Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approvals, Standards, and Launches

Noxilizer, Inc., Baltimore, MD, which is advancing a nitrogen dioxide-based sterilization process for pharmaceutical, biotech, and medical device manufacturers, has received FDA 510(k) clearance for a medical device terminally sterilized using the company’s sterilization process.

Integro Technologies Corp., Salisbury, NC, a leading vision integrator, has been named a Certified Integration Partner for MVTec Software GmbH, Munich, Germany, a leading, international manufacturer of software for machine vision used in all demanding areas of imaging: semiconductor industry, web inspection, quality control, and inspection applications. MVTech has only six partners in North America.

Bodycote, Macclesfield, UK, the world's largest provider of thermal processing services, has become the first company in Europe to receive a critical process accreditation from MedAccred, Warrendale, PA, and London, UK, an industry managed supply chain oversight program. Bodycote’s Derby, UK, site received accreditation for Heat Treating after successfully completing a demanding audit of the facility’s vacuum heat treating compliance to customer requirements, industry standards, and best practices.

W. L. Gore & Associates, Inc., Flagstaff, AZ, which designs a family of products including vascular grafts, endovascular and interventional devices, surgical meshes, staple line reinforcement materials, and sutures, has received the CE Mark for its GORE® EXCLUDER® Conformable AAA Device, designed to treat abdominal aortic aneurysms in patients with challenging anatomies.

Occlutech, Helsingborg, Sweden, a leading innovator of implants to treat structural heart disease, has received the CE Mark for its Left Atrial Appendix occluder, clearing the way for its use in the European Union.

Additive Orthopaedics, Little Silver, NJ, which specializes in additive manufacturing, announced that its 3D printed titanium digital fusion implant, has received FDA 510(k) clearance.

Micro Interventional Devices, Newtown, PA, a leader in minimally invasive and catheter-based compliant fixation technology, has earned CE Mark approval for its transapical access and closure device Permaseal, a novel transapical access and closure device.

Heart Test Laboratories, Inc., Westlake, TX, has achieved ISO 13485:2003/NS-EN ISO 13485:2012 certification for its quality management systems related to the design and development, manufacturing, distribution, and servicing of active non-invasive electrocardiographic devices.

Leadership News

Lowell, Inc., Minneapolis, MN, a precision machining contract manufacturer, announced that Ed Yaris has joined the company as the new Quality Manager.

Keystone Heart Ltd., Caesarea, Israel, an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiac procedures, announced Chris Richardson will take on the role of the company’s President and CEO.

SunTech Medical, Morrisville, NC, a leading supplier of clinical grade blood pressure monitoring products and technologies, has appointed Sandra Wisniewski as its new CEO.

InspireMD, Inc., Boston, MA, a leader in embolic prevention systems, neurovascular devices, and thrombus management technologies, today announced the immediate appointment of James Barry, PhD, as President and CEO.

Zynex, Lone Tree, CO, a medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, neurodiagnostic equipment, and cardiac and blood volume monitoring, announced the hire of David “Skip” Mogill as Vice President of Operations.

Phillips-Medisize Corporation, Hudson, WI, a global-leader in outsource design, development, and technology-driven manufacturing, announced that William Nee has joined the company as the Chief Human Resources Officer and Vice President, Global Human Resources.

German Machine Tools of America, Ann Arbor, MI, a major supplier of various machine tools, lasers, and parts washers to the North American market, announces the appointment of Dan Thomas as Project Manager.

Expansions/Spinoffs/New Services/Moves

Hexagon Manufacturing Intelligence North America, North Kingstown, RI, announced the launch of its new Integrated Solutions strategic business unit, dedicated to Smart Factory systems for advanced manufacturing. This highly-specialized team will develop automated commercial-off-the-shelf systems by integrating Hexagon’s 3D measurement technologies with sensors, software, and robotics.

CTS Corporation, Elkhart, IN, a leading designer and manufacturer of sensors, actuators, and electronic components to OEMs, announced a restructuring plan to phase out production at its Elkhart, IN, plant by mid-2018 and transition the location into a Research and Development Center supporting the company’s global operations.

Nihon Kohden, Irvine, CA, a leading manufacturer, developer, and distributor of medical electronic equipment, is opening a technical support call center in Allentown, PA.

Resonetics, Nashua, NH, a leader in laser micro manufacturing solutions for life sciences, has added a second Lightspeed ADL™ Application Development Lab in its Dayton, OH, facility to complement the existing lab in Boston. This new 1,100 sq. ft. operation has dedicated systems for laser ablation, cutting, and welding.

Mergers/Acquisitions/Collaborations/Licensing

Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, and medical device markets, has acquired Medicom Innovation Partner, Struer, Denmark, a leading provider of device strategy, product design, and development services with particular focus on personal connected health drug delivery device solutions. Phillips-Medisize was also recently nominated for the 2016 Secretary of Defense Freedom Award. The award is the highest level of employer recognition given by the US government for supporting employees who also serve in the Armed Forces. Only 15 employers nationally receive the award each year.

Zimmer Biomet Holdings, Inc., Warsaw, IN, a global leader in musculoskeletal healthcare, has agreed to acquire LDR Holding Corp., Austin, TX, a global medical device company focused on designing and commercializing surgical technologies to treat patients suffering from spine disorders. LDR will be combined with Zimmer Biomet’s spine and cranio-maxillofacial (CMF) business and will be led by Adam Johnson, president of Zimmer Biomet’s spine, CMF, thoracic, and dental divisions.

NuVasive, Inc., San Diego, CA, a leading medical device company focused on transforming spine surgery, has agreed to acquire Biotronic NeuroNetwork, Ann Arbor, MI, a provider of intraoperative neurophysiological monitoring services.

HTI Technology, Inc., Nashville, TN, a global producer of AC, DC, and Brushless DC motors, gear motors, and motorized assemblies, has acquired Klauber Machine & Gear, Co., Pacific, MO, a producer of AC and DC gear motors.

Medivative Technologies LLC, Indianapolis, IN, a contract manufacturer for the medical device industry, has been sold to Kimball Electronics Group LLC, Jasper, IN, which offers complete product life cycle support for electronic manufacturing assemblies in the medical, industrial, automotive, and public safety industries.

Miscellaneous

Intertek, Chicago, IL, a Total Quality Assurance provider to a range of industries worldwide, announces its new services to help manufacturers of medical electrical equipment verify their products are environmentally conscious. The services are an expansion of Intertek's existing IEC 60601-1 services and consist of an engineering review of product design and development processes in line with the IEC 60601-1-9 standard on environmentally conscious design. The new offering was developed in conjunction with an Intertek white paper  identifying how the IEC standard can be used to promote sustainability claims.

Allied Motion Technologies, Inc., Amherst, NY, a global designer and manufacturer of motion control products, announced the launch of its new website at www.alliedmotion.com  and Engineering Insights blog.

Phillips-Medisize, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, and medical device markets, was nominated for the 2016 Secretary of Defense Freedom Award. The award is the highest level of employer recognition given by the US government for supporting employees who also serve in the Armed Forces. Only 15 employers nationally receive the award each year.

KOA Speer Electronics, Bradford, PA, a leading supplier of passive electronic components, announced that the company has received the 2015 Platinum, Diamond, and Best Quality Awards for Supplier Excellence from TTI, Fort Worth, TX, an authorized, specialty distributor of interconnect, passive, and electromechanical components. This is the sixth consecutive year KOA Speer has received the TTI Diamond and Best Quality awards.

Husky Injection Molding Systems, Bolton, Ontario, Canada, a leading industrial technology provider to the plastics processing community, announced that its medical business has been awarded a prestigious Process Innovation Supplier award from Becton Dickinson, Franklin Lakes, NJ, a leading global medical technology company.

Gardner Denver THOMAS, Sheboygan, WI, marked June 8, 2016 as the 40-year anniversary of the patent issuing for the WOB-L® piston compressor technology. THOMAS invented and originated this technology, which is a new class of pumps in between articulated and diaphragm pump technologies.