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5/22/2017

Data from a midstage trial showed that AB Science's AB1010, or masitinib, administered at 4.5 mg/kg daily significantly slowed the progression of amytrophic lateral sclerosis in patients with a more slowly progressing form of the disease compared with placebo use, but it failed to perform significantly better against placebo in a broader patient population. AB Science expects a decision on its marketing authorization application for the drug from the European Medicines Agency in the fourth quarter of the year.

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BioCentury
5/22/2017

John Morrell has recalled over 210,000 pounds of Nathan's and Curtis brands of beef hot dogs after the company received three consumer complaints of contamination with metal pieces. Affected products in the recall include 14-ounce packages of Nathan's Skinless 8 Beef Franks and 16-ounce packages of Curtis Beef Master Beef Franks, with "use by" dates of Aug. 19 and June 15, respectively, and both with the establishment number EST. 296.

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Food Safety News
5/22/2017

The Early Warning Score system has been launched by Masimo for use with its Root patient monitoring and connectivity hub. The system is intended to help clinicians determine the potential degree of patient deterioriation by aggregating data from vital signs and clinical observations.

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MassDevice (Boston)
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Masimo
5/22/2017

Cardinal Health's interventional vascular arm, Cordis, unveiled at the annual EUROPCR conference its RAILWAY Sheathless Access System, a device designed to enable direct access to the radial artery for introducing intravascular devices. The company also introduced two Kaneka percutaneous transluminal coronary angioplasty balloon catheters, the Raiden3 system and the Ikazuchi Zero catheter, at the conference.

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MedGadget
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Cordis, EUROPCR
5/22/2017

European regulators have given Dutch company Ophtec CE mark approval for its Precizon Presbyopic intraocular lens, designed for treating presbyopia using continuous transitional zones. The device, which is tolerant of misalignment as the natural lens becomes unable to change shape, is expected to be released in October.

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FDAnews
5/22/2017

A public offering of 8,000 shares of Series B convertible preferred stock and related warrants has pulled in $8 million for Redwood City, Calif.-based Dextera Surgical. The proceeds will be used to support the development and sales of the company's MicroCutter 5/80 surgical stapler, as well as for general corporate functions.

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MassDevice (Boston)
5/22/2017

The Florida Institute for the Commercialization of Public Research has provided an undisclosed amount of funding to Alachua, Fla.-based Amend Surgical, a medtech company specializing in the improvement of the regenerative and healing capacity of bone grafts. The money will be used to support continued development and expansion.

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FinSMEs
5/22/2017

A 285,000-square-foot facility has been opened in Salt Lake City by BioMerieux's molecular diagnostics affiliate, BioFire Diagnostics, for the development of FilmArray, its PCR-based multiplex system designed to diagnose infectious diseases. The Alain Merieux Center for Molecular Diagnostics cost almost $100 million and employs over 1,000 people.

5/22/2017

Zimmer Biomet and Bonutti Research have reached a license agreement allowing Zimmer Biomet to use two patent families created by Dr. Peter Bonutti. Zimmer Biomet expects one of the patent families to enhance its Rosa robotic total knee application, which is being developed, and the other to strengthen its Persona The Personalized Knee System and the NexGen Complete Knee Solution.

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Becker's Spine Review
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Zimmer Biomet, Bonutti Research
5/22/2017

Stephen Lane has been tapped to serve as chief medical officer and global head of franchise clinical strategy at Alcon. Lane, a founding partner of Associated Eye Care, will take charge of the integration of clinical, scientific and commercial priorities across the surgical and vision care franchises of the company.

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Alcon, Stephen Lane, global head