Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approvals, Standards, and Launches

FUJIFILM SonoSite Inc., Bothell, WA, specialists in developing ultrasound solutions and education to enable point-of-care visualization access, announced that it has received CE Mark and FDA 510(k) clearance for its new portable ultrasound system, the SonoSite Edge II.

The Orthopaedic Implant Company, Reno, NV, which is developing lower cost implant technology for a variety of procedures, announced the launch of its Intramedullary Hip Nail System.

Verathon Inc., Bothell, WA, a leading manufacturer and marketer of imaging and respiratory medical device solutions, has launched its new portable 3D ultrasound instrument: BladderScan Prime.

Integral ElectroMagnetronic Technologies LLC, Montvale, NJ, has received US patents for technologies used in a novel portable and relatively low-cost laptop-sized medical imaging device that can be used by both first responders and professional practitioners.

Leadership News

SpineGuard, Paris France, and San Francisco, CA, which develops and markets disposable medical devices to make spine surgery safer, announced the addition of Steve McAdoo as Vice President of Business Development.

C2 Therapeutics, Redwood City, CA, a medical device company founded to improve methods of eradicating unwanted tissue in endoscopic applications, announced the appointment of five new members to its leadership team: Jennifer Lloyd Halsey was named a Senior Executive in strategy and finance, Ryan Brennan was named Vice President of Sales, Lisa Bichsel was named Vice President of Marketing, Quentin Manley was named Vice President – Europe, and Linda Raggi was named Vice President of Finance.

Biocorp, Issoire, France, which specializes in the development and manufacturing of innovative medical devices and drug delivery systems, announced the appointment of Robert Kilgore as Senior Advisor in the US.

Stryker Corporation, Kalamazoo, MI, a leader in the worldwide orthopaedic medical technology market, has announced that William R. Jellison, the company’s Vice President and Chief Financial Officer, has announced his plans to retire at the end of the first quarter. Glenn S. Boehnlein, currently CFO for MedSurg & Neurotechnology, will assume the role of VP and CFO, effective April 1.

MEPS Real-Time, Inc., Carlsbad, CA, a leading innovator of RFID solutions for healthcare industries, has promoted Valerie Fritz to Vice President of Marketing and hired Paula Dycaico as Director of Product Management. The company’s engineering, operations, and client support departments have added a senior project engineer and technical support staff. MEPS is in the process of recruiting additional implementation, quality assurance, product management, marketing, and software personnel, and has expanded its headquarters by nearly 40 percent.

Royal Philips, Andover, MA, and Amsterdam, The Netherlands, a leader in cardiac care, acute care and home healthcare, has appointed Jean Botti as chief innovation and strategy officer, as part of the company’s effort to capture a larger portion of HealthTech opportunities.

SynDaver Labs, Tampa, FL, a manufacturer of synthetic humans for medical training purposes, has promoted William Wright to the newly created rank of Darth Vader, aka Vice President of Operations.

Dymax Corporation, Torrington, CT, which develops oligomer, adhesive, coating, dispensing, and light-curing systems, announced the appointment of Steven Suzuki as Global Account Manager for the Western Region.

LineGard Med, Little Rock, AR, which developed a medical device that prevents dislodgement and pull-outs of medical tubing, has added two new members to its executive team. Vance Clement joins the company as Chief Operating Officer and Jordan Mykleby as the Director of Engineering.

Expansions/Spinoffs/New Services/Moves

Metabolix, Inc., Cambridge, MA, an advanced biomaterials company focused on sustainable solutions for the plastics industry, signed a 10.5 year lease agreement for a new headquarters and laboratory space in Woburn, MA, and expects to occupy the space in June.

Axis Research & Technologies, Irvine, CA, a medical and educational research facility, opened its 10,100 square-foot stand-alone facility as a technologically sophisticated training ground for medical device manufacturers, surgeons, and hospitals.

Olympus Corp. of the Americas, Center Valley, PA, a precision technology leader, designing and delivering innovative solutions in its core business areas of medical and surgical products, scientific solutions, and cameras and audio recorders, has announced that it will build a service and distribution center for medical equipment in Bartlett, TN, creating 280 jobs over the next five years.

Phillips-Medisize Corp., Hudson, WI, a global-leader in outsource design, development, and technology-driven manufacturing, recently added a 17,000 square foot clinical and pilot facility, dedicated to medical device and drug delivery device, in Menomonie, Wisconsin. This will allow customers to validate their product, manufacturing process, and assembly activities as part of the clinical trial regimen.

NPI/Medical, Ansonia, CT, focuses on helping customers quickly bring new products to market through a full range of product development services including prototyping, tooling, and production molding. As a leader in providing services to the medical device industry, the company announced an expansion of its kitting and assembly operations via a dedicated climate controlled kitting room in a white room environment. NPI/Medical can accommodate 500+ kits per day, depending upon customer needs.

Averna, Montreal, Canada, an industry-leading provider of test solutions and services for communications and electronics device-makers worldwide, announced the opening of an RF and FPGA Innovation Lab at its US headquarters in Atlanta, GA, which will act as Averna’s Center of Excellence for all projects related to ITAR, RF signal processing, and LabVIEW FPGA and VHDL.

The University of Delaware, Newark, recently opened its new $30 million nanofabrication facility. The 8,500-square-foot clean room houses the most advanced nanotechnology machinery in the mid-Atlantic region—allowing students, researchers, and local startup companies the ability to conduct their research right on the university’s campus.

Mergers/Acquisitions/Collaborations/Licensing

Vention Medical, South Plainfield, NJ, a global integrated solutions partner in design, engineering, and manufacturing of complex medical devices and components, is partnering with DSM, Exton, PA, a global leader in biomedical materials, to offer customers the option of integrating the development, testing, and application of hydrophilic lubricious coatings into the catheter manufacturing process, which will strengthen Vention’s position as a single-source solution for catheter-based device design, development, manufacturing, and assembly.

Medtronic plc, Dublin, Ireland, one of the world’s largest medical technology companies, has acquired Bellco, Mirandola, Italy, a pioneer in hemodialysis treatment solutions.

TE Connectivity Ltd., Schaffhausen, Switzerland, a world leader in connectivity and sensors, has entered into a definitive agreement to acquire the Creganna Medical, Galway, Ireland, a global leader that designs and manufactures minimally invasive delivery and access devices serving medical device original equipment manufacturers.

Aurora Resurgence, Los Angeles, CA, a leading private equity firm, has completed its acquisition of the assets of Cardiac Science, Waukesha, Wi, concluding the restructuring of the automated external defibrillator company.

Stryker Corp., Kalamazoo, MI, a leader in the worldwide orthopaedic medical technology market, has acquired Sage Products LLC, Cary, IL, a developer of devices for preventing hospital-acquired infections. Sage will be folded into Stryker's medical division but continue to operate under its own name and existing leadership.

UltraTape Industries, Wilsonville, OR, a division of Delphon, and a leading manufacturer of cleanroom tape, labels, and custom adhesive material products, has completed its acquisition of High Tech Graphics, Sherwood, OR, which manufactures custom graphic overlays and provides material coating services to a wide range of industrial customers.

Abbott, Abbott Park, IL, a global healthcare company specializing in diagnostics, medical devices, nutritionals, and pharmaceuticals, has acquired Kalila Medical, Campbell, CA, a medical device company developing next-generation access technologies used in cardiac electrophysiology procedures to treat heart rhythm disorders.

COMSOL, Burlington, MA, a leading provider of multiphysics modeling, simulation, and application design software, announces support for app development in the latest version of LiveLink™ for SOLIDWORKS®. Part of COMSOL Multiphysics® software, LiveLink™ for SOLIDWORKS connects COMSOL software simulations and 3D design, and its latest version allows users to build apps with the Application Builder.

Henkel Adhesive Technologies, Irvine, CA, whichdevelops innovative electronic materials, has held a long-time business relationship with global distributor Ellsworth Adhesives, Germantown, WI, a global leader in specialty chemicals. That relationship now includes Moldman Systems LLC, Reno, NV, a a leader in low-pressure molding, which was acquired by Ellsworth Corporation in 2014.

Senseonics Holdings, Inc., Germantown, MD, a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring system for people with diabetes, has signed a collaboration agreement with Diasend, Gothenburg, Sweden, which transmits, stores, and analyzes data from different glucose meters, that will allow clinical review of patient data.

Cantel Medical Corp., Little Falls, NJ, which is dedicated to delivering innovative infection prevention and control products, has entered into a definitive agreement with North American Science Associates, Inc. (NAMSA), Northwood, OH, a medical research organization providing regulatory, laboratory, clinical, and compliance services, to acquire NAMSA's Sterility Assurance Monitoring Products division.

Miscellaneous

MasterControl, Salt Lake City, UT, a leading global provider of enterprise quality management systems and quality consulting services, and Underwriters Laboratories (UL) LLC, a global safety consulting and certification company, will host the second installment of a complimentary webinar series on FDA inspections. The live webinar: The FDA Just Left – Now What? will be held February 17 at 11:00 am EST. For more information and to register, visit http://www.uleduneering.com/news-events/webinars/february-17-fda-just-left-now-what/ 

The Motion Control & Motor Association will be hosting a webinar on “Theory, Application & Operation of Frameless Motor Technology” on February 23 at 11:00 AM. For more information, visit http://www.motioncontrolonline.org/webinars-detail.cfm?id=283  .

The Society of Plastics Engineers (SPE), Bethel, CT, and SpecialChem, Paris, France, announced a partnership that will offer SPE members full access to SpecialChem’s Universal Selector database of plastics and additives, which includes 125,000 datasheets. For mre information, visit www.4spe.org. 

Hexagon Manufacturing Intelligence (formerly Hexagon Metrology), North Kingstown, RI, a leading metrology and manufacturing solution specialist, announced that its WLS qFLASH vision measurement system, a non-contact, optical shop-floor system that uses advanced blue LED high-power illumination for portable 3D measurement, has won a distinguished GOOD DESIGN Award from the Chicago Athenaeum Museum of Architecture and Design.