lead analysis.  It brings a significant improvement in the speed and cost of lead testing while providing labs the first bench-top lead testing system with an easy-to-use and flexible design.  

"Our lab was impressed by how easy LeadCare Ultra was to set up and run," said Lindsay Gauthier, Chemistry Manager at Cambridge Hospital in Cambridge, Massachusetts, who participated in the system's clinical trial.  "Compared to other systems, which can require significant maintenance and monitoring, Ultra really simplified our workflow."

According to the Centers for Disease Control and Prevention (CDC), there are over half a million US children affected with elevated blood lead levels, which can impair cognition, reduce IQ, and cause attention-deficit disorders.  Because the symptoms of lead exposure are non-specific and often sub-clinical, a blood test is the only way to identify an exposed child.

Amy Winslow, president of Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Ultra System. Since there are still many children and adults at risk of lead exposure who don't get tested, we feel it is important to offer solutions that can help expand access to lead testing.  LeadCare Ultra does this by offering a simple, cost effective solution for laboratories of all sizes." 

The LeadCare Ultra System is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades and that is currently helping over 5,000 clinicians rapidly test and identify individuals who suffer from lead exposure.   For more information on the LeadCare Ultra System, visit www.lcultra.com.

About Magellan Diagnostics
Magellan Diagnostics is a medical device company that provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services focused on lead testing. Headquartered outside Boston in Billerica, Massachusetts, Magellan is dedicated to offering high-quality, reliable products that help identify children and adults at risk of harm due to lead exposure.  We are committed to educating clinicians, policy makers, payers, families and communities about the permanent health damage caused by lead and how to detect and address lead exposure.  For more information, visit www.magellandx.com.


'/>"/>
SOURCE Magellan Diagnostics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. QBC Diagnostics Awarded GSA Contract
2. Quest Diagnostics Establishes Unique Healthcare Identifier to Improve Access to Vital Patient Health Information; 80 Million Patient IDs Created to Date
3. Heightened Awareness, Coupled with Expanding Patient Pool, Stimulates Sleep Apnea Diagnostics and Sleep Services Market, Says Frost & Sullivan
4. Ariosa Diagnostics to Present and Exhibit at the 16th International Conference on Prenatal Diagnosis and Therapy
5. ZINO Society Targets Medical Devices, Healthcare IT and Diagnostics
6. Quest Diagnostics To Speak At The Wells Fargo Securities 2012 Healthcare Conference
7. Breakthrough Prostate Cancer Diagnostics
8. NicOx Signs Worldwide Licensing Agreement With Rapid Pathogen Screening, Inc. For Ophthalmic Diagnostics
9. Frost & Sullivan: Expanding Sample Prep Market Supports Growth Trends in Molecular Diagnostics Markets
10. QIAGEN Unveils Initiative to Create Next-Generation Sequencing Portfolio for use in Clinical Research and Molecular Diagnostics
11. Quest Diagnostics to Release Second Quarter 2012 Financial Results on July 19
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... , Feb. 10, 2016  Resolve Therapeutics, ... transformative new approaches to the treatment of lupus ... of a multiple ascending dose study in patients ... compound RSLV-132. --> ... placebo-controlled multiple ascending dose study of RSLV-132 in ...
(Date:2/10/2016)...  Rich Pharmaceuticals, Inc. (OTC Markets: RCHA) ("Rich Pharmaceuticals" ... of its issued and outstanding shares of common stock ... 11, 2016. The Company,s common stock will trade on ... temporary ticker symbol "RCHAD". After 20 trading days, the ... (RCHA).  --> --> ...
(Date:2/10/2016)... , Feb. 10, 2016  The Baylor ... received an in-kind gift from ... VeinViewer® Vision vein finder for the nursing ... students as they learn how to start ... with traditional technique. ...
Breaking Medicine Technology:
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... practitioner, is known locally for a series of therapeutic sessions to help Los ... their characters and in their lives. The series, known as “Mindfulness for Actors ...
(Date:2/10/2016)... ... February 10, 2016 , ... MetLoop ... revolutionary new 2.0 version at the International Roofing Expo in Orlando, Florida on ... the world's most advanced weather technology in the hands of consumers, roofing contractors, ...
(Date:2/10/2016)... ... February 10, 2016 , ... The Wickman Agency in Garland, ... the local community. Pledging to select a new beneficiary every 60 days, the ... Their goal is to bring community awareness to important local causes by forming ...
(Date:2/10/2016)... ... 2016 , ... Ongoing news of the ravages of traumatic brain injury (TBI) ... survey that takes a closer look at cases of TBI being managed by their ... TBI among the aging population, and identifies the challenges associated with their care. , ...
(Date:2/10/2016)... ... 10, 2016 , ... Armune BioScience signed a definitive agreement with ... service centers across the country. Launched in April of 2015, Apifiny is the only ... cancer. Apifiny order volume exceeded 3,000 tests in 2015. Primary care physicians and urologists ...
Breaking Medicine News(10 mins):