Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Molex Incorporated, Lisle, IL, a global manufacturer of electronic solutions, announced that the Molex Dongguan, China, facility is now registered with the U.S. Food and Drug Administration (FDA) as a compliant manufacturer of Class I medical devices.
GE Healthcare, Wauwatosa, WI, has launched its Vscan with Dual Probe pocket-sized ultrasound tool with the first of its kind 2-in-1 probe. It houses two transducers in a single probe, allowing clinicians to see both shallow and deep views of the body without changing probes.
Oxford Performance Materials, Inc., South Windsor, CT, a leading advanced materials and additive manufacturing company, has received FDA 510(k) clearance for its 3D printed OsteoFab® Patient-Specific Facial Device, the first and only FDA cleared 3D printed polymeric implant for facial indications.
Helix Medical, LLC, Baldwin Park, CA,a global manufacturer for the medical device, pharmaceutical, and IVD industries, announced FDA registration for its medical device manufacturing operation in Baldwin Park. The operation’s quality system is in compliance with FDA 21 CFR 820 as well as ISO 13485.
Westmed, Inc., Tucson, AZ, a leader in the design, manufacture, and marketing of medical devices for respiratory therapy and anesthesia, has received FDA 510(k) clearance to market the company's Vibralung® Acoustical Percussor.
Nipro Diagnostics, Inc., Ft. Lauderdale, FL, announced that the FDA has cleared its TRUE METRIX™Self-Monitoring blood glucose system and the TRUE METRIX™PRO Professional Monitoring blood glucose system.
Intuitive Surgical, Inc., Sunnyvale, CA, the global leader in robot-assisted minimally invasive surgery, announced FDA clearance of FireflyFluorescence Imaging for its da Vinci® Xi™ Surgical System.
Hansen Medical, Inc., Mountain View, CA, a global leader in intravascular robotics, has received FDA 510(k) clearance for a modified rail for its Magellan™ Robotic System, which enables the company to begin commercial introduction of the Magellan™ Transport System designed to move the Magellan robotic arm between procedure rooms.
Leadership News
Sussex Wire, Inc., Easton, PA, a manufacturer of miniature, precision, geometrically complex, cold formed components, announced the appointment of Paul Hnat to the role of Global Account Manager.
Trinity Medical Devices Inc., Parsippany, NJ, a medical device company pioneering the field of generic medical devices, announced that Tony Dimun and Robert Coradini have been appointed to the company’s Board of Directors.
Pulse Systems, Inc., Wichita, KS, an industry-leading provider of Electronic Health Record solutions, announced that Michael Morrison has joined the company as its new Chief Technology Officer and Senior Vice President of Product Development.
Calumet Electronics Corporation, Calumet, MI, announced the appointment of PCB industry veteran Mike Kadlec as Vice President of Business Development, to grow markets and build a national sales force.
Newcomb Spring Corp., Decatur, GA, a worldwide supplier of compression springs, extension springs, torsion springs, wire forms, stampings, rings, hooks and battery contact springs, announced that Ron Hubbard, General Manager of Newcomb Spring of Texas, is celebrating 50 years with the company.
Isola Group S.à r.l., Chandler, AZ, a market leader in copper-clad laminates and dielectric prepreg materials used to fabricate advanced multilayer printed circuit boards, announced that Antonio “Tony” Caputo has joined its Analytical Services Lab in Chandler.
Expansions/Moves
GE Healthcare Life Sciences, Pittsburgh, PA, announced that it is planning to open a new 160,000-square-foot headquarters for its US operations in Marlborough, MA, scheduled to open in spring 2015.
Baxter International, Inc., Deerfield, IL, plans to expand its manufacturing facility for production of dialyzers in Opelika, AL.
The Canadian government announced that it will invest $14.9 million in a new Medical Devices Commercialization Centre, stemming from the University of Ottawa Medical Devices Innovation Institute. The Centre will initially be housed at the University of Ottawa Heart Institute.
Mergers/Acquisitions/Collaborations/Licensing
Binder-USA, Camarillo, CA, a global supplier of high-quality circular connectors and cordsets, has formed a strategic partnership with Northwire, Inc., Osceola, WI, which produces custom wire and cable interconnect solutions.
Covidien plc, Dublin, Ireland, a global healthcare products company, acquired Reverse Medical Corporation, Irvine, CA, a vascular disease devicemaker.
Medtronic, Inc., Minneapolis, MN, a global leader in medical technology, announced that it has acquired Sapiens Steering Brain Stimulation (Sapiens SBS), Eindhoven, The Netherlands, a developer of deep brain stimulation technologies. Medtronic also bought Italian company, NGC Medical S.p.A., which manages cardiovascular suites, operating rooms, and intensive care units for hospitals.
Miscellaneous
B. Braun’s OEM Division, Bethlehem, PA, has launched an onlineResource Centerat http://www.bbraunoem.com/resources, to offer engineers and supply chain representatives expertise ranging from medical device design to improving the supplier management process.
Connecticut Spring & Stamping (CSS), Farmington, CT, a manufacturer of precision parts for the medical, aerospace, firearms and defense industries, has launched a “5S” workplace organization process at its manufacturing facilities to demonstrate its commitment to a superior level of cleanliness and orderliness required by its growing base of medical customers. The 5S program, which refers to steps taken to sort, set in order, shine, standardize, and sustain, is an integral part of the company’s larger lean manufacturing initiatives.
Lumalier Corp., Memphis, TN, has dispatched two of its TRU-D SmartUVC™portable UV disinfection devices to the ELWA Hospital in Monrovia, Republic of Liberia, to help disinfect health care environments where Ebola patients are being treated.
Technetics Group, Houston, TX, a global resource for engineered components, seals, assemblies, and sub-systems, announces its newly redesigned website at www.techneticsgroup.com .
InfinityQS International, Inc., Fairfax, VA, a global authority on real-time quality and Manufacturing Intelligence, has been identified as a “Sample Vendor” in the Gartner Inc. “Hype Cycle for Process Manufacturing and PLM, 2014” and the Gartner Inc. "Hype Cycle for Supply Chain Execution Technologies, 2014" reports.
Automation Products Group, Inc., Logan, UT, has redesigned its website that enables users to identify the right sensor technology to suit specific application needs. The new site integrates product specifications with technical explanations and educational how-to articles and videos. See www.apgsensors.com .
The L.S. Starrett Company, Athol, MA, which manufactures precision tools, gages and instruments, saws, and hand tools, will host its first virtual exhibition from September 8-26, 2014. For more information, visit www.starrett.com .
Thomson Industries, Inc., Wood Dale, IL, a leading manufacturer of mechanical motion control solutions, has released a video introducing the new PC-Series precision electric linear actuators for continuous duty applications, optimized to help design engineers convert from pneumatic to electric linear actuation. The video is can be viewed at http://goo.gl/QWiyLu .
