Ortho Clinical Diagnostics (OCD), in partnership with the National Association of Chronic Disease Directors (NACDD), published consumer-survey results and a report revealing the state of blood test health literacy in the United States, with strategies to support patient education and empowerment. The survey and report are part of the Know Your Numbers campaign, which was...
 |
Popular Topics |
|
Ask The Experts |
|
IVDT Insight Blog |
|
Trends & Perspectives |
Last October, the European Diagnostic Manufacturers Association (EDMA; Brussels) hosted the European IVD Forum 2011. The primary purpose of the forum was to facilitate discussions among high-level stakeholders on the challenges faced by healthcare systems. To this end, the forum was attended by members of the IVD industry, key policymakers from European and national...
In September of last year, Sony Corp. acquired venture corporation Micronics Inc. (Redmond, WA) through its wholly owned subsidiary, Sony Corp. of America. Sony bought Micronics to boost its own R&D in the area of point-of-care diagnostic equipment and to accelerate commercialization of these products.
“We don’t have a specific business...
The primary election issue for IVD companies is the evolution of the clearance and approval system. My belief is that the rules and regulations are fine, and OIVD management needs to make improvements to clarify, standardize, and speed up the clearance and approval processes. Compliance issues need to be dealt with outside of the clearance/approval system, and the IVD...
Back in late July of this year, the Institute of Medicine (IOM) recommended that FDA replace the 510(k) medical-device clearance process with something brand new. (Under current regulation, to obtain 510(k) clearance, a manufacturer must demonstrate that the device is substantially equivalent to a device that was in legal...
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovarian cancer. The appeals court ruled that companies can obtain...
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion...
GE announced this fall its plan to invest $1 billion during the next five years on R&D programs aimed at detecting, diagnosing, and treating cancer faster and more effectively. GE’s primary focus is on detection and treatment of breast cancer, with an eye toward cancerous tumors of all kinds.
Ron Andrews, CEO of Clarient, a GE Healthcare company,...
Submissions for the first challenge will close on November 20, 2011. All entries must include a clear, detailed proposal describing an innovative, original breast-cancer detection, diagnosis, or treatment technology or process.
Applicants should fill out the submission form (available online at http://challenge.healthymagination.com/health) and be sure to have the following...
In April Seegene Inc. (Seoul) announced a partnership with Samsung Medical Center (Seoul) to codevelop molecular diagnostics for cancer. Seegene will bring to this collaboration its molecular diagnostic technology knowledge, and Samsung Medical Center will contribute its clinical and disease-pathology expertise. Samsung Medical Center will...
Since the 1960s, South Korea has achieved massive growth and global integration to become a high-tech industrialized economy. Today South Korea boasts a GDP of approximately $1.459 trillion, and currently is among the world’s 20 largest economies.
In 2007, the United States and South Korea signed a comprehensive free-trade agreement (FTA). It is the...
In March, FDA’s Molecular and Clinical Genetics Panel held a meeting to discuss and make recommendations on scientific issues concerning direct-to-consumer (DTC) genetic tests that make medical claims.
FDA opened the meeting with a presentation outlining the history and landscape of DTC clinical genetic tests. FDA ended...
Industry observers and Wall Street traders alike have taken a keen interest in Gen-Probe’s activities and investor announcements this quarter. The interest began in late April, when a news item on Bloomberg’s Web site reported that Gen-Probe had hired financial giant Morgan Stanley to find it a buyer. The Bloomberg story cited “three people with knowledge...
In a move consistent with its busy acquisition history in 2010, Thermo Fisher Scientific (TFS) announced at the end of last year its plans to acquire chromatography-system manufacturer Dionex Corp. (Sunnyvale, CA). TFS has also recently completed its sale of Athena Diagnostics and Lancaster Laboratories, two laboratory-testing-services businesses.
Proposed Dionex Purchase. As of April 4 of this year, TFS had extended its cash tender offer to 7:00 p.m. EST on May 13....
Reactions to FDA’s proposed Innovation Pathway, part of its new Medical Device Innovation Initiative, are mixed. The Innovation Pathway, if instituted, will be a “priority program for new, breakthrough medical devices,” according to FDA. It is one component of a broader effort by CDRH to “encourage cutting-edge technologies among medical device manufacturers.” The first product submission for this review program is a robotic prosthetic...
|
Most Recent |
Advertisers | Privacy Policy | Contact | Subscribe | Sitemap
© UBM Canon 1996-2012