Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
St. Jude Medical, Inc., St. Paul, MN, a global medical device company and a leader in the development of therapies to treat chronic pain, announced FDA approval of its Medical Axium™ Neurostimulator System for dorsal root ganglion stimulation. The company also received FDA approval of approval of the first-to-market MultiPoint™ Pacing technology featured on the Quadra Assura MP™ cardiac resynchronization therapy defibrillator, the Quadra Allure MP™ CRT-pacemaker and two new quadripolar Quartet™ LV leads.
Medtronic plc, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, announced FDA approval of its Deep Brain Stimulation Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication.
Wenzel Spine, Inc., Austin, TX, a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, has received FDA clearance to market its VariLift®-LX as an interbody fusion device for stand-alone use in the lumbar spine.
US Medical Innovations, LLC, Takoma Park, MD, a biomedical device specification manufacturer and subsidiary of US Patent Innovations, LLC, announces that the People’s Republic of China Patent Office has issued a Notification of Granting a Patent Right as well as a Notification of Completion of Formalities for Patent Register for the Canady Hybrid Plasma™ technology. This follows a similar patent recognition by Japan.
Chemence Medical, Inc., Alpharetta, GA, a manufacturer and distributor of adhesive-based medical devices, has received FDA clearance to market and sell Exofin®, a new topical skin adhesive for wound closure.
Masimo, Irvine, CA, a global leader in innovative noninvasive monitoring technologies, has received FDA 510(k) clearance for noninvasive blood pressure and temperature measurements for its Root® patient monitoring and connectivity platform.
Z-Medica, LLC, Wallingford, CT, a developer and marketer of hemostatic devices, has received an expanded CE Mark for its QuikClot® products in the European Union.
ScandiDos, Uppsala, Sweden, a worldwide leader in the development of advanced dosimetry, announced that the company has received FDA 510(k) clearance for its DeltaDiscoverTM, the first device that independently verifies the radiation dose delivered to a patient during radiation treatment.
ReCor Medical, Inc., Palo Alto, CA, which is developing a proprietary ultrasound system for renal denervation, has received an an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device to treat high blood pressure.
APN Health, Milwaukee, WI, has won FDA clearance for Navik 3D, a cardiac mapping system focused on minimizing the cost and complexity of electrophysiology procedures.
Leadership News
Dr. Robert Califf was confirmed by the US Senate as commissioner of the U.S. Food and Drug Administration. He will follow Margaret Hamburg, who stepped down last March, as the new chief.
Zeus Industrial Products, Inc., Orangeburg, SC, which focuses on the development and precision extrusion of advanced polymeric materials, announced that John Winarchick, President of Zeus, has been given the additional title of Chief Executive Officer. This change follows the recent retirement of its former CEO, John Worley, who served the company for 40 years.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, has announced the addition of several new employees across the organization. At Mack headquarters in Arlington, Natasha Aggarwal has joined the company as a program manager, Dennis Becker as a manufacturing engineer, Brittanie Bradley as program coordinator, Rachel Ivey as a program coordinator, and Jim Varney as a quality engineer. Brian Earley has joined Mack’s Southern Division as a business development manager based in New Smyrna Beach, FL; Joshua Grossett accepted the position of tooling engineer with Mack’s Southern Division at the company’s Inman, SC, facility; and Jared Barilovits was hired as a manufacturing engineer at the Inman plant. Joseph Paul joined Synectic Medical Product Development, a Mack Molding company based in Milford, CT, focused on engineering design and development, as a senior design engineer. Mack’s Southern Division recently appointed Aaron Prevette to the position of quality engineer at the company’s Statesville, NC, facility.
Advanced Medical Technology Association (AdvaMed) announced that Scott Whitaker will be its next President and Chief Executive Officer effective April 4. Whitaker, is currently the COO of the Biotechnology Innovation Organization.
Logic PD, Minneapolis, MN, a complete product lifecycle solutions company for the digital world, announced that Lisa Walker was promoted to Chief Operating Officer from the position of Vice President of Product Support Services.
Corindus Vascular Robotics, Inc., Waltham, MA, a global technology leader in robotic-assisted percutaneous coronary interventions, announced that Mark Toland has been appointed Chief Executive Officer and member of the Board of Directors, and Campbell Rogers, MD, has been appointed to its Board of Directors.
J-Pac Medical, Somersworth, NH, which makes implantable textiles and offers packaging and manufacturing services to the medical device industry, has named Michael Dolge as its new Chief Financial Officer and and Phil Littlefield as Vice President of Operations.
Dymax Corporation, Torrington, CT, which develops innovative oligomer, adhesive, coating, dispensing, and light-curing systems, announced the appointment of David Shaskey as a Territory Sales Manager for the Minneapolis region.
Boston Scientific Corp., Marlborough, MA, a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties,announced its Chief Executive Officer Michael Mahoney will serve as Chairman of the Board when company co-founder Pete Nicholas retires from the post in May.
NewAge® Industries, Southampton, PA, which manufactures plastic and rubber tubing, single-use process manifolds and systems, and other molded components, announced the promotion of Stephen McDevitt to Inside Sales Manager.
Expansions/Spinoffs/New Services/Moves
Sil-Pro LLC, Delano, MN, a contract manufacturer specializing in the design and development, manufacturing, assembly, and packaging of silicone and thermoplastic devices, components, and machined parts, has announced an $11 million expansion, which will add 57,000 square feet to their existing building. The company expects to create 104 new jobs within three years.
Technimark, Asheboro, NC, a global manufacturer of custom rigid plastic packaging and components, announced the launch of its new medical division, Technimark Healthcare, which follows Technimark’s recent acquisition of Ci Medical Technologies leveraging its decades of experience in product development, scientific molding, contract manufacturing, assembly, packaging and logistics.
Biotronik, Berlin, Germany, a global leader in cardio- and endovascular medical technology, is setting up its first Asia-Pacific manufacturing facility in Singapore where it expects to hire more than 200 skilled staff. The new plant, which will make components for stents, and cardiac rhythm management devices such as pacemakers, defibrillators and heart failure devices, will begin operations in the second half of this year.
Resonetics, Nashua, NH, a leader in laser micro manufacturing solutions for the medical device and diagnostic industry, plans to open a new production facility in the Coyol Free Zone Business Park in Alajuela, Costa Rica, the company announced. Its new 18,000-square-foot plant will feature a large Class 8 cleanroom, state-of-the-art, ultrafast laser systems and 24/6 operations.
Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery and medical device markets, announced the completion of its Metal Injection Molding facility expansion. The now greater than 50,000 sq. ft. facility is located on the company’s Menomonie, Wi, medical campus. This is the second expansion of this site in the past three years to support continued growth of medical and specialty commercial business segments.
GW Plastics, Bethel, VT, a leader in precision injection molding and contract manufacturing to the healthcare market, announced the completion of a major expansion of its state-of-the-art Dongguan, China, facilities. The company has more than doubled the size of its plant, and the new 125,000 square foot facility will permit the company to streamline its tooling, molding, and medical device assembly operations. GW Plastics has also broken ground on an expansion of its Royalton, VT, facilities. The 21,000 square foot expansion, scalable to 50,000 square feet, will accommodate additional growth of its thermoplastic and LSR injection molding and medical device contract assembly business.
Covestro AG, Leverkusen, Germany, formerly Bayer MaterialScience and one of the world’s largest polymer companies, is expanding production capacity for polycarbonate films at its Dormagen, Germany, site. The company is constructing a new coextrusion plant for high-quality, multilayer flat films and is scheduled to come on stream in 2017.
Owl Manor Medical LLC, New Orleans, LA, which is dedicated to joint preservation and advanced wound care treatment announced plans to establish operations in Warsaw, IN, creating up to 33 new jobs by 2019.
Mergers/Acquisitions/Collaborations/Licensing
Stryker Corporation, Kalamazoo, MI, one of the world's leading medical technology companies offering a range of products and services in orthopaedics, medical and surgical, and neurotechnology and spine technology, agreed to acquire 100% of the stock of Physio-Control International, Inc., Redmond, WA, which develops, manufactures, and markets monitors/defibrillators, automated external defibrillators, and CPR-assist devices, along with data management and support services.
Thermo Fisher Scientific, Tewksbury, MA, a world leader in serving science, has acquired INEL Inc., Artenay, France, a provider of real-time X-ray diffraction systems. The business will be integrated into Thermo Fisher’s Analytical Instruments Segment.
Lee AntiMicrobial Solutions, Armonk, NY, which is working to commercialize antimicrobial solutions, has partnered with Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, in commercializing Lee’s innovative Dilute Hydrogen Peroxide (DHP) technology, which uses small amounts of humidity and oxygen from the surrounding air to produce hydrogen peroxide, which can be used continuously in occupied spaces to kill viruses, bacteria, and mold in the air and on surfaces. Mack is also working with has announced it is working with LabMinds, Oxford, UK, and Boston, MA, a laboratory equipment developer creating a smart, adaptable, and fully automated liquid solution production system. Mack providing a significant portion of the components, as well as managing final assembly and test of the complete product.
Proven Process Medical Devices Inc., Mansfield, MA, a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, has been selected as the US product development partner to further develop and manufacture a novel medical device from Innoblative Designs, Inc., Evanston, IL, a medical device company developing products to improve how to treat surgical margins post excision.
FormFactor Inc., Livermore, CA, which provides wafer test technologies and expertise, has agreed to acquire Cascade Microtech Inc., Beaverton, OR, which provides equipment enabling precision contact, electrical measurement and test of wafers, ICs, IC packages, circuit boards and modules as well as MEMS, 3D TSV and LED devices.
SAKI America, Fremont, CA, an innovator in the field of automated optical inspection equipment, has selected Creyr Innovation, LLC, East Greenwich, RI, a supplier representative company, as its representative in Rhode Island, Connecticut, Massachusetts, Vermont, New Hampshire, Maine, and New York (except metropolitan NY and Long Island).
Enable Injections LLC, Sharonville, OH, which develops and makes wearable devices that allow a user to administer injectable drugs, has entered into a product development and manufacturing partnership with Flextronics International Ltd., San Jose, CA, leader in high volume manufacturing of body-worn injection systems. The companies will collaborate on the design, development, and production of customized wearable injector systems.
Exact Metrology, Inc., Brookfield, WI, a comprehensive metrology services provider, is now representing the ProCon line of x-ray inspection equipment for industrial and commercial concerns in North America.
International TechneGroup Limited (ITI), Cambridge, UK, whose mission is to help manufacturers drive innovation and time to market by applying computer-aided product development to engineering problems, announced a formal alliance between ITI and DIGITREAD, Sandvika, Norway, a solution provider of PLM technologies and a value-added reseller of ITI CAD solutions for PLM migration projects.
Icon Labs, West Des Moines, IA, a leading provider of embedded networking and security technology, and Micriumn Inc., Weston, FL,a premier real time operating systems provider for embedded systems, announced the integration of Icon Labs’ Floodgate Security Framework with Micrium’s µC/OS-III® RTOS. The integrated solution creates a secure platform for IoT devices and extends the Internet of Secure Things initiative into systems and solutions with limited resources.
SpectraScience, San Diego, CA, which designs, develops, manufactures, and markets spectrophotometry systems designed to determine whether tissue is pre-cancerous or cancerous without removing tissue samples, has acquired the assets of Oncoscope, Durham, NC, an optical imaging system company that developed a proprietary system designed for the minimally invasive detection of Barrett’s Esophagus.
IPC — Association Connecting Electronics Industries, Bannockburn, IL,has become a partner of NextFlex, Mountain View, CA, the flexible hybrid electronics manufacturing institute. As part of the National Network for Manufacturing Innovation, this new public-private partnership aims to establish America as the global leader in the flexible hybrid electronics manufacturing space.
Miscellaneous
Aries Electronics, Bristol, PA, a manufacturer of programmed and custom interconnection products, announced that Enterprise Technology, Inc., Harvard, MA, an Aries representative servicing the New England territory, has been named Aries’ 2015 Representative of the Year.
MedAccred, Warrendale, PA, an industry managed supply chain oversight program that assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices, announced that MTD Micro Molding, Charlton, MA, became the first micro injection molding company to pilot the new MedAccred Plastics Injection Molding audit criteria, BMP Medical, Gardner, MA, became the first injection molding company to complete a pilot audit against the new audit criteria, and Global Technologies, Spring Lake, MI, became the first company in the world to receive MedAccred Cable & Wire Harnesses accreditation.
Epoxy Technology Inc., Billerica, MA, a leading manufacturer of high performance specialty epoxy, UV, and Hybrid adhesives founded in 1966, is celebrating 50 years of adhesive innovation to meet the critical performance standards of high-tech industries worldwide.
Bluestar Silicones, East Brunswick, NJ, announced that its Silbione® BiomedicalLiquid Silicone Rubber product line for long-term implant applications is produced and packaged in its newly certified and accredited ISO 8 and ISO 7 clean rooms in its 226,000 sq. ft. facility in York, SC.
The Society of Plastics Engineers (SPE) ANTEC® 2016, the world’s largest plastics technical conference, will be held May 23-25 in Indianapolis, IN. In addition to hundreds of original, peer-reviewed presentations, SPE will hold its global parts competition and a scavenger hunt with a plastics twist on the exhibit floor. For more information, visit www.antec.ws .
Minnesota Rubber and Plastics, Minneapolis, MN, a global leader in the formulation of high performance rubber and plastic parts, has been awarded the 2015 Best Quality Award from Xiamen Runner Industrial Corporation of China, a leading global manufacturer in multiple industries. The annual award is presented to suppliers meeting the highest quality standards in a year and best among Xiamen’s thousands of suppliers.
TOPAS Advanced Polymers, Frankfurt, Germany, Florence, KY, and Tokyo, Japan, is celebrating its 10th anniversary under current ownership as the leading global supplier of cyclic olefin copolymer (COC) under the TOPAS® brand. Daicel Corporation and Polyplastics Co., Ltd., two leading Japan-based chemicals and plastics firms, acquired the TOPAS Advanced Polymers business in 2006.
