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March 5, 2013

News for medical technology professionals

Top Story

TranS1 boosts spinal device portfolio with Baxano buy
TranS1 has agreed to pay cash and company stock, plus $3 million in debt refinancing, to acquire Baxano in a deal set to be completed in the second quarter. Baxano, which develops the iO-Flex technology used in standard spinal decompression procedures, complements TranS1's mission to provide devices for treating degenerative spinal disease. American City Business Journals/Raleigh/Durham, N.C. (3/4)

Accenture helps Medical Equipment Technology (MET) companies drive growth using Supply Chain Visibility
Supply Chain Visibility plays a crucial role in the Medical Equipment Technology (MET) industry, enhancing patient safety and reducing compliance risks. The consequences of inadequate Supply Chain Visibility can be severe. Find out how MET companies can gain the edge by applying Supply Chain Visibility to their operations to drive value and growth.

Business & Market Trends

25 life sciences firms receive $25M in tax incentives in Mass.
A group of 25 biotech companies, including Biogen Idec, Nova BioMedical, PerkinElmer and Boston Heart Diagnostics, will receive more than $25 million in tax incentives from the Massachusetts Life Sciences Center. The incentives are intended to encourage the companies to promote job growth in the state. MassDevice.com (Boston) (3/4)

EnteroMedics raises about $12 million for obesity device
EnteroMedics has raised net proceeds of about $12 million in a public offering. The St. Paul, Minn.-based company will use the money to seek FDA approval for its Maestro RC system, which uses vagal nerve blocking to help treat patients with obesity, as well as to market the product outside the U.S. MassDevice.com (Boston) (3/4)

Analogic wraps up Ultrasonix Medical acquisition
Analogic has finalized its purchase of Ultrasonix Medical for about $83 million. Important ultrasound technology, products and sales channels will be added through the acquisition that will complement Analogic's ultrasound business, the company said. RTT News (3/4)

International Developments

EKF moves to make inroads in molecular Dx market
EKF Diagnostics has agreed to acquire 360 Genomics, which specializes in mutation detection technology, for $2.4 million worth of company stock and as much as $12.1 million in milestone cash payments. The deal will allow EKF to expand its point-of-care testing portfolio as well as make inroads in the molecular diagnostics arena. Clinica (subscription required) (3/4)

Brazil to allow foreign inspection of medtech import licensees
Brazil has expanded the role of its regulatory agency Anvisa to enable overseas inspections of medtech suppliers. The move is in response to criticism of the lengthy delays in license approvals experienced by as many as 5,000 domestic and 2,500 foreign firms. Clinica (3/4)

Science & Health

Trial begins for Endologix's aortic aneurysm device
Endologix is sponsoring a clinical study of its Ventana Fenestrated System, which features two branched stent grafts for maintaining blood flow in the kidneys and a main column to shield the aorta and prevent blood flow in the aneurysm. The FDA-approved trial will test whether the device is safe and effective in patients with pararenal and juxtarenal aortic aneurysms. American City Business Journals/Atlanta/A Healthy Conversation blog (2/28)

Emerging Technologies

Aesculap's device to treat hydrocephalus is available
The Miethke proSA shunt valve, designed to treat hydrocephalus, has been launched by Aesculap. The device can be used to control cerebrospinal fluid flow based on whether the patient is in a vertical or horizontal position, and doctors can either use the predetermined flow rates or adjust them with a compatible valve. MedGadget.com (3/4)

Government & Regulatory

FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan
LifeScan has received FDA approval for its OneTouch Verio Synch system, which is used to monitor blood glucose in diabetes patients. The technology uses Bluetooth connectivity to allow patients to wirelessly receive personalized data, including a 14-day summary of glucose test outcomes, via an iPad, iPhone or iPod touch. Healio/Endocrine Today (3/4)

Risk of brain damage prompts recall of Ad-Tech's subdural electrodes
Ad-Tech Medical Instrument is recalling its Macro Micro Subdural Electrodes that were produced between June 2006 and March 2012. The recall is prompted by concerns that the devices could trigger hemorrhage or brain damage that could result in infarction or seizures, according to an FDA notice. MassDevice.com (Boston) (3/4)

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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Position Title	Company Name	Location
Sales Area Manager/Sales Rep of Neurovascular Intervention Products	Asahi Intecc USA, Inc.	Any location in US, CA
Compliance Consultant 2	DJO Global	Vista, CA
Accreditation Manager	American Association of Tissue Banks	McLean, VA
REGULATORY AFFAIRS SPECIALIST	Masimo Corporation	Irvine, CA
Director, Health Care Compliance	RTI Biologics	Alachua, FL
Director of Global Infrastructure - 002196	Edwards Lifesciences	Irvine, CA
Manager, HCL Regulatory & Quality Compliance	Owens & Minor	Louisville, KY
DIR OPERATIONS, Milpitas Site - 130000007R	Abbott	San Jose, CA
Engineer, Process Development	ArthroCare Corporation	Irvine, CA
Biostatistician - Post Market Surveillance	Johnson & Johnson	Raynham, MA
Legal Counsel II	Medtronic, Inc.	Minneapolis, MN or Washington, DC, United States

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