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The first Swine Flu test nod goes to Quest Diagnostics

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First Swine Flu test nod goes to Quest Diagnostics
New Jersey diagnostics maker wins FDA approval for its Focus Diagnostics subsidiary’s H1N1 influenza virus test. Read More more arrow

sponsor - mcclellan-automation.comKinetic Concepts bounces back in patent war against Smith & Nephew
The U.S. Patent Office upholds a trio of KCI patents in the worldwide battle over negative-pressure wound therapy patents between the Texas wound care firm and the British conglomerate. Read More more arrow

Medtronic to pay $442 million to settle Abbott Labs stents patent battle
Minneapolis devices giant inks settlement deal with one of its arch-rivals in vascular stent patent infringement dispute. Read More more arrow

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MassDevice blog: Unhealthy alliance?
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Weekly Wireless Roundup: Physicians Interactive acquires Skyscape
Health marketer Physicians Interactive acquires mobile medical publisher Skyscape; the wireless health industry’s government lobbying efforts; medtech to horn in on the fitness industry’s wireless sensor market; and the appeal of clinician-facing technologies over customer-facing enterprises. Read More more arrow

MedGadget’s MedTech Monday: Blind drivers coming to a street near you
Virginia Tech engineers develop a car for the blind; morphing liquid/gel material helps heal heart attacks; Epocrates’ iPhone app users top 100,000; a Microsoft Office-powered EMR system; and the VA tests a mobile medical information system. Read More more arrow

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First Swine Flu test nod goes to Quest Diagnostics

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The race to be the first to get a diagnostic test for Swine Flu to market tipped to Quest Diagnostics, after the Food & Drug Administration gave emergency use authorization to one of its subsidiary’s H1N1 influenza virus tests.

The Influenza A H1N1 (2009) Real Time RT-PCR test, made by Cypress, Calif.-based Quest unit Focus Diagnostics, is the first commercial lab test to win the emergency use nod from the FDA and the first to use Swine Flu RNA in nasal or throat samples to make the diagnosis, according to Quest. Turnaround time for the test is typically 24 hours, the company said.

The news is a blow to Waltham, Mass.-based Inverness Medical Innovations, London’s Osmetech (which has local operations in Maynard, Mass.) and Kansas City-based Evogen Inc. All three were hoping to have their Swine Flu tests win favor from the FDA.

It’s especially bitter medicine for Osmetech, which asked the FDA for emergency dispensation for its own molecular diagnostic for Swine Flu in May.

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  • MedAcuity advising Ventilator Project on software
    MedAcuity Software (Westford, Mass.) announced today that it has volunteered to provide technical software assessment for The Ventilator Project, a non-profit working on developing a low-cost ventilator specifically for COVID-19 patients. Founded in March 2020 by entrepreneur Tyler Mantel of Watertower Robotics, The Ventilator Project has built a team of more than 250 volunteers from… […]
  • Hologic applies for pooled COVID-19 testing nod
    Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing. Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July,… […]
  • Canon Medical launches mobile digital X-ray platform
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