SynCardia gains FDA OK for portable artificial heart driver | Group looks to invest up to $60M in life sciences startups | Illumina buys companion Dx consulting firm
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July 17, 2014
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SynCardia gains FDA OK for portable artificial heart driver
The FDA has granted SynCardia Systems approval to market the Freedom driver for use with the company's Total Artificial Heart. The portable driver, which already has marketing approval in Canada and Europe, allows clinically stable patients implanted with the company's Total Artificial Heart to leave the hospital while awaiting a transplant. Arizona Daily Star (Tucson) (7/16)
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Learn How Analytics Outsourcing Can Become a Competitive Advantage
You've heard it before: outsourcing your analytics can improve customer segmentation, pinpoint cross- and upselling opportunities, and find new ways to deliver value--and do so more efficiently and effectively. Yet few med device companies do this today. However, a reticence to outsource analytics may prove to be a strategic blunder in the coming years. View this video to learn how analytics outsourcing can be a competitive advantage for your company.
Business & Market Trends
Group looks to invest up to $60M in life sciences startups
A fund worth as much as $60 million is being raised by the New York City Economic Development Corp. in an effort to foster biotech innovation in the city. The group plans to invest the money in early-stage companies developing diagnostics, medical devices and other life sciences technologies. Xconomy/New York (7/16)
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Illumina buys companion Dx consulting firm
Illumina has agreed to pay an undisclosed sum to purchase Myraqa, which provides regulatory and quality consulting services related to companion diagnostic tests. Illumina said the deal will strengthen its "in-house capabilities for clinical readiness and help prepare [the firm] for its next growth phase in regulated markets." GenomeWeb Daily News (free registration) (7/16), San Diego Business Journal (7/16)
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Medbio breaks ground on $3.39M facility expansion in Mich.
Medbio has initiated a project to expand its production and warehouse facility in Cascade Township, Mich. The Michigan Strategic Fund is providing tax breaks and a performance-based grant worth $180,000 for the project, which is expected to cost $3.39 million. The expansion could generate 45 new positions in the area in the next three years. (Michigan) (free registration) (7/16)
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International Developments
Report: Global medical polymer market could hit $7.05B by 2020
The growing use of high performance polymers to replace metal and glass in medical devices could help the worldwide medical polymer market hit $7.05 billion in six years, according to a Grand View Research report. North America dominated the market last year, but Asia is likely to play a key role in increasing medical polymer demand through 2020. Plastics & Rubber Weekly (U.K.) (7/16)
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Industry Insight
Podcast: Medical device execs discuss M&A activity
MassDevice speaks to 3M's Deb Rectenwald, St. Jude Medical's Philip Ebeling and Nadim Yared, CEO of CVRx, about the environment for medtech M&A and other trends affecting the industry. Listen to the podcast.
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Science & Health
BioTheranostics gets OK to distribute breast cancer Dx in N.Y.
BioTheranostics has received the go-ahead to distribute its Breast Cancer Index in New York. The molecular diagnostic assay measures a patient's risk of recurrent estrogen receptor-positive breast cancer and determines whether extended endocrine treatment will benefit the patient. GenomeWeb Daily News (free registration) (7/16)
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Emerging Technologies
Covidien's soft tissue ablation device could hit market in Q3
Covidien said its Emprint system, which was cleared by the FDA in April, could be available commercially in the third quarter. The device is intended to ablate diseased soft tissue in the lung, kidney and liver using the company's Thermosphere technology. (Boston) (7/16)
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Cartilage allograft kit from RTI debuts at conference
A device used for osteochondral allograft resurfacing was introduced by RTI Surgical at a recent sports medicine conference in Seattle. The Precision Allograft Cartilage Kit employs a surgical technique that supports enhanced accuracy and reduced cartilage trauma. (7/16)
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Government & Regulatory
DorsaVi's activity-monitoring device lands FDA clearance
The FDA has cleared dorsaVi to market its ViMove system for use in clinical settings or athletic training. The technology uses sensors to monitor muscle activity and movement, and wirelessly sends those readings to a computer for evaluation by physicians. (7/16)
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FDA clears IBA's compact gantry for proton therapy device
Ion Beam Applications has been cleared by the FDA to market its Compact Gantry Beam Line, which will be integrated with the company's ProteusOne device used for single-room proton therapy. (free registration) (7/16)
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AdvaMed News
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for Medical Technology Professionals. The ARCC Program is a relevant and timely collaboration between AdvaMed and UL EduNeering that helps medical technology professionals to expand their knowledge of quality, regulatory and compliance topics. Learn more.
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Who's Hiring?
Position TitleCompany NameLocation
Regulatory Affairs SpecialistBecton DickinsonFranklin Lakes, NJ
MGR CLINICAL RESEARCH - 14000003MBAbbottSanta Clara, CA
Director of Clinical Research Regenesis Biomedical, Inc.Scottsdale, AZ
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-- Margaret Wheatley,
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