Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
ZOLL® Medical Corporation, Chelmsford, MA, a manufacturer of medical devices and related software solutions, announced that the FDA has grant a premarket approval to market and begin US distribution of the company’s ResQCPR™ System, a CPR adjunct system.
Advanced Bionics, Valencia, CA, a global leader in cochlear implant technology announced today that its HiRes 90K™ Advantage cochlear implant, with the HiFocus™ 1J, HiFocus Helix™, and HiFocus™ Mid-Scala electrodes, has received the CE Mark.
Bioness, Inc., Valencia, CA, has received FDA 510(k) clearance for its Stimrouter, an implantable neuromodulation device designed to treat chronic, intractable pain.
AqueSys, Inc., Aliso Viejo, CA, a developer of minimally invasive stent technology to treat glaucoma, has received a Class 3 Medical Device License for its XEN Gel Stent from Health Canada, allowing the device to be sold in Canada.
Noxilizer, Inc., Baltimore, MD, a provider of room temperature, nitrogen dioxide-based sterilization solutions, announced that it has received the CE Mark for its RTS Series Sterilizers under the Medical Device Directive.
Life Spine, Huntley, IL, which designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that it has received FDA 510(k) clearance for 40 transition connector implants to its thoracolumbar and cervical systems.
General Microcircuits, Inc., Mooresville. NC, which provides circuit board and integrated assemblies, successfully completed an intensive audit based on IPC J-STD-001, Requirements for Soldered Electrical and Electronic Assembliesand IPC-A-610, Acceptability of Electronic Assemblies from the IPC, Bannockburn, IL.
TomTec Imaging Systems GmbH, Munich, Germany, has received FDA 510(k) clearance for the latest version of its TomTec-ArenaTM software.
JustRight Surgical, Boulder, CO, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received CE Mark approval for all of its FDA-cleared devices.
Tornier N.V., Amsterdam, The Netherlands, focused on providing surgical solutions to orthopaedic extremity specialists, has received FDA clearance to market its Simpliciti™ Shoulder System, a bone-sparing total shoulder arthroplasty system to treat severe shoulder joint pain.
Leadership News
Shawn Campion, President of Integro Technologies, Salisbury, NC, an innovator in machine vision and system integration providing turnkey solutions, consulting, and support services for a wide range of industries, received an “Emerging Leader” award at the Charlotte Business Journal’s third annual Advanced Manufacturing Awards.
COR Medical Technologies, Houston, TX, which offers an instant decision support system for rapid and accurate diagnosis, treatment, and follow-up management of patients with diseases involving the cardiovascular system, announced that Dr. Robert Roberts has been appointed to its Senior Editorial Board.
ICON plc, Dublin, Ireland, a global provider of drug development solutions and services to the pharmaceutical, biotechnology, and medical device industries, has launched a new Medical Device & Diagnostics Research group focused on the unique requirements of the medical device and diagnostics industry. It will be led by Vicki Anastasi, Vice President, Medical Device & Diagnostic Research.
Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the medical device industry, announced that John Sills has been appointed Chief Financial Officer, effective March 15. He will succeed E. Gary Willenbrecht, Chief Financial Officer, who will retire from the company.
ENMET, LLC, Ann Arbor, MI, which supplies gas and vapor detection instruments for industrial health and safety applications, announced the appointment of Norman Davis, Jr., as the company’s new president.
Intelligrated®, Mason, OH, a leading automated material handling solutions provider, announces the promotion of Tracy Perdue to the position of sales manager for its southern regional sales and operations, based in Alpharetta, GA.
Expansions/Spinoffs/New Services/Moves
Brainlab, Munich, Germany, which develops, manufactures, and markets software-driven medical technology, has opened a new office in the Wrigley Building in Chicago, IL.
Varian Medical Systems, Palo Alto, CA, which develops medical devices and software to treat cancer, plans to open a new facility in November in Atlanta, GA, as an East coast hub, adding 100 jobs.
Mergers/Acquisitions/Collaborations/Licensing
PolySource, LLC, Kansas City, MO, a distributor of thermoplastic resins and compounds, has signed an agreement with Hyosung Group of South Korea to be an authorized distributor for polyketone in North America. Hyosung is the world’s only producer of polyketone.
Transcat, Inc., Rochester, NY, a leading provider of accredited calibration and compliance services and distributor of professional grade handheld test, measurement, and control instrumentation, has acquired Apex Metrology Solutions, Ft. Wayne, IN, a provider of accredited and commercial calibrations.
Boston Scientific Corporation, Marlborough, MA, has entered into a definitive agreement with Endo International plc, Dublin, Ireland, to acquire its American Medical Systems, Minnetonka, MN, urology portfolio, which includes the Men's Health and Prostate Health businesses, which will become part of Boston Scientific Urology and Women's Health.
Cardinal Health, Dublin, OH, a health care services company, announced plans to acquire Johnson & Johnson's Cordis business, Fremont, CA, a leading global manufacturer of cardiology and endovascular devices.
Sorin S.p.A., Milan, Italy, a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., Houston, TX, a medical device company with core expertise in neuromodulation, announced a merger plan to create a new global leader in medical technologies, which the parties will name prior to closing.
Globus Medical, Inc., Audubon, PA, a leading musculoskeletal implant manufacturer, has entered into an agreement to acquire Branch Medical Group, Inc., also Audubon, PA, a third party manufacturer of high precision medical devices.
Interstate Batteries, Dallas, TX, a major battery supplier, is teaming up with Anton/Bauer, Shelton, CT, which designs and manufactures high quality medical mobile power systems, to market the company’s new battery system designed for hospital mobile workstations.
Honeywell Fluorine Products, Morris Township, NJ, announced that KYZEN, Nashville, TN, which distributes and develops environmentally responsible cleaning technologies and engineering services, has become a national distributor of Honeywell’s Solstice Performance Fluid, a new solvent used to clean metal and plastic parts for the electronics and medical device manufacturing industries.
Graphic Controls, Buffalo, NY, a leading supplier of consumable products for the industrial, medical and gaming markets, has acquired Vermed, Bellows Falls, VT, which makes medical devices, electrodes, and topical skin adhesives.
Brookhaven Medical, Inc., Atlanta, GA, an emerging developer, manufacturer, and marketer of innovative medical technologies and solutions, has announced the acquisition of FutureMatrix Interventional, Athens, TX, and CreatiVasc Medical, Inc., Greenville, SC. The two acquisitions have collaborated for two years to develop an advanced balloon technology aimed at reducing complications during dialysis treatment.
Miscellaneous
Littelfuse, Inc., Chicago, IL, a global leader in circuit protection, announced that its SDP0240T023G6 SIDACtor® protection thyristor solution has been honored with the “Intelligent Industry Outstanding Solution Award” in the 2013-2014 China Best IC and Electronic Products Solution Award program. The award was based on five criteria: solution integrity, cost performance, usability, application scope, and innovation.
Nordson ASYMTEK, Carlsbad, CA, a global leader in dispensing, jetting, and coating equipment and technologies, was presented with two prestigious industry awards at IPC APEX 2015. Both the 2015 Service Excellence Award and 2015 New Product Introduction Award for electronics assembly equipment, materials, and software were won in the Dispensing Equipment category.
H.C. Starck, Munich, Germany, a leading manufacturer of technology metals and advanced ceramics, announced that its tantalum supply chain has been again declared free of “conflict minerals” following an independent audit conducted by a third party auditor assigned by the Electronics Industry Citizenship Coalition and Global e-Sustainability Initiative as part of the Conflict Free Smelter Program.
TRUMPF, Ditzingen, Germany, a world leader in sheet metal fabrication machinery and industrial lasers, recently produced its thousandth TruPunch 1000 punching machine. The machine was shipped to Watlow, Hannibal, MO, an industry-leading producer of thermal solutions including electric heaters, temperature sensors, power controllers, temperature controllers and supporting software.
Watson-Marlow Pumps Group, Falmouth, UK, has changed its name to Watson-Marlow Fluid Technology Group to better reflect its current position as a world leader in fluid path technology.
Kent Elastomer Products, Inc., Kent, OH, a manufacturer of latex and non-latex tubing and dip-molded components, has received an Evolution of Manufacturing Award for its commitment to lean manufacturing methods. Sponsored by Smart Business Network, Inc. and presented by Cuyahoga Community College, the award recognizes the company’s demonstrated excellence in process improvement.
Stratasys Ltd., Minneapolis, MN, and Rehovot, Israel, a global leader of 3D printing and additive manufacturing solutions, has introduced a new recycling program for North American customers. The program provides a code-compliant and free-of-charge system for disposing of waste FDM canisters and PolyJet cartridges. Recycling is carried out at the Stratasys Eden Prairie, MN, facilities, in collaboration with a nonprofit organization serving people with disabilities.
