Shareholders OK merger of Tornier, Wright Medical | Maker of heart-mapping device acquired by Medtronic in $93M deal | IPO pulls in about $47.8M for Invuity
June 22, 2015
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Shareholders OK merger of Tornier, Wright Medical
Shareholders on Thursday approved the proposed $3.3 billion merger of orthopedic device firms Wright Medical and Tornier. Under the deal, a combined board of directors will be elected, and Tornier will take the name of Wright Medical. Wright will base its upper extremities unit at Tornier's facility in Bloomington, Minn., its engineering in Warsaw, Ind., and its lower extremities and biologics unit at the Wright facility in Memphis, Tenn. The combined company will be led by Wright CEO Robert Palmisano, while Tornier CEO David Mowry will serve as COO and executive vice president. (Boston) (6/19)
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ISO 13485 and ISO 9001 - How Will the Changes to Both Impact Your Company?
ISO 13485's 3rd revision will not align with ISO 9001:2015. What will this mean for medical device manufacturers who hold both certifications? Get guidance on planning for the changes you'll need to make for both revisions + for developing transition plans to allow for a smooth migration. Register now
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Maker of heart-mapping device acquired by Medtronic in $93M deal
Medtronic has purchased Cleveland-based CardioInsight Technologies and its ECVUE electrocardiographic mapping system in a deal valued at $93 million. Medtronic cited a loan worth $25 million and a cash payment of $75 million as part of the deal. (Boston) (6/19)
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IPO pulls in about $47.8M for Invuity
Invuity brought in about $47.8 million in proceeds from its now-closed initial public offering that started June 15. The San Francisco-based maker of surgical lighting will use the proceeds to expand its sales and marketing as well as its research and development program. (Boston) (6/19)
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Yankee Alliance extends deal with Bacterin for biologic implants
A deal between Bacterin and Yankee Alliance, a group purchasing organization, has been extended through June 2018. The deal gives members of Yankee Alliance continued access to Bacterin's 3Demin cortical fiber allografts and other biologic implants. (6/19)
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Hologic appoints new board chairman, lead independent director
Steve MacMillan, president and CEO of Hologic, has been tapped to succeed David LaVance as board chairman at the company. In addition, Hologic chose director Elaine Ullian to serve as the company's lead independent director. GenomeWeb Daily News (free registration) (6/19)
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Pay HCPs…Not Penalties!
Receive invoices, process invoices, pay HCP, track payment, report payment, argue with HCP, issue 1099, perform due diligence…start again. Supporting HCP consultants and speakers can be a big task. Watermark has a turnkey solution to meet your needs, support you HCP, and keep you in compliance.

Science & Health
Teva partners with microchip drug-delivery company
Israel's Teva Pharmaceutical Industries will pay $35 million to Massachusetts-based Microchips Biotech, which makes implantable microchips that can deliver precise dosages over a period of months or years. The companies will begin by focusing on one area of disease, which they have not disclosed. BetaBoston (6/19), American City Business Journals/Philadelphia (6/18)
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Emerging Technologies
Self-expanding stent from Terumo debuts in U.S.
The Misago, a nitinol self-expanding stent designed to address peripheral artery disease in the proximal popliteal and superficial femoral arteries, has been launched by Japanese medtech firm Terumo in the U.S. The product was granted premarket approval by the FDA last month. FDAnews (6/22)
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Sorin's MRI-compatible pacemaker makes EU debut
The Kora 250 pacemaker has been released in Europe by Italian medtech firm Sorin Group. The device, which includes diagnostic and therapeutic features, allows patients to undergo full-body MRI scans for conditions such as stroke, cancer or arthritis. FDAnews (6/19)
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Hot Topics
Government & Regulatory
EU OKs cartridge, catheter kits for ALung's respiratory-assist device
Regulators in Europe have given ALung Technologies the CE mark for its Hemolung XG4 catheter and cartridge kits. The kits are designed for use with the firm's Hemolung respiratory-assist technology for acute respiratory failure patients. The products will be available next month in some markets in Europe. FDAnews (6/19)
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FDA labels Zimmer's hip prosthesis recall as Class I
A recall involving 64 lot numbers of Zimmer's M/L Taper Hip Prosthesis with femoral stems and necks has been categorized by the FDA as Class I. The recall was made over concerns about manufacturing residues on the products, which can result in serious adverse events such as infections, allergic reactions, pain or death. The FDA said Zimmer hasn't received complaints regarding the issue. (Boston) (6/19)
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Medical Technology Learning Institute
FDA Submissions Strategy Workshop
June 23-24 | AdvaMed office, Washington, D.C.
This two-day workshop is designed to prepare you for the development and execution of effective submission strategies for your Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs) and Premarket Notifications (510(k)s). This workshop is ideal for professionals in regulatory affairs, clinical affairs, research and development and quality assurance. Learn more.
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Integrating Human Factors into Medical Device Design Control and Beyond
July 14-15 | Washington, D.C.
You'll learn all aspects of design control, emphasizing how it interacts with other quality system elements and other company functions and when to build human factors into a development program with examples and group exercises. Regulatory affairs specialists, engineering managers, quality & production engineers, QA/Q directors and managers, compliance officers and those in medical operations and safety will benefit from attending. Learn more.
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