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The first Swine Flu test nod goes to Quest Diagnostics

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The MassDevice Weekly Roundup brings you the latest medical device news and information.

News

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

Kinetic 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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The MassDevice Guide to Gift Bans

The Massachusetts gifts ban went into effect July 1. That means life science companies doing business in the Commonwealth, including medical device makers, must comply with its stringent regulations governing any gifts or payments to physicians. Click here for our guide to complying with these stringent new regulations. Read More more arrow

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Features

MassDevice Q&A: Thomas Taylor
The president of Roush Life Sciences and incoming MassMEDIC chairman on his deep ties to the Michigan auto industry and why you should always listen to your mother. Read More more arrow

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Blogs

MassDevice blog: Unhealthy alliance?
The SEIU and Wal-Mart join forces to push for requiring employers to provide health insurance for their workers, in an unlikely partnership between organized labor and one of its (formerly?) most implacable foes. Read More more arrow

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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The MassDevice Q&As: Voices of an Industry

The MassDevice Q&A page features a collection of free-form question-and-answer sessions with the executives, thought leaders and politicos driving this incredible industry. We do our best to find engaging people and let them speak for themselves about a wide range of topics affecting the medical device industry. Read More more arrow

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Medical Development Group Event

Wireless interference in the clinical environment
Technology changes rapidly, but nowhere does it change as rapidly as in healthcare. The convergence of multiple wireless technologies with the need for “better, cheaper, faster” healthcare is driving the evolution of medical devices (along with healthcare in general) in directions and speeds never seen before. Learn more Wed., July 29 at 5:30 p.m., at the MDG/AVNET Summer Educational event. 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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  • Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race
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  • How LimFlow’s foot-saving system prevents amputations in patients with no other options
    LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD). For CLTI patients who have lost blood flow below their knee and have no other suitable endovascular or surgical treatment options available, the LimFlow System for Transcatheter… […]
  • Device strategies to prevent healthcare-associated infections
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  • MGS breaks ground on innovation and tech center
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  • Two-armed surgical robot prototype targets pediatric brain tumors
    Researchers say they’ve developed a surgical robot for removing brain tumors in children, and that it could also offer a less invasive, safer option for adult neurosurgery and other procedures. The trick is using hollow, nitinol robot arms to allow neurosurgeons to swap tools during a tumor resection procedure, said Pierre DuPont. He’s the chief… […]
  • S3 Connected Health joins DiMe’s International Regulatory Pathways project
    NEWS RELEASE: S3 Connected Health joins DiMe’s team of digital health experts in their new project ‘International Regulatory Pathways’ DUBLIN, September 19, 2023 – Building on the success of the Digital Health US Regulatory Pathways, DiMe has assembled a global team of digital health experts, including S3 Connected Health, to support digital health product developers… […]
  • Four steps medtech startups can’t put off
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  • How Biosense Webster aims to expand access to AFib care
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  • Tessy Plastics announces CEO and president transitions
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  • Accumold details injection molding of thin wall cannulas
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