Nanosphere seals debt facility with NSPH Funding, raises $4.4M in financing round | Smith & Nephew buys S2 Interactive's supply chain management solutions | Circassia to buy asthma device maker for $217M
May 18, 2015
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Nanosphere seals debt facility with NSPH Funding, raises $4.4M in financing round
A Series A financing round has brought in $4.4 million for Nanosphere. The money will be used by the firm as working capital and to support general corporate functions. A debt facility totaling $30 million was also sealed by the firm with NSPH Funding. GenomeWeb Daily News (free registration) (5/15)
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NEW VIDEO: How to get regulatory approval in Australia
Interested in learning how to start selling your medical devices in Australia? Emergo has put together this 4 minute animated video that clearly explains the TGA regulatory process and how long it takes to gain approval. Includes link to a process chart about Australia you can download. WATCH VIDEO NOW
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Smith & Nephew buys S2 Interactive's supply chain management solutions
Smith & Nephew recently bought S2 Interactive's TrayTouch and Virtual Backtable applications. The tools are designed to help ambulatory surgery facilities and hospitals manage their surgical supplies by allowing them to view, examine and oversee information about instrument use during surgery in real time. (5/15)
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Circassia to buy asthma device maker for $217M
Circassia Pharmaceuticals will pay about $217 million to purchase Aerocrine, maker of the Niox Mino, designed to detect fractional exhaled nitric oxide in patients' breath, which indicates airway inflammation and asthma. The deal's completion would support Circassia's release of the Cat-SPIRE next-generation allergy treatment. Clinica (5/15)
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Canon U.S. Life Sciences appoints new CEO, president
Canon U.S. Life Sciences has named Akiko Tanaka its president and CEO. Tanaka, who served as the company's COO and vice president before the appointment, was also tapped to become Canon BioMedical's CEO and president. GenomeWeb Daily News (free registration) (5/15)
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Webinar: Increase Market Share Using Medical Claims Data
Having the right intelligence can make a significant impact on sales and market share. Learn how medical device companies can leverage medical claims data to identify the right physicians and understand their referral networks to influence decisions and align sales. Click here to register for the free webinar
Science & Health
Medtronic reports positive trial results for antibacterial device
A clinical study showed promising results for Medtonic's TYRX antibacterial envelope, which releases antimicrobial agents to minimize infections after implantation of a cardiac implantable electronic device. The trial results showed that major surgical site infections were reduced by 80% for up to a year when the envelope was used. FDAnews (5/15)
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CVRx to launch U.S. trial for Barostim device
The FDA has given CVRx approval to conduct a pivotal trial for its Barostim device, designed for heart failure patients, in September. The approval came after an early study showed the device to be helpful in patients without cardiac resynchronization therapy devices. About 480 patients will participate in the pivotal trial, which will be held in 90 centers. (Boston) (5/15)
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FEATURED VIDEO: The Traits of Very Successful Leaders
Someone who is a good leader knows how to get work done, but a great leader is someone who inspires employees to do their best all the time. Linda Rottenberg, the co-founder and CEO of Endeavor, tells us about some common traits among successful leaders. Watch the video now.

Emerging Technologies
Wound dressing system released by Acelity in EU
The Nanova therapy system, developed by Acelity for dressing wounds, is now available in European markets. The product features negative pressure for slow-to-heal wounds and an exudate-retaining layer that eliminates the need for a fluid reservoir. FDAnews (5/15)
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Hot Topics
Government & Regulatory
Advisory panel meets to discuss duodenoscope reprocessing concerns
The FDA's Gastroenterology-Urology Devices Panel warned that cleaning and disinfecting duodenoscopes based on reprocessing recommendations does not give "reasonable assurance of safety and effectiveness" when the devices are used in endoscopic retrograde cholangiopancreatography. Sterilization of the devices was recommended by more than two-thirds of the panel, which met Thursday and Friday. Others said the current practice of high-level disinfection, if done properly, is effective. Most panelists called for innovations to the device's design to make cleaning easier, although none of the members said the risks associated with having a procedure using a duodenoscope exceeded the benefits. Family Practice News (5/16)
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Federal government develops reference material for DNA genetic testing
The U.S. National Institute of Standards and Technology has developed DNA reference material that medical laboratories can use to ensure the accuracy of genetic testing. For $450, the agency will provide 10 micrograms of DNA from a known subject for testing by scientists and laboratories. The New York Times (tiered subscription model) (5/14)
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HeartWare's heart-assist device kit recall labeled Class I by FDA
A recall initiated by HeartWare involving its ventricular assist system pump driveline splice kit has been categorized by the FDA as Class I. An urgent medical device corrective letter was released by the firm May 11 over concern that the kit will not work properly when exposed to excessive force. FDAnews (5/15)
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Medical Technology Learning Institute
AdvaMed's 2015 Payment Policy Conference: The Evolving Landscape for Medical Technologies
June 23-24 | Arlington, Va.
The current reimbursement and coverage landscapes for medical devices and the potential impact of changes in the environment on payers, health care providers and hospital systems will be discussed. We expect a host of speakers from providers, private insurance plans, device manufacturers, hospital systems, the Centers for Medicare and Medicaid Services and more. All individuals who work in the medical device payment and/or coverage spheres, whether working for a manufacturer, hospital system, insurance company or in another industry, will benefit from attending. Learn more.
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510(k) Submissions Workshop
Oct. 19-20 | Washington, D.C.
Industry experts and key personnel from the FDA CDRH 510(k) staff (invited) are coming together to discuss 510(k) submissions. Topics to be discussed include FDA updates to the 510(k) process, factors to consider when assembling a submission and more. Learn more.
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