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    [title] => Tessy Plastics Acquires Automation and Tool Shops 
    [short_title] => 
    [summary] => Firm brings NuTec Automation Solutions and Custom Tool & Design Inc. into the fold. 
    [slug] => tessy-plastics-acquires-automation-and-tool-shops
    [body] => Tessy Plastics Corp. has announced their strategic acquisitions of NuTec Tooling Systems Inc. located in Meadville, Pa., and Custom Tool & Design (CTD) headquartered in Erie, Pa. The terms of both acquisitions were not disclosed.
 
NuTec, founded in 1983, has had a promising partnership with Tessy for over 15 years. With this acquisition, Tessy Plastics will have increased capabilities to support customer needs by providing state-of-the-art custom robotic automation and assembly solutions. Tessy Plastics and NuTec will continue to prosper as a team and provide superior quality, support, and strategic pricing.
 
Tessy Plastics plans to maintain the 62 jobs that currently reside in Meadville, Pennsylvania. Tessy Plastics President, Roland Beck, proudly states, “We look forward to partnering with NuTec as they have always done great work for us. Providing the highest quality to our customers is what matters the most to us. Having our own automation shop will allow for more efficient production, innovation, and detailed quality control. We are very excited to work with NuTec and look forward to upcoming projects.”
 
Custom Tool & Design (CTD), is a full scale injection mold manufacturer founded in 1971. CTD utilizes more than 45 years of experience to design and build high-volume plastic injection molds for consumer products and medical markets. They focus on innovation, education and quality while taking a proactive approach toward the future of the mold building industry. “CTD will allow Tessy to expand our expertise in tool manufacturing and supply highly technical injection molds directly to our customers. We will be able improve our costs, shorten our lead-times, and enhance our production support to our customers” said Tessy’s Vice President of Engineering, Stafford Frearson.
 
Through these acquisitions, Tessy is demonstrating their commitment to continually expanding their competencies in an effort to provide their customers with admirable contract manufacturing solutions. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-04-04 09:09:00 [updated_at] => 2019-04-04 09:17:15 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302054","311378","300397","310425","306449","306018","239550","306934","307494","300633","303912","114820","164158","179477","115044"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2019-04-04/tessy-plastics-acquires-automation-and-tool-shops/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300397 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"NeuMoDX Molecular Inc.","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176366 [primary_image_old] => 0 [slider_image_id] => 176366 [banner_image] => 0 [title] => QIAGEN, NeuMoDx Partner to Offer Next-Generation Systems for Molecular Diagnostic Testing [short_title] => [summary] => QIAGEN to launch two Sample to Insight systems in Europe and other markets. [slug] => qiagen-neumodx-partner-to-offer-next-generation-systems-for-molecular-diagnostic-testing [body] => QIAGEN N.V. and NeuMoDx Molecular Inc. have announced a strategic partnership to commercialize two new fully integrated systems for automation of PCR (polymerase chain reaction) testing. These next-generation systems are specifically designed to help clinical molecular diagnostic laboratories process increasing test volumes and deliver more rapid insights on a broad range of diseases.
 
Under the agreement, QIAGEN will initially distribute the NeuMoDx 288 (high-throughput version) and NeuMoDx 96 (mid-throughput version) in Europe and other major markets worldwide outside of the United States. NeuMoDx will cover the United States directly. The two companies have also entered into a merger agreement under which QIAGEN can acquire all NeuMoDx shares not currently owned by QIAGEN at a predetermined price of approximately $234 million (QIAGEN currently owns about 19.9 percent of NeuMoDx), subject to the achievement of certain regulatory and operational milestones.
 
QIAGEN intends to begin commercialization of the NeuMoDx systems with an initial assay menu based on the first two CE-IVD marked assays for Group B Streptococcus(GBS) and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) infections. The NeuMoDx systems offer a growing menu of relevant in-vitro diagnostic (IVD) tests and the ability to process both commercial and laboratory-developed tests (LDTs) in the most flexible and efficient manner. LDTs, which account for an important number of test requests and volumes, are IVD tests designed by clinical labs for their own use.
 
“Molecular diagnostic labs are demanding a true next generation of solutions for molecular diagnostic testing with features such as full automation, fast turnaround time, scalability, cost efficiency and ease of use,” said Peer M. Schatz, CEO of QIAGEN N.V. “The NeuMoDx approach delivers on this promise to customers with simpler and much faster workflows on more compact and versatile systems. It brings the simplicity of established clinical chemistry automation to molecular diagnostics along with rapid turnaround time in about an hour and promises massive sample processing capacity and a broad menu of tests. Together with QIAsymphony, QIAstat-Dx and GeneReader, the addition of NeuMoDx will enable QIAGEN to offer complementary systems that create an unparalleled portfolio of platforms for molecular diagnostics labs worldwide— addressing all key segments. We are determined to expand on our leadership position by offering solutions for use in every molecular diagnostics laboratory worldwide.”
 
“We are excited about joining forces with QIAGEN to take NeuMoDx to the next level on a global basis. These new solutions for molecular diagnostics, along with a rich menu of tests under development, will deliver real benefits to central laboratories, hospitals and the patients they serve,” said Jeff Williams, chairman and CEO of NeuMoDx Molecular. “This agreement with QIAGEN is an important recognition of the excellence of our NeuMoDx team, our achievements in developing the platform and the work we continue to do. We begin this collaboration by launching the NeuMoDx systems and initial assays, and the relationship will deepen as we achieve additional development and commercialization milestones.”
 
The NeuMoDx systems possess many key features that differentiate them from other laboratory-based PCR diagnostics systems. Most importantly, the NeuMoDx systems have the distinction of fully integrated operation, including performing every step from sample extraction through detection and results reporting. The addition of these systems strengthens QIAGEN’s portfolio of molecular testing platforms to address laboratory needs in almost any setting for molecular diagnostics.
  NeuMoDx Molecular, based in Ann Arbor, Mich., designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories. Its patented platforms offer ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve.
 
QIAGEN N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain molecular insights from samples containing the building blocks of life. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN  provides solutions to more than 500,000 customers around the world in molecular diagnostics (human healthcare), applied testing (primarily forensics), pharma (pharma and biotech companies) and academia (life sciences research). As of June 30, 2018, QIAGEN employed approximately 4,800 people in over 35 locations worldwide. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-18 09:07:00 [updated_at] => 2018-10-18 09:31:30 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["284483","299278","282557","289764","299755","300281","278927","290992","289956","289792","283612","278619","299739"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300633 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"GlobeNewswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176574 [primary_image_old] => [slider_image_id] => 176574 [banner_image] => 0 [title] => FDA Approves Medtronic's Valiant Navion Thoracic Stent Graft System [short_title] => [summary] => Next-generation thoracic endovascular repair (TEVAR) device expands applicability to a broader range of patients. [slug] => fda-approves-medtronics-valiant-navion-thoracic-stent-graft-system [body] => Medtronic plc announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).
 
Until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR) or required adjunctive procedures to accommodate calcification and tortuosity concerns. Valiant Navion allows for the potential for more patients to receive a percutaneous procedure and overcome these anatomical concerns, enabling a less invasive approach to treatment compared to surgical cut-down (open) procedures.
 
"Our focus at Medtronic continues to be on advancing the treatment of complex aortic disease to improve outcomes and extend life," said John Farquhar, vice president and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic. "This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair. This therapy is truly a testament to our more than 20 years of clinical and engineering insights, and we look forward to making it available to those in need."
 
The Valiant Navion system is a lower-profile evolution of the market-leading Valiant Captivia(TM) thoracic stent graft system, which has treated more than 100,000 patients globally. Valiant Navion is built on the design philosophy of the Valiant Captivia system for improved performance and increased patient applicability. The system also features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, providing physicians with two graft options to treat varying patient anatomies and pathologies.
 
"A significant reduction of the delivery system profile enables physicians to better facilitate the endovascular treatment of patients with smaller, tortuous, and calcified access vessel arteries," said Ali Azizzadeh, M.D., the U.S. principal investigator for the Valiant Navion IDE study. "Furthermore, the challenging anatomical and comorbid baseline characteristics and resulting clinical evidence of the global investigational device exemption (IDE) subjects support this design."
 
Approval was based on 30-day primary endpoint analysis of 87 subjects consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in subjects with TAA and PAU. The study included a challenging real-world patient population with 37.9 percent female enrollment and 71.3 percent subjects with severe to life-threatening systemic disease (ASA physical status classification III/IV). The results demonstrated efficacy, with:
   
The majority of procedures (50.6 percent) were performed through a percutaneous access approach, leading to operational efficiency with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.
 
Through 30 days, data showed low rates of peri-operative mortality at 2.3 percent (2/87) and secondary procedures at 2.3 percent (2/87). The rate of Type Ia endoleaks was 1.2 percent (1/87) at one-month imaging follow-up.
 
Approximately six out of 100,000 people globally experience a thoracic aortic aneurysm (TAA), a blood-filled bulge or ballooning of the aorta that runs through the chest and can lead to a life-threatening rupture and hemorrhage if not treated. Most people with TAA do not have any symptoms; however, risk factors include smoking, obesity, heredity, injury, or other disease.
 
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-23 10:18:00 [updated_at] => 2018-10-23 10:22:37 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300284","290459","288913","287984","287964","284494","284487","284246","283959","283697","281299","280635","282688","300250","279015","282390","296562","282544","282670"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302054 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2754 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Staff","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177730 [primary_image_old] => [slider_image_id] => 177730 [banner_image] => 0 [title] => 5 Questions from the Booth: Nelipak Healthcare Packaging [short_title] => [summary] => Digital sketching capabilities bring packaging concepts to life in a rapid and effective way. [slug] => 5-questions-from-the-booth-nelipak-healthcare-packaging [body] => The editorial team members of Medical Product Outsourcing and Orthopedic Design & Technology reached out to representatives at several companies exhibiting at Medica/Compamed this year in case you are unable to see them at the event or are not headed to Germany this year. Hopefully, the following questions we served up to Sean Egan, director of global marketing at Nelipak Healthcare Packaging, will offer you some additional insight to determine if the company is a potential services partner for you.
 
MPO: What technology or service are you emphasizing at Medica this year?
Sean Egan: We will be highlighting our digital sketching techniques with designers at the booth demonstrating how the process quickly captures customer input in the design process.
 
MPO: What’s the most common challenge customers inquire about and how do you address it?
Egan: Cost is an ongoing challenge as OEMs react to downward pressure from healthcare providers. While reducing material thickness in the package seems the obvious choice, this is not always the best option given the potential to introduce risk to the protective properties of the package around the product. Better design and incorporating features that make the package part of the procedure go towards reducing total cost of ownership of the tray. The second increasingly common challenge is reduction of material waste, as companies become more aware of playing their part in the circular economy to recycle more hospital healthcare plastics.
 
MPO: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Egan: Work with a partner who understands the industry, materials, regulations, and customer needs with the ability to bring value add to projects in terms of technical know-how and manufacturing reach.
 
It is particularly important to ensure manufacturing partners have the scale and footprint to maintain operations across more than one site. In today’s global operations, OEMs cannot afford to have lines down because a critical operation is dependent on a sole trader operations—this may seem obvious, but many companies have found themselves in this position.
 
MPO: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Egan: Technical expertise and range of equipment coupled with finishing services that provide value add for packaging solutions uniquely position Nelipak to meet customer needs, allowing them to concentrate on their core competencies of device design. Our three design centers and seven manufacturing sites across the Americas and Europe mean we are close to our customers’ facilities with the ability to develop projects within their time zone and reduce their shipping and warehousing needs.
 
MPO: In what ways is your company able to aid in getting a product (project) to market faster?
Egan: Nelipak’s approach to digital sketching kicks off projects faster by providing concept drawings in a couple of days—sometimes even hours—depending on the nature of the project. This allows packaging engineers to share ideas with non-technical people such as surgeons/marketeers who do not read technical drawings. Use of 3D rapid printed concept prototype molds allow for sample shots of small trays/blisters in specified materials, while the technology enables sampling of novel hold features before committing to full tool sets. Simulation provides analysis of material flow and product integrity testing to predict packaging performance before spending time and money on production tools.
 
Nelipak Healthcare Packaging is located at Medica/Compamed in Hall 8B, Booth/Stand J17. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-12 01:00:09 [updated_at] => 2018-11-11 04:53:23 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302033","302063","302050","302025","302036","302048","302068","302037","24946","282671","28830","289738","293035","264716"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306018 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Bally Ribbon Mills","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181039 [primary_image_old] => [slider_image_id] => 181039 [banner_image] => 0 [title] => Bally Ribbon Mills Receives ISO 13485:2016 Certification [short_title] => [summary] => Recertification reflects commitment to supplying highest quality medical products. [slug] => bally-ribbon-mills-receives-iso-134852016-certification [body] => Bally Ribbon Mills (BRM), a company involved in the design, development, and manufacture of highly specialized engineered woven fabrics, announces the company has received ISO 13485:2016 certification. ISO 13485 is the rigorous international standard that governs the design and manufacture of medical devices. BRM passed a surveillance audit with zero non-conformances.
 
For over 50 years, BRM has been supplying the highest quality medical products to its customers. BRM meets the ISO 13485 standards for medical devices by focusing on risk management and design control during product development and by manufacturing its products in a controlled work environment. In addition, BRM follows specific requirements for inspection and traceability for implantable devices as well as for verification of the effectiveness of corrective and preventive actions.
 
BRM’s facility includes advanced weaving systems, yarn preparation, and inspection areas for the production of fabric to the most stringent requirements. Environmental sampling, data collection, storage, and alarms ensure complete environmental monitoring and redundancies.
 
Quality efforts also include an emphasis on continuous improvement and defect prevention. Tools include but are not limited to Management and Feasibility Reviews, AS9102 First Articles, FMEA’s, Control Plans, IQ-OQ-PQ’s, Process/Product Validation and Lean/Six Sigma best practices.
 
For more information, visit https://www.ballyribbon.com/medical-textiles. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-17 14:45:00 [updated_at] => 2019-01-17 14:50:21 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305426","290459","293302","300633","288913","297040","30673","289768","299791","303213","305604","293267","301700","305414","294811"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306449 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2613 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181499 [primary_image_old] => [slider_image_id] => 181499 [banner_image] => 0 [title] => High Pressure Braided Tubing [short_title] => [summary] => The highest quality high pressure braided tubing for vascular balloon inflation, contrast injection and vacuum procedures. [slug] => high-pressure-braided-tubing [body] =>
Test And Analytical Capabilities
 
• Superior pressure decay properties
 
• Nitrogen pressure testing at 35 atm
 
• Burst pressure exceeding 1800 PSI
 
• Constant working pressure of 1200 PSI
 
• Impulse burst test
 
• Water leak decay
 
• Vacuum leak decay
 
• Negative pressure test


HPBT Assemblies Via UV & Solvent Bonding
 
• Suction connector
 
• Fixed male & female luer locks
 
• Male rotating union
 
• Additional components available upon request


Medical Device Applications
 
• Contrast media injection
 
• Inflation tubing
 
• Vacuum procedures
 
• Bone cement injection
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-24 10:04:00 [updated_at] => 2019-02-20 08:18:40 [last_updated_author] => 348682 [uploaded_by] => 0 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301768","306018","239550","306934","307494","293302","300633","299795","303174","303203","305056","300468","304174","295990"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300397 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"NeuMoDX Molecular Inc.","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176366 [primary_image_old] => 0 [slider_image_id] => 176366 [banner_image] => 0 [title] => QIAGEN, NeuMoDx Partner to Offer Next-Generation Systems for Molecular Diagnostic Testing [short_title] => [summary] => QIAGEN to launch two Sample to Insight systems in Europe and other markets. [slug] => qiagen-neumodx-partner-to-offer-next-generation-systems-for-molecular-diagnostic-testing [body] => QIAGEN N.V. and NeuMoDx Molecular Inc. have announced a strategic partnership to commercialize two new fully integrated systems for automation of PCR (polymerase chain reaction) testing. These next-generation systems are specifically designed to help clinical molecular diagnostic laboratories process increasing test volumes and deliver more rapid insights on a broad range of diseases.
 
Under the agreement, QIAGEN will initially distribute the NeuMoDx 288 (high-throughput version) and NeuMoDx 96 (mid-throughput version) in Europe and other major markets worldwide outside of the United States. NeuMoDx will cover the United States directly. The two companies have also entered into a merger agreement under which QIAGEN can acquire all NeuMoDx shares not currently owned by QIAGEN at a predetermined price of approximately $234 million (QIAGEN currently owns about 19.9 percent of NeuMoDx), subject to the achievement of certain regulatory and operational milestones.
 
QIAGEN intends to begin commercialization of the NeuMoDx systems with an initial assay menu based on the first two CE-IVD marked assays for Group B Streptococcus(GBS) and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) infections. The NeuMoDx systems offer a growing menu of relevant in-vitro diagnostic (IVD) tests and the ability to process both commercial and laboratory-developed tests (LDTs) in the most flexible and efficient manner. LDTs, which account for an important number of test requests and volumes, are IVD tests designed by clinical labs for their own use.
 
“Molecular diagnostic labs are demanding a true next generation of solutions for molecular diagnostic testing with features such as full automation, fast turnaround time, scalability, cost efficiency and ease of use,” said Peer M. Schatz, CEO of QIAGEN N.V. “The NeuMoDx approach delivers on this promise to customers with simpler and much faster workflows on more compact and versatile systems. It brings the simplicity of established clinical chemistry automation to molecular diagnostics along with rapid turnaround time in about an hour and promises massive sample processing capacity and a broad menu of tests. Together with QIAsymphony, QIAstat-Dx and GeneReader, the addition of NeuMoDx will enable QIAGEN to offer complementary systems that create an unparalleled portfolio of platforms for molecular diagnostics labs worldwide— addressing all key segments. We are determined to expand on our leadership position by offering solutions for use in every molecular diagnostics laboratory worldwide.”
 
“We are excited about joining forces with QIAGEN to take NeuMoDx to the next level on a global basis. These new solutions for molecular diagnostics, along with a rich menu of tests under development, will deliver real benefits to central laboratories, hospitals and the patients they serve,” said Jeff Williams, chairman and CEO of NeuMoDx Molecular. “This agreement with QIAGEN is an important recognition of the excellence of our NeuMoDx team, our achievements in developing the platform and the work we continue to do. We begin this collaboration by launching the NeuMoDx systems and initial assays, and the relationship will deepen as we achieve additional development and commercialization milestones.”
 
The NeuMoDx systems possess many key features that differentiate them from other laboratory-based PCR diagnostics systems. Most importantly, the NeuMoDx systems have the distinction of fully integrated operation, including performing every step from sample extraction through detection and results reporting. The addition of these systems strengthens QIAGEN’s portfolio of molecular testing platforms to address laboratory needs in almost any setting for molecular diagnostics.
  NeuMoDx Molecular, based in Ann Arbor, Mich., designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories. Its patented platforms offer ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve.
 
QIAGEN N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain molecular insights from samples containing the building blocks of life. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN  provides solutions to more than 500,000 customers around the world in molecular diagnostics (human healthcare), applied testing (primarily forensics), pharma (pharma and biotech companies) and academia (life sciences research). As of June 30, 2018, QIAGEN employed approximately 4,800 people in over 35 locations worldwide. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-18 09:07:00 [updated_at] => 2018-10-18 09:31:30 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["284483","299278","282557","289764","299755","300281","278927","290992","289956","289792","283612","278619","299739"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300633 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"GlobeNewswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176574 [primary_image_old] => [slider_image_id] => 176574 [banner_image] => 0 [title] => FDA Approves Medtronic's Valiant Navion Thoracic Stent Graft System [short_title] => [summary] => Next-generation thoracic endovascular repair (TEVAR) device expands applicability to a broader range of patients. [slug] => fda-approves-medtronics-valiant-navion-thoracic-stent-graft-system [body] => Medtronic plc announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).
 
Until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR) or required adjunctive procedures to accommodate calcification and tortuosity concerns. Valiant Navion allows for the potential for more patients to receive a percutaneous procedure and overcome these anatomical concerns, enabling a less invasive approach to treatment compared to surgical cut-down (open) procedures.
 
"Our focus at Medtronic continues to be on advancing the treatment of complex aortic disease to improve outcomes and extend life," said John Farquhar, vice president and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic. "This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair. This therapy is truly a testament to our more than 20 years of clinical and engineering insights, and we look forward to making it available to those in need."
 
The Valiant Navion system is a lower-profile evolution of the market-leading Valiant Captivia(TM) thoracic stent graft system, which has treated more than 100,000 patients globally. Valiant Navion is built on the design philosophy of the Valiant Captivia system for improved performance and increased patient applicability. The system also features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, providing physicians with two graft options to treat varying patient anatomies and pathologies.
 
"A significant reduction of the delivery system profile enables physicians to better facilitate the endovascular treatment of patients with smaller, tortuous, and calcified access vessel arteries," said Ali Azizzadeh, M.D., the U.S. principal investigator for the Valiant Navion IDE study. "Furthermore, the challenging anatomical and comorbid baseline characteristics and resulting clinical evidence of the global investigational device exemption (IDE) subjects support this design."
 
Approval was based on 30-day primary endpoint analysis of 87 subjects consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in subjects with TAA and PAU. The study included a challenging real-world patient population with 37.9 percent female enrollment and 71.3 percent subjects with severe to life-threatening systemic disease (ASA physical status classification III/IV). The results demonstrated efficacy, with:
   
The majority of procedures (50.6 percent) were performed through a percutaneous access approach, leading to operational efficiency with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.
 
Through 30 days, data showed low rates of peri-operative mortality at 2.3 percent (2/87) and secondary procedures at 2.3 percent (2/87). The rate of Type Ia endoleaks was 1.2 percent (1/87) at one-month imaging follow-up.
 
Approximately six out of 100,000 people globally experience a thoracic aortic aneurysm (TAA), a blood-filled bulge or ballooning of the aorta that runs through the chest and can lead to a life-threatening rupture and hemorrhage if not treated. Most people with TAA do not have any symptoms; however, risk factors include smoking, obesity, heredity, injury, or other disease.
 
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-23 10:18:00 [updated_at] => 2018-10-23 10:22:37 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300284","290459","288913","287984","287964","284494","284487","284246","283959","283697","281299","280635","282688","300250","279015","282390","296562","282544","282670"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302054 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2754 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"MPO Staff","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177730 [primary_image_old] => [slider_image_id] => 177730 [banner_image] => 0 [title] => 5 Questions from the Booth: Nelipak Healthcare Packaging [short_title] => [summary] => Digital sketching capabilities bring packaging concepts to life in a rapid and effective way. [slug] => 5-questions-from-the-booth-nelipak-healthcare-packaging [body] => The editorial team members of Medical Product Outsourcing and Orthopedic Design & Technology reached out to representatives at several companies exhibiting at Medica/Compamed this year in case you are unable to see them at the event or are not headed to Germany this year. Hopefully, the following questions we served up to Sean Egan, director of global marketing at Nelipak Healthcare Packaging, will offer you some additional insight to determine if the company is a potential services partner for you.
 
MPO: What technology or service are you emphasizing at Medica this year?
Sean Egan: We will be highlighting our digital sketching techniques with designers at the booth demonstrating how the process quickly captures customer input in the design process.
 
MPO: What’s the most common challenge customers inquire about and how do you address it?
Egan: Cost is an ongoing challenge as OEMs react to downward pressure from healthcare providers. While reducing material thickness in the package seems the obvious choice, this is not always the best option given the potential to introduce risk to the protective properties of the package around the product. Better design and incorporating features that make the package part of the procedure go towards reducing total cost of ownership of the tray. The second increasingly common challenge is reduction of material waste, as companies become more aware of playing their part in the circular economy to recycle more hospital healthcare plastics.
 
MPO: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Egan: Work with a partner who understands the industry, materials, regulations, and customer needs with the ability to bring value add to projects in terms of technical know-how and manufacturing reach.
 
It is particularly important to ensure manufacturing partners have the scale and footprint to maintain operations across more than one site. In today’s global operations, OEMs cannot afford to have lines down because a critical operation is dependent on a sole trader operations—this may seem obvious, but many companies have found themselves in this position.
 
MPO: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Egan: Technical expertise and range of equipment coupled with finishing services that provide value add for packaging solutions uniquely position Nelipak to meet customer needs, allowing them to concentrate on their core competencies of device design. Our three design centers and seven manufacturing sites across the Americas and Europe mean we are close to our customers’ facilities with the ability to develop projects within their time zone and reduce their shipping and warehousing needs.
 
MPO: In what ways is your company able to aid in getting a product (project) to market faster?
Egan: Nelipak’s approach to digital sketching kicks off projects faster by providing concept drawings in a couple of days—sometimes even hours—depending on the nature of the project. This allows packaging engineers to share ideas with non-technical people such as surgeons/marketeers who do not read technical drawings. Use of 3D rapid printed concept prototype molds allow for sample shots of small trays/blisters in specified materials, while the technology enables sampling of novel hold features before committing to full tool sets. Simulation provides analysis of material flow and product integrity testing to predict packaging performance before spending time and money on production tools.
 
Nelipak Healthcare Packaging is located at Medica/Compamed in Hall 8B, Booth/Stand J17. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-12 01:00:09 [updated_at] => 2018-11-11 04:53:23 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302033","302063","302050","302025","302036","302048","302068","302037","24946","282671","28830","289738","293035","264716"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306018 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Bally Ribbon Mills","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181039 [primary_image_old] => [slider_image_id] => 181039 [banner_image] => 0 [title] => Bally Ribbon Mills Receives ISO 13485:2016 Certification [short_title] => [summary] => Recertification reflects commitment to supplying highest quality medical products. [slug] => bally-ribbon-mills-receives-iso-134852016-certification [body] => Bally Ribbon Mills (BRM), a company involved in the design, development, and manufacture of highly specialized engineered woven fabrics, announces the company has received ISO 13485:2016 certification. ISO 13485 is the rigorous international standard that governs the design and manufacture of medical devices. BRM passed a surveillance audit with zero non-conformances.
 
For over 50 years, BRM has been supplying the highest quality medical products to its customers. BRM meets the ISO 13485 standards for medical devices by focusing on risk management and design control during product development and by manufacturing its products in a controlled work environment. In addition, BRM follows specific requirements for inspection and traceability for implantable devices as well as for verification of the effectiveness of corrective and preventive actions.
 
BRM’s facility includes advanced weaving systems, yarn preparation, and inspection areas for the production of fabric to the most stringent requirements. Environmental sampling, data collection, storage, and alarms ensure complete environmental monitoring and redundancies.
 
Quality efforts also include an emphasis on continuous improvement and defect prevention. Tools include but are not limited to Management and Feasibility Reviews, AS9102 First Articles, FMEA’s, Control Plans, IQ-OQ-PQ’s, Process/Product Validation and Lean/Six Sigma best practices.
 
For more information, visit https://www.ballyribbon.com/medical-textiles. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-17 14:45:00 [updated_at] => 2019-01-17 14:50:21 [last_updated_author] => 195666 [uploaded_by] => 195666 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305426","290459","293302","300633","288913","297040","30673","289768","299791","303213","305604","293267","301700","305414","294811"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306449 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2613 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181499 [primary_image_old] => [slider_image_id] => 181499 [banner_image] => 0 [title] => High Pressure Braided Tubing [short_title] => [summary] => The highest quality high pressure braided tubing for vascular balloon inflation, contrast injection and vacuum procedures. [slug] => high-pressure-braided-tubing [body] =>
Test And Analytical Capabilities
 
• Superior pressure decay properties
 
• Nitrogen pressure testing at 35 atm
 
• Burst pressure exceeding 1800 PSI
 
• Constant working pressure of 1200 PSI
 
• Impulse burst test
 
• Water leak decay
 
• Vacuum leak decay
 
• Negative pressure test


HPBT Assemblies Via UV & Solvent Bonding
 
• Suction connector
 
• Fixed male & female luer locks
 
• Male rotating union
 
• Additional components available upon request


Medical Device Applications
 
• Contrast media injection
 
• Inflation tubing
 
• Vacuum procedures
 
• Bone cement injection
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