Abbott, St. Jude Medical to divest some assets for about $1.12B | AdvaMed launches purchasing-group benefit offering for members | For more:
October 19, 2016
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Abbott, St. Jude Medical to divest some assets for about $1.12B
St. Jude Medical and Abbott Laboratories on Tuesday announced they entered into an all-cash agreement with Japan-based Terumo to sell portions of their electrophysiology and vascular closure businesses for about $1.12 billion. The deal, which includes Abbott's Vado Steerable Sheath and St. Jude Medical's Angio-Seal and Femoseal vascular-closure products, is subject to the completion of Abbott's $25 billion merger with St. Jude and regulatory approvals.
Reuters (10/18),  The Wall Street Journal (tiered subscription model) (10/18) 
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Heart Valve Repair or Replacement?
Novella Clinical explores new device technologies and their influence on treatment options and clinical trials. Download this complimentary white paper: Innovations in Heart Valve Technology to learn more.
Business & Market Trends
AdvaMed launches purchasing-group benefit offering for members
AdvaMed has debuted a benefit offering called the AdvaMed Purchasing Group to leverage purchasing power and ensure that its member companies have access to high-quality services and products at reduced prices. The program is being offered in partnership with Biocom Purchasing Group.
Associations Now online (10/18) 
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J&J announces new Texas medical device innovation center
The Center for Device Innovation has been opened by Johnson & Johnson Innovation at the Texas Medical Center to advance the development of medical devices from concept to commercialization. The center, which will be led by cardiac surgeon and medical device entrepreneur William Cohn, will collaborate with medical centers to test devices for organ system diseases and will house a device engineering studio for an incubator program that will be launched in the third quarter of 2017.
Xconomy (10/18),  Houston Chronicle (tiered subscription model) (10/18) 
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Report predicts growth for worldwide medtech market
A report from market research firm Evaluate predicts the global medical device and technology market will reach almost $530 billion by 2022 with annual growth of at least 5%. Market players in the first half of this year also saw $17 billion in merger and acquisition activity, a drop of almost 80%, following a trend of mega deals in 2015, the firm said.
Forbes (10/17) 
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Report: Global neuromodulation market poised for growth
The worldwide neuromodulation market is expected to reach $5 billion by 2021 due to an expanding aging population, growing adoption of neuromodulation devices, increasing prevalence of neuromodulation-related diseases, technological advancements and a rise in global deals. Medtronic holds the largest share of the market, followed by Boston Scientific and St. Jude Medical. (10/18) 
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Science & Health
Trial begins for use of implant to treat congenital heart defects
A 50-patient pediatric clinical trial has been launched by St. Jude Medical to assess the effectiveness and safety of its AMPLATZER Duct Occluder II AS, a cardiac implant intended for treating patent ductus arteriosus using a pulmonary or aortic artery approach. The study will enroll at least 25 patients weighing more than 4.4 pounds and another 15 weighing 4.4 pounds or less. (Boston) (10/18), (10/18) 
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Emerging Technologies
Hemostasis clip debuted by Boston Scientific
Boston Scientific has announced the launch of its Resolution 360 hemostasis clip, a device intended for providing physicians with enhanced hemostatic clipping in endoscopy procedures. The device includes a multiwire braided catheter that allows the device to be rotated in controlled movements for a more precise clip placement.
FDAnews (10/18) 
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Ethicon announces launch of high-precision surgical shears
The Harmonic HD 1000i surgical shears have been launched by Johnson & Johnson subsidiary Ethicon for use in procedures involving complex thoracic, colorectal, hepato-pancreato-billary and gynecologic oncology. The high-precision devices come in a mechanical dissector-like shape and feature a tapered jaw to enhance precision in accessing tissue planes. (Boston) (10/18) 
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Government & Regulatory
Senators criticize FDA's program for reporting device-related adverse events
The FDA's retrospective summary reporting program for medical devices, which allows companies to report adverse events long after the normal 30-day reporting time frame following an incident, has been criticized by US senators from Minnesota for being at odds with public disclosure. AdvaMed defended the program, saying "retrospective analysis and potential reporting of events is appropriate and allowed by FDA for a variety of reasons including implementation of the company's quality management system."
Star Tribune (Minneapolis-St. Paul, Minn.) (10/18) 
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FDA clears Teleflex's midline catheter with Chlorag+ard Technology
The FDA has given Teleflex 510(k) clearance for its Arrow Midline catheter with Chlorag+ard Technology. The catheter minimizes common complications related to midline catheters and works with high-pressure injection for use in diagnostic studies.
FDAnews (10/18) 
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AdvaMed Events and Education
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C.
FDA (invited) and industry experts are coming together to teach you the basics of 510(k) submissions. You'll learn the FDA's updates to the 510(k) process, considerations for determining a product's regulatory route to market, factors to consider when planning and assembling a 510(k) submission, and tips and hints on interacting with the FDA during the 510(k) review process. Learn more.
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7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C.
From products to consumers to regulation and new media -- we're gathering industry practitioners to take a deep dive on the opportunities and challenges of product advertising. This annual conference will teach you how to communicate your value without overstepping legal and regulatory boundaries. FDA staff (invited), medical technology company leaders, legal experts and public affairs professionals will lead discussions. Learn more.
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