Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Siemens Healthcare, Malvern, PA, a leading provider of medical imaging equipment, has received FDA clearance for its Multitom Rax (Robotic Advanced X-ray), a universal diagnostic imaging system that enables a wide range of examinations in multiple clinical all in one room using one X-ray system.
Greatbatch, Inc., Frisco, TX, one of the largest medical device outsource manufacturers in the world, has received FDA approval for its Algovita® Spinal Cord Stimulation System to treat chronic intractable pain of the trunk and/or limbs.
Boston Scientific, Marlborough, MA, a global medical technology leader, has received FDA approval and the CE Mark for its AngioJet ZelanteDVT thrombectomy catheter to treat deep vein thrombosis in large-diameter upper and lower limb peripheral veins.
Teleflex Medical OEM, Gurnee, IL, a global leader in custom sutures and fibers, was granted a standard patent by the Hong Kong Patent Registry. Patent No. HK1088258 covers a coreless braid design constructed of ultra-high molecular weight polyethylene, which is the key technology for Teleflex Medical OEM’s Force Fiber® Suture.
Teledyne DALSA Inc., Waterloo, Canada, a global leader in X-ray image sensing technology, is launching its CMOS X-ray detector for mammography.
EDDA Technology, Princeton, NJ, a leading provider in advanced imaging-guided precision treatment solutions, announced that the company has received FDA clearance on IQQA®-Guide, a system that supports intra-operative precision 3D navigation for surgical procedures of thoracic, abdominal, and pelvic soft-organs.
XENIOS, Heilbronn, Germany, announced that its i-cor®Synchronized Cardiac Assist System has received the CE Mark and can now be sold in Europe as the world’s first heartbeat-synchronized cardiac assist for cardiogenic shock and high-risk interventions.
Covalon Technologies Ltd., Mississauga, Canada, an advanced medical technologies company, has received FDA clearance for its new SilverCoatTM Silicone Foley Catheter that is designed to allow clinicians to drain a patient's bladder.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, has received the CE Mark for magnetic resonance conditional-labeling for its Quadra Assura cardiac resynchronization therapy defibrillator.
Oticon Medical, Somerset, NJ, a global company in implantable hearing solutions, announced that the FDA has cleared two new Oticon Medical offerings for marketing in the US: Minimally Invasive Ponto Surgery for use with the company’s Ponto System and the Ponto BHX Implant, which is the first implant with a laser-ablated titanium surface to promote faster and stronger bonding to bone.
DSM Biomedical, Exton, PA, a global leader in biomedical materials science and regenerative medicine, announced that the FDA has cleared the Dyneema Purity® Radiopaque Cerclage Cable for use in orthopedic trauma treatments, such as treatment of bone and spine fractures.
Medtronic plc, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, announced that systems within its Activa® portfolio of Deep Brain Stimulation neurostimulators have received FDA approval for full-body magnetic resonance imaging under specific conditions of use. They are the only such systems approved for full-body MRI scans.
RevMedX, Wilsonville, OR, which is designing, developing, and manufacturing a portfolio of devices designed specifically for combat medics and civilian first responders, has received FDA approval to introduce its XStat 30 Rapid Hemostasis System for treating gunshot wounds in the civilian population. Last year the device received FDA clearance to be used on the battlefield,
Leadership News
Sussex Wire Inc., Easton, PA, which specializes in the design, manufacturing, and distribution of highly-engineered, specialty metal parts and components, has appointed Marian Watkins as Marketing Director.
Delphinus Medical Technologies, Inc., Plymouth, MI, a leader in advanced breast ultrasound technology, has appointed Francis X. Dobscha as its new Vice President of Quality and Regulatory Affairs.
Sunshine Heart, Inc., Eden Prairie, MN, an early-stage medical device company focused on developing, manufacturing, and commercializing its C-Pulse System to treat heart failure, announced that its Chief Executive Officer, David A. Rosa, is leaving the company, and that John L. Erb, Chairman of the company’s Board of Directors, has been named Interim Chief Executive Officer and President and will continue to serve as Chairman of the Board.
VEXIM, Toulouse, France, a medical device company focusing on the minimally invasive treatment of vertebral fractures, has named Steve Swinson the new Chairman of its Board of Directors.
StimGuard LLC, Fort Lauderdale, FL, engaged in the development, manufacture, and commercialization of wirelessly powered, implantable, microtechnology neurostimulators, announced the appointment of Tom R. Moore as President.
Surgical Theater, Cleveland, OH, a leader in the field of Virtual Reality and Image Guidance software for surgery, has appointed Jim Breidenstein as President and Chief Operating Officer of its SNAP Division.
J-Pac Medical,Somersworth, NH, an outsourcing partner for solutions customized to meet the needs of the medical device and diagnostic industries, has announced the appointment of Jeff Barrett as President and CEO.
Cadence, Inc., Staunton, VA, a single source contract manufacturing partner, announced that Jeff Kelly has joined the company as Vice President and General Manager of its finished device and plastic injection molding division.
Insulectro, Lake Forest, CA, a leading distributor of materials for use in the PCB and printed electronics industries, has announced that Patrick Redfern becomes President of Insulectro succeeding Tim Redfern who held the position for 12 years. Redfern will become Managing Director of Redfern Partners, LLC where he will lead the efforts to identify and integrate strategic acquisitions that will utilize Insulectro’s and the other Redfern Companies’ capabilities and resources.
Expansions/Spinoffs/New Services/Moves
Varian Medical Systems, Palo Alto, CA, one of the world’s leading manufacturers of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy, unveiled its East Coast hub in Marietta, GA, to support Velocity Medical Solutions, an Atlanta, GA, clinical intelligence company that Varian purchased last year.
AXYZ International, Burlington, Ontario, Canada, a leading global manufacturer of CNC router and knife cutting systems, has opened a new sales office and showroom in Burlington, designed to accommodate a large demonstration facility, and housing four of the larger machines, including AXYZ, Pacer, Trident and Z series machines. The new facility allows for more application development and support for customers with material or application queries.
BIT Group, Irvine, CA, has established a comprehensive medical instrument outsourcing manufacturing operation in Shenzhen as a joint venture with EDAN Instruments, Inc., Shenzhen, China. While BIT has operated an ISO9001 certified parts and modules manufacturing facility in China for several years, this new venture delivers increased capabilities, capacity, and a focus in IVD instrument contract manufacturing.
Victrex, Thornton Cleveleys, UK, a leading global high-performance aromatic polyketone solutions provider announced that it will build a new PEEK composite facility for unidirectional tape and add new manufacturing capability for medical trauma plate applications at its UK headquarters.
Covalon Technologies, Mississauga, Ontario, Canada, an advanced medical technologies company, has established a wholly owned foreign entity and office in Shanghai, China to service the healthcare markets in China and Asia.
Mergers/Acquisitions/Collaborations/Licensing
Pexco LLC, Alpharetta, GA, a specialty plastics manufacturer across multiple markets, has acquired Precision Extrusion, Inc., Glens Falls, NY, a dual-certified ISO 9001 and ISO 13485 manufacturer of advanced medical tubing and catheter solutions.
Flextronics International Ltd. (Flex), San Jose, CA, a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world, has acquired Farm Design, Hollis, NH, a full-service, ISO 13485-certified and FDA-compliant product development company providing development and design services for medical device and diagnostic companies.
Technimark, Asheboro, NC, a global manufacturer of custom rigid plastic packaging and components, announced its acquisition of Ci Medical Technologies, Latrobe, PA, a specialty medical component company specializes in product development, scientific molding, contract manufacturing, assembly, packaging and logistics.
BioPlast Manufacturing LLC, Bristol, PA, has expanded its line of plastic laboratory disposables by acquiring the manufacturing assets for injection molded polystyrene petri dishes from Kord-Valmark, Sandusky, OH. BioPlast will move nine injection presses to Bristol from the Kord-Valmark facility.
Clariant, Muttenz, Germany, a world leader in specialty chemicals, announced that its Healthcare Packaging business unit has entered into a joint promotion agreement with FreeThink Technologies Inc., Groton, CT, to support pharmaceutical and nutraceutical customers with predictive calculation and modeling.
CONMED Corporation, Utica, NY, which provides surgical devices and equipment for minimally invasive procedures, has signed a definitive agreement to acquire SurgiQuest, Milford, CT, which develops, manufactures, and markets the AirSeal System, an integrated access management technology for use in laparoscopic and robotic procedures. Kurt Azarbarzin, SurgiQuest’s founder and CEO, will join CONMED as Chief Technology Officer.
Milacron Holdings Corp., Cincinnati, OH, a leading industrial technology company serving the plastics processing industry, has completed its acquisition of CanGen Holdings, Inc. Atlanta, GA, consisting of subsidiaries Canterbury Engineering Company and Genca. CanGen is a leading supplier of highly engineered aftermarket process control components for extrusion and injection molding applications and will now be part of the Milacron Extrusion product offering.
Photo Stencil, LLC, Colorado Springs, CO, a leading full-service provider of high-performance stencils and tooling, announces that it has sold the Photo Stencil business in Guadalajara, Mexico, to the facility's management team, Francisco Lujano and Armando Berumen. Photo Stencil's Mexico facility produces laser-cut stencils and will continue to sell both the laser-cut stencils they manufacture and electroform stencils that will be made by Photo Stencil in its new Golden, CO, facility.
Piper Plastics, Chandler, AZ, a leading provider of high-performance polymer materials and precision machined plastic components and assemblies, announced that Laird Plastics Inc., Boca Raton, FL, a leading independent plastics distribution, manufacturing, and recycling solution provider, has been selected as the distributor for its KyronMAX™ S-6230 machinable carbon composite polyetherimide plate in North America.
Miscellaneous
NewAge Industries, Southampton, PA, which manufactures plastic and rubber tubing in both reinforced and unreinforced styles, has increased its engineering abilities considerably with the hiring of additional team members dedicated to engineering functions. Job titles Department . Members of the team hold ASQ (American Society for Quality) certifications such as Lean Six Sigma Green Belt.
Heraeus, Hanau, Germany, a global materials technology group, announced that the winner of the Konrad Ruthardt Award for the “Best Heraeus Innovation,” one of this year’s Heraeus Innovation Awards, is CerMet, a composite material made of ceramic and platinum that will allow future miniaturized medical implants to have smaller, more robust, and more advanced electrical feedthroughs only two times thicker than a human hair. In addition, the material won the first-time Customer Focus Award, which acknowledges the best innovation from the customers’ point of view.
Following the sale of some of the activities of its portfolio (Brands: BEI Kimco, BEI Sensors, Kavlico, Crydom, and Newall), the company called Custom Sensors & Technologies, Thousand Oaks, CA, is reorganizing. As of December 1, a new company name InnoVista Sensors™ has been created with the Crouzet Aerospace, Crouzet Automation, Crouzet Control, Crouzet Motors, Crouzet Switches, and Systron Donner Inertial commercial brands.
The Sherwin-Williams Company, Cleveland, OH, announced plans today to commit $1 million toward materials research through the Institute for Advanced Materials at Case Western Reserve University.The funding will support collaborative projects aimed at creating innovative designs in coating technologies.
Phillips-Medisize, Hudson, WI, a global-leader in outsource design, development, and technology-driven manufacturing, was the recipient of this year’s In-Mold Decorating Association’s Best In-Mold Decorated Part Gold award. The company enabled its customer to launch 20 different designs for their health and beauty product within the first year.
Alphabet, the parent company of Google Inc., Mountain View, CA, the multinational technology company, has renamed its Google Life Sciences division as Verily Life Sciences. The division is focused on using technology to make advancements in understanding disease and on improving human health.Following that announcement,Johnson & Johnson, New Brunswick, NJ, one of the world’s largest healthcare and medical device companies, announced a collaboration with Verily to create an independent surgical solutions company, Verb Surgical Inc., Mountain View, CA, that willdevelop robotic surgery platforms integrating advanced technologies.
Sterigenics International LLC, Deerfield, IL, a global provider of contract sterilization, gamma technologies, and medical isotopes, was named the 2015 Private Equity-backed Portfolio Company of the Year by the Illinois Venture Capital Association.
Nypro Healthcare, St. Petersburg, FL, a leader in design, manufacturing, and supply chain solutions to medical device and diagnostic companies, has been named a Supplier of the Year by Thermo Fisher Scientific.
