Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Covidien plc, Dublin, Ireland, announced it has received FDA approval of its Apollo™ Onyx™ delivery micro catheter, the first detachable tip micro catheter available in the US, designed to mitigate the technical challenges of catheter retrieval during embolizations of brain arteriovenous malformations.
Olympus, Center Valley, PA, a global technology leader in innovative diagnostic and therapeutic solutions for medical and surgical procedures, announced the commercial availability of its 510(k) cleared, next-generation GIF-1TH190 gastrointestinal videoscope for endoscopy or endoscopic surgery use within the upper digestive tract.
Cothera LLC, Plano, TX, a global medical device manufacturer, has received ISO 13485:2012 certification. This independent certification validates Cothera’s long-standing commitment to quality, and affirms that Cothera’s quality management system provides a solid foundation for its medical device initiatives.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, and CardioMEMS, Atlanta, GA, announced FDA approval of the CardioMEMS™ HF System. The CardioMEMS HF System is the first and only FDA-approved heart failure (HF) monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage heart failure.
Advanced Cooling Therapy, Chicago, IL, a medical device manufacturer, has received a license for commercial sale of its first product, the Esophageal Cooling Device, from Health Canada. The device received the CE Mark in April and is pending regulatory clearance in the US.
Toshiba America Medical Systems, Tustin, CA, has launched the AquilionTM ONE Family, the industry’s only scalable premium CT solution, which provides the ability to upgrade systems without replacing hardware.
Breas Medical, Molnlycke, Sweden, has released Z1 cpap devices in Europe and other markets outside the USA . The company says that it is lighter, smaller, quieter and more integrated than other cpap machines .
GE Healthcare, Milwaukee, WI, announced FDA approval and the US launch of its new breast imaging technology, the Invenia™ ABUS, which was proven to help clinicians find 35.7% more cancers in women with dense breasts than mammograms alone.
Dexcom, Inc., San Diego, CA, a leader in continuous glucose monitoring (CGM), announced that it has received FDA approval for its Dexcom G4® PLATINUM Professional CGM, which it says is the first and only real-time professional CGM system.
QT Vascular Ltd., Singapore, announced that its wholly owned US subsidiary, TriReme Medical LLC, Pleasanton, CA, received FDA of 510(K) clearance to market its Chocolate® PTCA Balloon Catheter in the US, for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Leadership News
Biosensors International Group, Ltd., Singapore, a developer, manufacturer, and marketer of innovative medical devices, announced that Jose "Pepe" Calle Gordo has been appointed the company's new Chief Executive Officer, as of November 1, 2014. Jack Wang will take on a new role of Chief Technology Officer. Yoh-Chie Lu, Biosensors' Executive Chairman, will serve as interim CEO during this transitional period.
Intelligrated®, Cincinnati, OH, a leading automated material handling solutions provider, announced the appointment of Tommy Vacarella as sales engineer for its southern regional operations, based in Alpharetta, GA.
J-Pac Medical, Somersworth, NH, an outsourcing partner providing contract manufacturing solutions for the medical device and diagnostic industries, announced that Mark Simmons has joined the company as Director of Quality and Regulatory Compliance.
Orchid Design, Shelton, CT, and Memphis, TN, a division of Orchid Orthopedic Solutions, announced enhancements to its Quality Assurance and Regulatory Affairs Consulting team. Kellen Hills has joined the Memphis location as a Senior QA/RA Consultant. Emily Magazzi, QA/RA Consultant, recently achieved Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.
SAS Automation, Xenia, OH, a global leader in robotic End-of-Arm tooling and automation technology, announced that Bob Lord has joined as Sales and Marketing Manager.
Xeridiem, Tucson, AZ, which is focused on the design, development, and manufacture of single-use medical devices used in gastroenterology, cardiology, and urology, has appointed Shubroto Chattopadhyay as Senior Business Development and Marketing Director.
Tianma NLT America, Santa Clara, CA, has announced the appointment of Lesa Qu as Chairwoman and President, effective June 1. She replaces Dr. Shigehiko Sato as President of Tianma NLT America, who will continue to serve as a Senior Advisor to the company. She is also Vice General Manager of Tianma Micro-Electronics Co., Ltd., Director of Shanghai Tianma Microelectronics Co., Ltd., Chairwoman and General Manager of Tianma Micro-Electronics Korea Co., Ltd., and Chairwoman of Tianma Micro-Electronics USA.
IPC – Association Connecting Electronics Industries announced that Keenan Loubser has joined the IPC staff as Senior Director of Certification Programs. Kenneth Schramko has joined IPC’s Washington, DC-based government relations team as Director of Government Relations.
MicroCare Corp., New Britain, CT, a global manufacturer of precision cleaning, coating, and lubrication products, announced the addition of Agustin Mireles in El Paso, TX, as regional sales manager to exclusively serve the rapidly growing markets in Mexico.
The Arthur G. Russell Company, Inc., Bristol, CT, a leading provider of automatic assembly solutions, announced the appointment of James Magoon of Magoon Technology Group, LLC, as an authorized sales representative.
Expansions/Moves
Value Plastics, Inc., a Nordson Company, Fort Collins, CO, broke ground on a new state-of-the-art manufacturing facility in Loveland, CO, to meet growing demand for its engineered, single-use plastic-molded fluid management components.
The Advanced Medical Technology Association (AdvaMed) announced that Chinese authorities have approved its application to open a representative office in Shanghai, where many AdvaMed members have their China headquarters. AdvaMed also established a China Council, consisting of member companies’ senior representatives in the country.
Polyzen Inc., Apex, NC, a leader in custom, thin wall components for medical devices, has recently expanded its cleanroom manufacturing operations to include state-of-the-art film extrusion in a Class 10,000 environment, which will support prototype development, scale-up, and manufacturing of film for use in regulated medical devices.
Barcoding, Inc., Baltimore, MD, a a national systems integrator, specializing in the development, deployment, and management of supply chain and mobility systems, has opened an office in San Diego, CA, headed by Micheal Ghandy, director of sales.
Nelson Laboratories, Salt Lake City, UT, announced the expansion of its services with the addition of a dedicated Technical Consulting Services group for MedTech companies, which encompasses product development, facility and process validation, product performance testing, and regulatory support to help clients deliver medical devices to market that are safe and effective.
MRPC, Butler, WI, a single-source provider of medical device components and assemblies, celebrates two major achievements this month: recognition by the Milwaukee Journal Sentinel as a 2014 Top Workplace in Southeastern Wisconsin, and the grand opening of its 15,000-square-foot facility expansion to its Milwaukee plant.
Mergers/Acquisitions/Collaborations/Licensing
Volcano, San Diego CA, an imaging technology company, has signed an agreement to acquire AtheroMed and its Phoenix atherectomy catheter system. Manufacturing will begin at AtheroMed's Menlo Park, CA, facility before moving to Volcano's Costa Rica facility late next year.
EOS, Novi, MI, the technology and market leader for design-driven industrial 3D printing, announces the integration of Advanced Laser Materials, Temple, TX, and Integra, Round Rock, TX, a strategic development to strengthen their service and application offerings in North America.
Welch Allyn, Inc., Skaneateles Falls, NY, a leading medical diagnostic device company, announced the acquisition of certain assets of PediaVision Holdings, LLC, Lake Mary, FL. PediaVision is a leading developer of vision technology.
Shanghai Moons’ Electric Co., Ltd., Shanghai, China, announced that it has acquired Applied Motion Products, Inc., Watsonville, CA, which specializes in providing advanced stepper and servo motor drives to a broad range of industrial and OEM customers.
Lumalier Corporation, Memphis, TN, announced the sale of the company's in-duct and upper-air UV product lines to Evergreen UV LLC, Memphis, TN.
Kelpac Medical, Pleasant Prairie, WI, a division of PPC Industries, has acquired a major capital position in Apollo Medical Extrusion, Sandy, UT. Kelpac Medical, a world leader in manufacturing and supplying custom thermoplastic medical tubing and medical packaging, has seven locations worldwide. Apollo Medical Extrusion is a premier extruder of micro-bore tubing, catheter tubing, and multi-lumen tubing of complex geometries and tight tolerances.
Miscellaneous
Mouser Electronics, Inc., Mansfield, TX, has just launched its new Wearables Technology site, sponsored by STMicroelectronics. For information, visit http://www.mouser.com/stmicro-wearables/?cm_mmc=PressRelease-PR-_-STmicro-_-WearablesSite-_-2014-06-10 .
Esaote, London, UK, one of the world’s leading medical imaging manufacturers, has launched a new global website at www.esaote.com . Optimized for a fast user experience on any device from desktop to smartphone, the site quickly leads the browser to relevant imaging content.
The Society of Plastics Engineers Thermoforming Division has announced a call for entries in its annual Parts Competition, showcasing the latest advances in thermoforming design and application. Full information on the competition is available at www.thermoformingdivision.com The submission deadline is August 15.
Newcomb Spring of Canada Ltd., Mississauga, Ontario, announced its 50th anniversary in business serving customers around the world with high quality precision springs, wire forms, and metal stampings. It is one of the region’s leading precision custom component suppliers.
Classic Industries, Latrobe, PA, a multifaceted single-source manufacturer of injection-molded components used in medical devices and pharmaceutical products, is now known as Ci Medical Technologies. The name change reflects the company’s ability to provide design, manufacturing, assembly, packaging and logistics services worldwide.
Colder Products Company, St. Paul, MN, the leading provider of quick disconnect couplings, fittings and connectors, has changed its name to CPC. Its new website is www.cpcworldwide.com
SoldierSocks, Stamford, CT, a non-profit foundation focused on helping veterans, announced that it is donating an Ekso Bionics exoskeleton to the VA Palo Alto Health Care System to launch a new era of rehabilitation. The Ekso GT™ was donated in full by wireless visionary Steven Sherman, as part of his goal to help one million people, including injured veterans, walk again.
FloMet LLC, DeLand, FL, an ARCMIM Company, has earned the Grand Prize in the Medical/Dental Category of the Powder Metallurgy Design Excellence Awards Competition, sponsored by the Metal Powder Industries Federation, for two 5 millimeter tines—one fixed, one moving—that go into a thermal tissue fusion and dissection system made by its customer ConMed, Utica, NY. The system utilizes direct thermal energy and pressure to effectively seal, transect, dissect, and coagulate tissue. Smith Metal Products, Center City, MN, won an Award of Distinction in the Medical/Dental Category for a metal injection molded (MIM) 17-4 PH stainless steel shaft assembly used in a novel surgical instrument for passing suture through difficult-to-reach tissue. Indo-US MIM Tec Pvt. Ltd., Bangalore, India,also won an Award of Distinction in the Medical/Dental Category for a sound tube used in a hearing aid made by its customer Phonak, Germany.
