Top Story

• Medtronic closes $816M buyout of Chinese orthopedic device firm
  Medtronic has wrapped up its purchase of China Kanghui Holdings, a Chinese maker of orthopedic devices, for $816 million. The deal allows Medtronic to strengthen its position in the Chinese orthopedics arena as well as potentially bolster its global orthopedics footprint, a Medtronic official said. American City Business Journals/Memphis, Tenn. (11/2)     

Business & Market Trends

• Cleveland HeartLab raises $14.7M for heart inflammation test
  Cleveland HeartLab has obtained $14.7 million in an equity funding round led by Mutual Capital Partners. Proceeds will go toward the company's CardioMPO assay, which is used for screening heart inflammation. MassDevice.com (Boston) (11/1)     

• Carestream announces Genesis Digital acquisition
  Carestream Health has agreed to buy Genesis Digital Imaging, which develops imaging software and supplies diagnostic imaging devices, for undisclosed terms. The deal will allow Carestream to add Genesis to its medical division and help broaden its footprint in the U.S. "value-tier" segment. BeckersASC.com (11/2), DOTMed.com (11/2)     

• Former HemoSphere exec takes the helm of CardioInsight
  Patrick Wethington has been tapped to serve as president and CEO of CardioInsight Technologies, which specializes in noninvasive electrocardiographic mapping systems. Wethington, who most recently worked at HemoSphere as president and CEO, replaces Steve Arless, who stepped down in April. MassDevice.com (Boston) (11/2)     

International Developments

• Group IDs 10 areas for harmonizing medtech regulations in Asia
  A list has been issued by the Asian Harmonization Working Party of 10 areas it views as having the "most potential for success" in promoting medtech regulatory convergence among its 23 member countries, starting with using a common definition for what is deemed a "medical device." The list is part of the group's proposed "Strategic Framework Towards 2020." Clinica (subscription required) (11/1)     

Science & Health

• Direct Flow reports positive trial results for aortic valve
  More than 95% of patients in a study of Direct Flow Medical's Transcatheter Aortic Valve System saw minimal or mild aortic regurgitation, while no patients had vascular complications. The device, which consists of bovine pericardium leaflets, a polymer frame and two inflatable rings, can be repositioned easily for improved fit or extracted if complications arise. MedGadget.com (11/2)     

Emerging Technologies

• Accuray scores FDA clearance for next-gen CyberKnife device
  The FDA has cleared Accuray to market the CyberKnife M6 Series, a next-generation line of the company's radiosurgery system. The company also secured 510(k) clearance for the InCise Multileaf Collimator, which is used to tailor an X-ray beam to the dimensions of a tumor, and is designed to work with the new FM and FIM CyberKnife models. DOTMed.com (11/2)     

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Hot Topics

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

• Cleveland Clinic releases list for top innovations for 2013 (The Plain Dealer (Cleveland))

• Thermedical wins FDA nod for tumor ablation system (Mass High Tech (Boston))

• NuVasive gets FDA OK for implantable cervical disc device (MassDevice.com (Boston))

• Calif. stroke device startup eyes an additional $3 million (MedCityNews.com)

• Neuromodulation device market poised to reach $7.07B in 6 years (MedCityNews.com)

• Results based on number of times each story was clicked by readers.

Industry Service Providers

• Wash. orthopedic facility adopts UMG/Del's X-ray technology
  Olympia Orthopaedic Associates in Olympia, Wash., has completed the deployment of five digital X-ray rooms from UMG/Del Medical. The sale and rollout, which is made in partnership with Del's authorized distributor Assured Imaging, included the company's new OTC12D radiographic line. AuntMinnie.com (free registration) (11/1)     

Government & Regulatory

• CMS seeks comments on new molecular Dx reimbursement scheme
  The new codes for molecular diagnostic tests released by the American Medical Association will be reimbursed under the CMS' clinical laboratory fee schedule starting Jan. 1, according to a final ruling, which is up for comment for 60 days. That portion pertaining to certain tests that need physician interpretation, however, will be covered under the physician fee schedule. GenomeWeb Daily News (free registration) (11/2)     

• Nanosphere gets moderate-complexity label for blood test
  Nanosphere has announced that the FDA has labeled its gram-positive blood culture nucleic acid test as a moderate-complexity test, allowing distribution to appropriate facilities. The test is capable of identifying the mecA, vanA and vanB genes, which can indicate resistance to vancomycin and methicillin/oxacillin antibiotics. GenomeWeb Daily News (free registration) (11/1)     

AdvaMed News

• Advertising and Promotion of Medical Devices
  Tuesday, Nov. 6 – Wednesday, Nov. 7
  Washington Marriott at Metro Center, Washington, D.C.
  Learn how to communicate your value without overstepping legal and regulatory boundaries. FDA staff, medical technology company leaders, legal experts and public affairs professionals will clarify the boundaries and the best practices for navigating these challenges. Our dialogue will include FDA and FTC regulations, risk management, the limits on label and advertising content, off-label use information, social media opportunities and challenges, promotion to providers and direct-to-consumer communications. Register for the workshop.     

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Position Title Company Name Location Director of Quality CEA Medical Manufacturing Colorado Springs, CO Associate Director, Regulatory Affairs Abbott Laboratories Santa Clara, CA Senior Marketing Communications Manager - Cardiac Surgery Systems - 001558 Edwards Lifesciences Irvine, CA Regulatory Affairs Associate Director Abbott Laboratories Santa Clara, CA Packaging Engineer/Project Leader Endologix, Inc. Irvine, CA Sr. Manager R & D, Systems Integration Engineering Abbott Laboratories Santa Ana, CA Physician Training Program Manager Endologix, Inc. Irvine, CA Director Clinical Research - Capnography Covidien Boulder, CO R&D Program Manager, New Product Development Spectranetics Colorado Springs, CO Post Market, CAPA, Internal Audit Manager Spectranetics Colorado Springs, CO Field Service Engineer IRIS International, Inc Sacramento, CA Quality Engineer IRIS International, Inc Chatsworth, CA Medical and Clinical Laboratory Technologist IRIS International, Inc Chatsworth, CA Senior Mechanical Engineer IRIS International, Inc Chatsworth, CA Clinical & Customer Care Specialist IRIS International, Inc Los Angeles, CA Developmental Cell Biologist/Biochemist IRIS International, Inc Carlsbad, CA Principal Systems Engineer IRIS International, Inc Chatsworth, CA Field Service Engineer IRIS International, Inc Providence, RI Director Professional Medical Education Covidien Boulder, CO REGULATORY AFFAIRS ENGINEER Welch Allyn Skaneateles, NY

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SmartQuote

Whoever is winning at the moment will always seem to be invincible." --George Orwell, British novelist and journalist