Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
SafeOp Surgical, Inc., Greenwich, CT, has received FDA clearance to market its Evoked Potential Assessment Device (EPAD™), a neuromonitoring device.
Biosense Webster, Diamond Bar, CA, announced FDA approval of its Thermocool SmartTouch catheter, which allows surgeons to more precisely control the amount of contact force applied to the heart wall during catheter ablation.
Covidien, Mansfield, MA, plans to launch its Puritan Bennett 980 acute care ventilator in the US in coming months, following receipt of FDA 510(k) clearance, the company said. The 980 system is also approved in Canada and Japan and will be available in those countries in coming months as well.
Intellijoint Surgical Inc., Waterloo, Canada, received a Health Canada Medical Device License for the Intellijoint HIP. The device enables surgeons to quantify the key measurements needed for accurate primary and revision hip replacement.
IMRIS, Minneapolis, MN, announced that its VISIUS intraoperative computed tomography system has gained regulatory clearance in Australia.
InControl Medical, LLC and Apex®, two new proprietary, patented women’s urinary incontinence devices for women in Canada.
MedShape, Inc., Atlanta, GA, has received FDA 510(k) clearance for its Morphix® SP Suture Anchor featuring the company's new Scoria™ technology, a polyetheretherketone (PEEK) material.
Leadership News
Secant Medical, Perkasie, PA,has named Dawn Porter Eringis as Vice President, Business Development and Marketing.
Intact Vascular, Inc., Wayne, PA, which develops minimally invasive peripheral vascular products, announced the appointment of Joseph C. Griffin as Vice President of Regulatory Affairs and Quality Assurance.
Cook Medical, Bloomington, IN, announced the launch of its EchoTip ProCore Endobronchial Needle, an endoscopic device to help physicians and pathologists diagnose lung cancer earlier.
InfinityQS International, Inc., Fairfax, VA, an authority on real-time quality and manufacturing intelligence, announced its president and CEO, Michael Lyle, has been recognized by Supply & Demand Chain Executive in its 2014 list of “Provider Pros to Know.” This is his fourth time on the prestigious annual list.
Nelipak Healthcare Packaging, Cranston, RI, a leading provider ofcustom thermoformed medical device and pharmaceutical packaging, announced the promotion of Seán Egan to the role of Group Marketing Manager from his previous position of Business Development Manager for the group’s Irish operation.
ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products to industrial customers, announced that Timothy R. Pierce has joined the company as US Chief Operating Officer.
TriStar Wellness Solutions, Inc., Westport, CT, which develops, manufactures, and markets innovative technologies for hemostatic devices, has appointed Stuart Sands as Chief Financial Officer of its wholly owned subsidiary, HemCon Medical Technologies, Inc., Portland, OR.
ABILITY Network Inc., Minneapolis, MN, a leading healthcare technology company, announced that Ken Ernsting has been promoted to Chief Operating Officer for the organization.
DfR Solutions, LLC, Beltsville, MD, a leader in quality, reliability, and durability research and consulting for the electronics industry, announced a new appointment to its management team. Chris Montgomery will serve as Senior Vice President, in charge of Strategic Business Development and Marketing.
Bunting Magnetics Company, Newton, KS, a producer of precision magnetic products, has named Steve Swaney as Industrial Territory Manager, responsible for servicing Bunting customers in the Plastics, Recycling, Metal Stamping, and General Manufacturing industries in Kansas, Nebraska, North and South Dakota, Minnesota, Iowa, and Missouri.
ASTM International Committee F04 on Medical and Surgical Materials and Devices has named William Mihalko, MD, PhD, as its new chairman. He is professor and J.R. Hyde chair of excellence in biomedical engineering at the Campbell Clinic Department of Orthopaedic Surgery and Biomedical Engineering at the University of Tennessee in Memphis, TN.
Caliber Imaging & Diagnostics, formerly Lucid, Inc., Rochester, NY, has named Anthony J. Roberto as East Coast Sales Manager, a newly created position, to further develop sales initiatives for its VivaScope® platform.
Expansions/Moves
To better support customers in the Asia region, Davis-Standard, Pawcatuck, CT, a global leader in the design, development, and distribution of extrusion and converting technology, announced the opening of its Spare Parts and Service Center located at the company’s manufacturing facility in Suzhou, China.
Mergers/Acquisitions/Collaborations/Spinouts
The Alfred Mann Foundation, Santa Clarita, CA, announces the creation of Medallion Therapeutics, Inc., Minneapolis, MN, company formed to provide targeted delivery solutions for pharma and biologic therapies based on implantable drug delivery infusion pump technology.
Avalon Laboratories, Rancho Dominguez, CA, a leader in the manufacture of wire reinforced cannulae for cardiac surgery, has partnered with Diablo Sales and Marketing, Diablo, CA,torepresent Avalon in Arizona, British Columbia, California, Colorado, Florida, Georgia, Hawaii, Idaho, Kansas, Louisiana, Montana, Nebraska, Nevada, New Mexico, North and South Dakota, Oklahoma, Oregon, Texas, Utah, Washington, and Wyoming. The company has also partnered with Symphony Sales torepresent Avalon in Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North and South Carolina, Pennsylvania, Rhode Island, Vermont, and Virginia.
Gowanda Electronics, Gowanda, NY, a designer and manufacturer of precision electronic components and inductors for power, radio frequency (RF), and high frequency applications, is teaming up with its recently acquired sister company, TTE, Inc., Los Angeles, CA, which manufactures RF and microwave filters, to provide a broader range of electronic components to the global design engineering community.
Terso Solutions, Inc., Madison, WI, and Helmer Scientific, Noblesville, IN, have partnered to offer fully automated tracking of high value refrigerated inventory including pharmaceuticals, reagents, and medical devices. Terso's patented RFID technology has been integrated into Helmer's 20 cubic foot medical-grade refrigerators.
Intronix Technologies, Toronto, Canada, announced that NeuroSource Medical, London, Ontario, Canada, is their new Canadian distributor for the Myoguide™ Needle EMG Guided Injection System.
Melexis Technologies NV, Tessenderlo, Belgium, is pursuing a major expansion in the global reach of its innovative mixed signal and sensor ICs. To further this goal across China, Melexis and Sekorm Ltd., Hong Kong, have signed a franchised distribution agreement authorizing Sekorm to resell Melexis ICs.
Miscellaneous
Mazak, Florency, KY,invites medical manufacturers to its DISCOVER MORE WITH MAZAK Technology and Education Event, taking place May 6 and 7 at the company’s Northeast Technology Center in Windsor Locks, CT. To learn more, visit www.mazakusa.com/morenortheast .
igus®, East Providence, RI, was presented with three iF Design Awards for its innovative products: the R4.1 light Energy Tube for cable protection, DryLin SLT linear guide for small installation spaces, and ReadyChain rack mounting/transport frame. The iF design awards are one of the largest international design competitions.
Millstone Medical Outsourcing, Fall River, MA, has successfully launched version 12.1.3 of Oracle’s E-Business Suite application. To further enhance all aspects of its ERP system, it has also contracted with cloud-based data center, Rackspace, to host its Oracle applications and provide backup.
The Advanced Medical Technology Association (AdvaMed) has entered into a memorandum of understanding with three key Brazil device associations to facilitate cross-border harmonization of ethical business practices among manufacturers, third-party distributors, and health care professionals in Brazil. They include: Associação Brasileira da Indústria de Alta Tecnologia de Equipamentos, Produtos e Suprimentos Médico-Hospitalares; Associação Brasileira de Importadores e Distribuidores de Implantes; and Câmara Brasileira de Diagnóstico Laboratorial.
The inventor of the modern laminar-flow cleanroom, Willis Whitfield, will be honored posthumously by the National Inventors Hall of Fame for his technology that revolutionized manufacturing in electronics and pharmaceuticals, made hospital operating rooms safer and advanced space exploration. He is among 15 inventors being inducted this year into the Alexandria, Va.-based National Inventors Hall of Fame.
