Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Covidien, Dublin, Ireland, announced that the FDA has granted 510(k) clearance for the latest addition to its line of atherectomy devices, the HawkOne directional system for peripheral artery disease.
BioFire, Salt Lake City, UT, announced that the FDA has approved its FilmArray, which can screen patients for Ebola within an hour with 90 percent certainty.
Lombard Medical, Inc., Oxfordshire, UK, a medical device company focused on solutions for the abdominal aortic aneurysm repair market, announced that the FDA has cleared the way for manufacturing to commence at its new 10,000-square-foot cleanroom operation in the UK.
MEDICREA, Lyon, France, which specializes in personalized implants produced for a patient’s specific need to treat spinal pathologies, announced that the company has received FDA 510(k) clearance for UNiDTM, the world’s first patient-specific spinal osteosynthesis rod.
Zimmer Holdings, Warsaw, IN, which is acquiring Biomet, also Warsaw, announced the executive team that will lead the company after the acquisition, expected to close early next year. The combined companies will be renamed Zimmer Biomet. David Dvorak, President and CEO of Zimmer, will continue in those roles for the combined company. Heading up the business units will be: Adam Johnson, Group President for spine, microfixation, bone healing, and dental products; David Nolan, Group President for sports medicine, extremities, trauma, biologics, and surgical devices; and Daniel Williamson, Group President for knee, hip, and bone cement products.
Berkeley Research Group, Emeryville, CA, has expanded its team of top healthcare and life sciences compliance professionals with the additions of Rosemary Weghorstas a director and Katherine Norris as a principal in the firm’s Washington, DC, office.
Nordson Corporation, Westlake, OH, announces the launch ofNordson MEDICAL, Fort Collins, CO, a new brand that more clearly communicates to customers the combined excellence of the company’s Value Plastics precision plastic fluid components, Micromedics biomaterial delivery devices, and Avalon Laboratories catheters and tubing, along with a wide range of services and customized OEM solutions. Visitwww.nordsonmedical.com .
Integra LifeSciences, Plainsboro, NJ, a leading provider of orthopedic products and surgical instruments, will spin off its spine business, creating a new publicly traded company named SeaSpine, Vista, CA, focusing on spinal hardware and orthobiologics.
Vention Medical, South Plainfield, NJ, a global integrated solutions partner for design, engineering, and manufacturing of complex medical devices and components, has expanded its Catheter Center of Excellence in Minneapolis to include a 10,000 square-foot controlled manufacturing environment for catheter component and device production.
Lombard Medical, Oxfordshire, UK, a medical technology company specializing in developing, manufacturing, and marketing endovascular stent-grafts, announced that the FDA has approved manufacturing at its new 10,000-square-foot cleanroom facility in the UK to manufacture the Aorfix endovascular stent graft. The new UK site has also been cleared by Japan’s Pharmaceuticals and Medical Devices Agency and by TUV Rheinland.
Phillips-Medisize, Hudson, WI, announced that the company is undertaking a $30 million expansion at five facilities throughout Wisconsin—a move expected to create 484 new jobs in four counties.
Stratasys Ltd., Rehovot, Israel, a leading global provider of 3D printing and additive manufacturing solutions, announced its collaboration with design and product development company,Worrell, Minneapolis, MN, to accelerate medical device development through the use of 3D printed injection molding.
CoorsTek Medical, Ft. Worth, TX, was launched following the successful integration of IMDS and C5 Medical Werks, which began in late 2013. CoorsTek Medical will develop and manufacture orthopedic medical implants and instruments.
Mevion Medical Systems, Inc., Littleton, MA, and Philips Radiation Oncology Systems, Andover, MA, are collaborating to pair Philips' Pinnacle radiation therapy planning system with the MEVION S250, with HYPERSCAN, Mevion's new pencil beam scanning technology that can scan a tumor in a matter of seconds.
Abbott Laboratories, Abbott Park, IL, has acquired heart rhythm company Topera Inc., Menlo Park, CA, and secured the right to buy ablation therapy company Advanced Cardiac Therapeutics Inc., Santa Clara, CA, in the future.
Wright Medical Group, Inc., Memphis, TN, a specialty orthopaedic company, and Tornier N.V., The Netherlands, a global medical device company focused on musculoskeletal treatments, have entered into a definitive merger agreement.
Sterigenics International LLC, Deerfield, IL, a global provider of contract sterilization, gamma technologies, and medical isotopes, has acquired Gammarad, Bologna, Italy, whch provides gamma irradiation sterilization services for the biomedical, pharmaceutical, food packaging, and cosmetics industries in Italy.
PPC Industries Inc., Pleasant Prairie, WI, a medical plastics processor, was acquired by Kohlberg & Co., Mount Kisco, NY, a private equity firm, to accelerate PPC’s growth and provide a platform for acquisitions.
Intelligrated, Mason, OH, a leading automated material handling solutions provider, has expanded its international operations in Shanghai, China, São Paulo, Brazil, and Mississauga, Ontario, Canada to enhance customer support and increase market penetration.
Cardio3 BioSciences, Mont-Saint-Guibert, Belgium, a leader in the discovery and development of regenerative, protective and reconstructive therapies, has acquired U.S.-based CorQuest Medical Inc., Miami, FL, which specializes in the development of cardiovascular devices.
Southern Research Institute, Birmingham, AL, a not-for-profit 501(c)(3) scientific research organization, and the University of Alabama at Birmingham, a leading research institution, have partnered to develop new medical devices to improve healthcare in the US and around the globe.
The two winners of a competition at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System symposium on pediatric surgical innovation were Velano Vascular and REBIScan, who each won $50,000. Velano Vascular, Philadelphia, PA, and San Francisco, CA, developed a novel innovation that enables safe, effective needle-free blood draws for hospitalized children. REBIScan, Cambridge, MA, presented a handheld vision scanner to eradicate amblyopia, or lazy eye, a common childhood ailment.
Qualstar, Simi Valley, Ca, announces its new website at www.qualstar.com , featuring innovative data management/storage and power supply solutions.
Fairview Microwave Inc., Allen, TX, a supplier of on-demand microwave and RF components, has launched its all new RF/Microwave eCommerce website featuring a powerful specification-based navigation, enhanced site search capabilities and a newly designed user interface. See www.fairviewmicrowave.com .
FANUC Corporation, Rochester Hills, MI, a leading manufacturer of CNCs, robots, and ROBOMACHINEs, has been named one of the top 100 innovative companies in the world by Forbes. This is the fourth consecutive year Forbes has named FANUC a top global innovator.
GW Plastics, Bethel, VT, a top contract manufacturer for complex injection molded thermoplastic and silicone solutions, opened the doors to its Royalton, VT, facility to celebrate National Manufacturing Day 2014. In addition to thermoplastic injection molding, contract assembly, and packaging, that facility also houses GW Plastics Tool Division and Technology Center and GW Silicones.
Revolutions Medical, Charleston, SC, has donated 50,000 of its RevVac safety syringes to the AmeriCares Foundation, a nonprofit disaster relief and humanitarian relief organization to be used to help fight the Ebola outbreak in West Africa.
Bunting Magnetics Co., Newton, KS, has announced the company will donate $100,000 toward a new regional YMCA complex planned for construction in Newton, where Bunting Magnetics is based. The donation will aid the local area in meeting the $5 million in private funds necessary to move the project ahead.