IPO could bring in up to $1B for Acelity | Mitral valve device maker to be acquired by Medtronic in $458M deal | Calif. maker of spinal fusion devices gets $12M boost
 

August 27, 2015
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IPO could bring in up to $1B for Acelity
An initial public offering has been filed by Acelity that could pull in up to $1 billion. The San Antonio-based wound care firm intends to use the money to redeem senior notes that are due in 2019. MassDevice.com (Boston) (8/26)
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The Top 10 CE Marking Issues — How Can You Avoid Them?
2015 Medical Devices Roadshow
Learnthetop 10 CE Marking issues + how to avoid their costly missteps from the leading North American CE Marking reviewer. Plus, gain insight into advancing EU and ISO 13485 regulatory updates, usability and human factors + notified body change reporting at the 1-day Roadshow nearest you.
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Business & Market TrendsSponsored By
Mitral valve device maker to be acquired by Medtronic in $458M deal
Medtronic has agreed to a deal worth $458M to purchase Twelve, a Redwood City, Calif.-based medtech firm that is developing a device for transcatheter mitral valve replacement. The deal is likely to be wrapped up in October. American City Business Journals/San Jose, Calif. (8/26), CardiovascularBusiness.com (8/25), The Wall Street Journal (tiered subscription model) (8/25)
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Calif. maker of spinal fusion devices gets $12M boost
A funding round that includes a debt facility with Silicon Valley Bank brought in $12 million for Providence Medical Technology, a maker of spinal fusion devices in California. CEO Jeff Smith said the company is expanding its cervical fusion product line designed to treat cervical disorders that need surgery. MedCityNews.com (8/26)
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Funding round pulls in $2M for MocaCare
A Series A financing round led by JDM Mobile Internet Solutions has brought in $2 million for Palo Alto, Calif.-based MocaCare. The firm will use the proceeds to support the international and domestic release of its Mocaheart, a hand-held health monitor designed to measure metrics such as blood velocity, blood oxygen level and heart rate. MassDevice.com (Boston) (8/26)
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Seed funding round pulls in $500,000 for medtech startup
A round of seed financing has brought in $500,000 for Perceptive Navigation. The Baltimore medtech startup will use the proceeds to back efforts to secure FDA approval for its ultrasound device, which CEO Todd Chappell anticipates will happen late next year. American City Business Journals/Baltimore (8/26)
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Is your company's website a potential source for a product liability lawsuit?
Using legal principals and recent cases and development this prerecorded webinar addresses common mistakes that life sciences companies make on their websites. Including how plaintiffs can use your website content to make their cases and ways to avoid these risks. Read More.

Science & HealthSponsored By
U.S. patent for neurostimulation system issued to Mainstay Medical
Mainstay Medical has obtained a U.S. patent for its ReActiv8 technology, a neurostimulation device developed to address chronic low-back pain. BeckersSpine.com (8/26)
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Penn State's Master of Health Administration
Continuing your education with our online MHA program helps you do more than just keep up with this complex field. With your new degree, combining core healthcare and business management principles, you can prepare for challenging leadership positions in the constantly evolving world of healthcare. Learn More

Viewpoints on Innovation
Sponsored Content from Kalypso
Now That Your PLM Implementation is Done, How Will You Sustain ROI?
How much are you spending just to keep the lights on with your PLM solution? Get more value from PLM by outsourcing support and maintenance as managed services. Here are three key ways managed services can boost PLM ROI. Read this Viewpoint
 
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Four Behaviors that Fuel Innovation
Bad habits can negatively impact innovation. Instill these behaviors in your innovation teams to improve results and sustain them over time. Read this Viewpoint
 
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Emerging TechnologiesSponsored By
EU OKs fungal test, MDx platform from Renishaw
Regulators in Europe have given Renishaw Diagnostics the CE-IVD mark for its Fungiplex test, a PCR-based assay for analyzing blood samples to identify Aspergillus and Candida DNA. The company also obtained the CE-IVD mark for its RenDx Multiplex Assay System, which uses surface-enhanced resonance Raman spectroscopy to detect 12 Aspergillus and Candida fungal species. GenomeWeb Daily News (free registration) (8/26)
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Don't lose access to your customer's facility. We can help.
Rep-Clear: Watermark's Solution for ensuring access to your customers. Rep-Clear includes our proprietary platform for tracking all items associated with a Rep and our professional support staff to provide individual service, ensuring all items are up to date and access to a facility is not lost. View common rep excuses.

Government & RegulatorySponsored By
Chinese manufacturers face new device, drug rules
New rules from the China Food and Drug Administration will be implemented over the next few months and will affect medical device and drug manufacturers. The rules pertain to unannounced inspections, good manufacturing practice requirements, product classifications and clinical trial records. Clinica (subscription required) (8/25)
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FDA clearance sought by Luminex for respiratory pathogen test
Luminex has filed an application with the FDA seeking 510(k) clearance for its NxTAG Respiratory Pathogen Panel. The firm hopes to obtain clearance for the product, which uses a single closed-tube technology to simultaneously spot 21 respiratory pathogens, this year. GenomeWeb Daily News (free registration) (8/26)
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Cepheid receives FDA warning over manufacturing practices at Swedish facility
A warning letter was issued by the FDA to Cepheid over good manufacturing practice violations at its R&D and manufacturing facility in Solna, Sweden. The firm, which makes the Xpert Norovirus tests, said it is talking with the FDA about the issues and is taking steps to improve its documentation and procedures. GenomeWeb Daily News (free registration) (8/26)
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How well do you know Adaptive Web Design?
Retailers of all sizes are now realizing what giants like Amazon have known for years: that the ultimate mobile web solution blends the best of all available methods into an adaptive approach. In this whitepaper, we answer:
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Medical Technology Learning InstituteSponsored By
FDA Inspections, Warning Letters & CAPA Workshop
Sept. 1-2 | Washington, D.C.
This workshop will provide you with the tools to avoid warning letters, enable you to demonstrate your compliance initiatives and teach you how to respond to a warning letter. You'll learn how to properly integrate and implement your CAPA program to improve internal processes and products and better achieve business objectives. Learn more.
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Working with Private Payers: Advocating for Your Medical Technology in the Age of Reform
Nov. 12 | Washington, D.C.
Key payers, leading provider organizations and industry experts will highlight strategies for payer-provider negotiations, obtaining reimbursement for your company's technology and effective relations with payers during this one-day workshop. You'll walk away with the know-how to develop your private payer strategy. Learn more.
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Quality Professionals: Visit Library of Successful Quality Practices at AdvaMed.org
Along with FDA, AdvaMed believes that product quality goes beyond compliance with the current Quality System Regulation (21 C.F.R. Part 820). That's why AdvaMed and its members created the Library of Successful Quality Practices, providing a selection of current industry successful practices that can serve as a roadmap for companies seeking to improve their quality systems by leveraging proven industry methods. Visit the library.
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