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Medical device news, medical equipment design and medical contract manufacturing.

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    Lexington Biosciences (Vancouver, British Columbia) said today that it has brought on reimbursement experts as it seeks FDA clearance for its HeartSentry device. The strategic business relationship with a San Francisco arm of Chicago-based Navigant Consulting, is meant to help Lexington(CSE: LNB) (OTCQB: LXGTF) better work with relevant authorities to develop a coverage policy to support the commercial

    The post Lexington Biosciences moves forward with its affordable heart diagnostic device appeared first on Medical Design and Outsourcing.


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    Solvay has launched its new Zeniva ZA-600 CF30 polyetheretherketone (PEEK) designed for use in implantable device applications. Zeniva ZA-600 CF30 PEEK is a 30% carbon fiber-reinforced, radiolucent polymer that offers modulus that is similar to cortical bone. The polymer helps implants minimize bone density reduction while maintaining normal stress on surrounding bone tissues. The polymer

    The post Solvay releases new PEEK polymer for implantable devices appeared first on Medical Design and Outsourcing.


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    Sterifre Medical, a company that has developed a desktop sterilization device that only uses room temperature plasma, has raised nearly $5 million in its present funding round, according to a recent U.S. Securities and Exchange Commission filing. The company has raised $4,827,500 toward its present $12 million goal, according to a Form D filed with

    The post Sterifre Medical raises nearly $5 million for desktop sterilization device appeared first on Medical Design and Outsourcing.


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    From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press releasethat it has signed its first European distribution deal with Italian company Moss and

    The post Medtech stories we missed this week: Dec. 8, 2017 appeared first on Medical Design and Outsourcing.


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    Asahi Kasei Group company Zoll Medical said it inked an exclusive strategic multi-year deal with advanced manufacturing company Myant to develop technologies for future versions of Zoll’s LifeVest wearable defibrillator. The company’s LifeVest is designed to be worn by patients at risk of sudden cardiac death to monitor the heart continuously for abnormal heart arrhythmias

    The post Zoll Medical, Myant ink next-gen LifeVest dev deal appeared first on Medical Design and Outsourcing.


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    The same Kevlar material that is used to make bulletproof vests, jackets and gloves now has the potential to make artificial cartilage that could be implanted in the body. Kevlartilage – a material developed at the University of Michigan and Jiangnan University – can withstand just as much force as the cartilage in the human

    The post This artificial cartilage is made using material from bulletproof vests appeared first on Medical Design and Outsourcing.


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    Among the most successful medical device companies this year, there were two themes: innovation and breadth of services. That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world. What does innovation mean? Think Align Technologies (Nasdaq:ALGN) and how it brought 3D

    The post How do some medical device companies perform better than others? appeared first on Medical Design and Outsourcing.


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    CerMet – an advanced ceramic and metal technology system – creates the potential for implantable devices with thousands of electrical channels. Think new options for treating blindness and neurological conditions. Only a few years old, Heraeus’ CerMet is upping the game when it comes to sophisticated implantable electronic devices. “Medical implants manufactured using the Heraeus CerMet

    The post This innovation could make medical devices even more amazing appeared first on Medical Design and Outsourcing.


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    GI Plastek, Precision Southeast and Plastics Solutions have merged to form PSI Molded Plastics. The three companies are owned by Gladstone Investment. The merger allows for PSI Molded Plastics to provide its customers injection molded component requirements in one place, including large to small parts from low to high volumes. The company will also provide

    The post GI Plastek, Precision Southeast, Plastics Solutions merge to form PSI Molded Plastics appeared first on Medical Design and Outsourcing.


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    When it comes to dip molding products with emulsions of liquid rubber, it is necessary to complete a series of process steps to assure proper formation, vulcanization and finish treatment to meet the customer’s needs in the final application. Mark Agee, Kent Elastomer Products Dip molding can enable the creation of durable medical device parts in

    The post Dip molding medical device products: What you need to know appeared first on Medical Design and Outsourcing.


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    Omnia Medical has received FDA 510(k) clearance for a vertebral body replacement (VBR) system for use in the thoracolumbar spine to replace collapsed, damaged or unstable vertebral body. The VBR system is manufactured from PEEK-Optima HA enhanced polymer through a collaboration with Jalex Medical on product development and regulatory activities and Invibio Biomaterial Solutions who

    The post Omnia Medical receives FDA 510(k) clearance for vertebral body replacement system appeared first on Medical Design and Outsourcing.


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    Innovation is important in medtech and many other industries. But what does it really mean – and can it be done with speed? That was the question that a panel of experts grappled with today at DeviceTalks West in Orange County, Calif. It turns out that there is more than meets the eye when it

    The post How to think outside the box with medtech innovation appeared first on Medical Design and Outsourcing.


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    A team of biomedical engineers have developed a fully functioning artificial human heart muscle that can be used as a patch to repair dead heart muscle. Duke University biomedical engineers developed the patch to be used in human patients who have previously suffered a heart attack. “Right now, virtually all existing therapies are aimed at

    The post These artificial heart muscle patches can repair dead heart muscles appeared first on Medical Design and Outsourcing.


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    Cadence has expanded its laser processing technologies with a new CL900 Cincinnati laser cutting machine. The new 4,000W fiber laser cutter adds to Cadence’s modified tube cutting lasers and completely custom flat sheet cutting lasers, Cadence announced yesterday. It also has the ability to cut 1,000 in. per minute (IPM) with a positioning accuracy of +/-0.001

    The post Cadence expands laser processing capabilities appeared first on Medical Design and Outsourcing.


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    Medline recently completed its previously announced acquisition of Centurion Medical Products – boosting offerings around the Medline Erase BSI line access and dressing change bundles. Financial terms of the deal were not disclosed. Medline’s Erase BSI is meant to standardize best practices around central lines post-insertion, reducing cases of bloodstream infections. On top of its minor procedure trays, Centurion makes vascular insertion

    The post Medline acquires Centurion Medical Products appeared first on Medical Design and Outsourcing.


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    Researchers are one step closer to creating a prosthetic hand that allows users to have full control over each finger, according to a new report from Georgia Tech. Researchers at the university say they have created an ultrasonic sensor which allows amputees to control individual fingers on a prosthetic hand, with enough sensitivity to play

    The post Researchers create ultrasound-sensor powered prosthetic hand with individual digit control appeared first on Medical Design and Outsourcing.


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    By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this

    The post New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies appeared first on Medical Design and Outsourcing.


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    Summit Medical’s InstruSafe and TransEnterix’s Senhance Surgical Robotic System  have forged a partnership to launch two new surgical instrument trays for use with the robotic platform. The two new trays will include an instrument tray an an endoscopic adapter tray, both of which have been validated for the Senhance instrumentation. “We are excited to expand our product offering

    The post InstruSafe and Senhance Surgical Robotic System partner to launch instrument trays appeared first on Medical Design and Outsourcing.


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    Medical device and OEM company Millar said today it is selling its lifesciences telemetry product division to New Zealand-based Kaha Sciences. Houston-based Millar said the divestiture comes as the company looks to focus its efforts on the clinical and OEM business segments in a strategy that emerged earlier this year. Kaha Sciences has picked up a handful

    The post Millar offloads telemetry product line to Kaha Sciences appeared first on Medical Design and Outsourcing.


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    A group of manufacturing services companies have created a collaborative called the Medical Device Development Collaborative (MD2C) to help with access to a full range of product development capabilities for concept to market solutions. The collaboration is based in the Medical Alley region and aims to help small to mid-size OEMs by offering experience and

    The post Manufacturing companies form collaborative for advancing product development capabilities appeared first on Medical Design and Outsourcing.


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