Consumers worried about their risk for osteoporosis soon will have a new resource at their fingertips. By the end of Q2 2013,
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| Crescent Diagnostics' CEO... |
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| The former Idaho Technology Inc. now sports a new name and a new logo. |
The former Idaho Technology Inc., a Salt Lake City−based manufacturer of diagnostics for...
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The INFORM HER2 Dual ISH DNA Probe cocktail assay was approved as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab). |
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| Molecular diagnostics, POC diagnostics, and hematology are expected to see continued growth. |
The current IVD market includes immunochemistry, molecular diagnostics, blood donor...
Congressman Leonard Lance (R-NJ) introduced legislation to promote the development of meaningful treatments for patients with chronic or rare diseases. The “Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN) Cures Act” (HR 3497) would modernize the U.S. drug and diagnostics evaluation and regulatory network by encouraging the...
Late last year, FDA issued its guidance for industry and FDA staff titled “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.” In the guidance document’s introduction, FDA states that it proposes the “...
Last December, PwC released a new report, “Diagnostics 2011: M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects.” This report provides an overview of merger and acquisition deal activity in the IVD industry during the past two years and the factors driving it, an...
Samsung Electronics Company, Ltd., a globally recognizable brand of semiconductor, telecommunication, digital media, and digital convergence technologies based in Seoul, South Korea, has acquired the Nexus division of ITC Nexus Holding Company (ITC), a provider of cardiac point-of-care testing products.
Nexus, based in San Diego and founded not quite three years ago, manufactures and markets the Cardiac STATus, DECISION Point, and VYENT lines of rapid test kits that aid in the...
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...
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 plan to...
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...
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