Welcome!

News Feed Item

FDA Division Director to Discuss Proposed Regulations That Aim to Improve Diabetes Patient Care

WASHINGTON, March 18, 2014 /PRNewswire-USNewswire/ -- On March 19, AACC will host a webinar with FDA division director Courtney Lias, PhD, about FDA's new draft guidance proposing separate performance and accuracy criteria for over-the-counter blood glucose meters used in the home and prescription point-of-care blood glucose meters used in the hospital.

Logo

 

WHO:

Dr. Lias is director of the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics at FDA's Center for Devices and Radiological Health, and is a vocal proponent of improving blood glucose meter accuracy and reliability.



WHEN: 

Wednesday, March 19


2:30–3:30 p.m.



WHERE: 

New Blood Glucose Meter Guidance Unveiled: A Discussion With the FDA



WHY: 

Improved blood glucose (sugar) testing gives healthcare providers and people with diabetes better tools to manage blood glucose levels.

Not all blood glucose meters are created equal. At-home blood glucose meters help many of the 19 million Americans with diabetes to manage their condition, and when people with diabetes are hospitalized, healthcare professionals measure blood glucose using so-called point-of-care meters to determine what medical treatment is needed. Blood glucose monitoring test systems used for patient management in the healthcare setting and for diabetes management in the home setting have different intended use populations with unique characteristics and device design requirements. For example, critically ill patients in healthcare settings may have physiological variables that could interfere with the accuracy of the blood glucose meter.

FDA's new draft guidance aims to improve blood glucose meter safety and efficacy by recommending distinct performance parameters for at-home and point-of-care meters, which are currently evaluated using the same criteria. The agency believes this will ensure that these devices are better designed to meet the needs of their intended populations. If implemented, though, this guidance could also have far-reaching implications for device manufacturers, hospitals, long-term care facilities, and other healthcare providers who perform point-of-care glucose testing and who will have to comply with more stringent personnel and quality control standards. In this webinar, Dr. Lias will answer questions about how this guidance could impact the healthcare professionals directly involved in point-of-care glucose testing and how they can work with FDA to refine the guidance and improve diabetes patient care.

For the full draft guidance, see Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff.

About AACC
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.

Molly Polen
AACC
Director of Communications & PR
(p) 202.420.7612
(c) 703.598.0472
[email protected]

Logo - http://photos.prnewswire.com/prnh/20130701/PH41045LOGO

SOURCE AACC

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
"We have several customers now running private clouds. They're not as large as they should be but it's getting there. The adoption challenge has been pretty simple. Look at the world today of virtualization vs cloud," stated Nara Rajagopalan, CEO of Accelerite, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that China Unicom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, will discuss how VPaaS enables you to move fast, creating scalable video experiences that reach your...
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Is your aging software platform suffering from technical debt while the market changes and demands new solutions at a faster clip? It’s a bold move, but you might consider walking away from your core platform and starting fresh. ReadyTalk did exactly that. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue and over a decade of audio conferencing product development to start an innovati...
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
I’m going to cry tonight, long and hard. I’ll do so as I remember and mourn Jeremy Geelan. I knew Jeremy for almost 20 years, from the time he showed up one day at Cloud Expo’s headquarters in Bergen County, New Jersey, and went to work. The show wasn’t called Cloud Expo then, of course – it was still known as Java Edge, a pioneering event that grabbed developers, architects, and enterprise IT users alike for twice-yearly confabs. Jeremy didn’t have a job there, or even a job offer. He was s...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...