Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Cardiovascular Systems, Inc., St. Paul, MN, has received FDA clearance for its new ViperWire Advance® Peripheral Guide Wire with Flex Tip for their Peripheral Orbital Atherectomy Systems used to treat arterial calcium associated with peripheral artery disease.
Applied Silver, Inc., San Luis Obispo, CA, a pioneer in commercial applications of silver, launched SilvaClean®, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s 42nd Annual Conference at the end of June.
Exactech, Inc., Gainesville, FL, a developer and producer of bone and joint restoration products, has received FDA 510(k) clearance to market its Optetrak Logic Constrained Condylar Prosthesis for revision knee arthroplasty cases.
K2M Group Holdings, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing complex spine technologies, announced the US commercial launch of its MESA® 2 Deformity Spinal System, a next-generation pedicle screw system for complex spinal pathologies.
Proteus Digital Health, Inc., Redwood Shores, CA, announced that the FDA has expanded the Indications for Use statement for the latest generation of its Ingestible Sensor technology, enabling the device to be used to measure medication adherence.
Hansen Medical, Mountainview, CA, a global leader in flexible robotics, has received FDA 510(k) clearance for its Magellan 10Fr robotic catheter for use in peripheral vasculature.
Rivanna Medical, Charlottesville, VA, has received FDA 510(k) clearance to market Accuro™, its handheld and untethered smart phone-sized ultrasound device designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac, and peripheral vascular anatomies.
Leadership News
Waters Corporation, Milford, MA, which develops and manufactures advanced analytical science technologies, announced that Christopher J. O'Connellhas been appointed as its new President, Chief Executive Officer, and member of its Board of Directors, effective in September.
Second Sight Medical Products, Inc., Sylmar, CA, a developer, manufacturer, and marketer of implantable visual prosthetics, announced the appointment of Will McGuire as President and Chief Executive Officer, effective August 18.
FUJIFILM SonoSite Inc., Bothell, WA, a specialist in designing cutting-edge ultrasound tools and world-leading education for access to point-of-care visualization, announced the following changes in its executive leadership: Naohiro Fujitani was named Chairman, and Masayuki Higuchi was named President and CEO, succeeding Fujitani in this position. Both men were also appointed to the FUJIFILM SonoSite Board of Directors.
Orthofix International N.V., Lewisville, TX, a diversified global medical device company, announced that it has named Lilly Marks to its Board of Directors.
SCHURTER Inc., Santa Rosa, CA, which supplies components, input systems, and electronic manufacturing services announces the retirement of founder Bruno H. Schurter, President and CEO, who is stepping down after 33 years leading the company. Diane Cupples, Vice President of Marketing, will assume the position of Chairwoman of the Board, and Leonard Overholser, Vice President of Sales, will take over as President and CEO.
The Haselmeier Group, Zurich, Switzerland, a global medical device company and a leading designer and manufacturer of pen and auto injection systems, has announced that Gert Weber has been named Chief Executive Officer. Matthias Meissner was named Chief Quality Officer with two new groups reporting to him: Quality Management and Quality Assurance. Siegfried Eichinger has been appointed Chief Financial Officer.
Micrometal GmbH, Muellheim, Germany, a world leader in custom solutions for ultra-precision photo-chemically etched metal components for the dental, orthodontic, and medical industries, announced that Karl Martinson was named as Sales Director, North America. He will be based at Engineered Materials Solutions, Attleboro, MA, a co-member of the Wickeder Group.
IPC – Association Connecting Electronics Industries®, Bannockburn, IL, has promoted Philip Carmichael to IPC President of Asia.
FKP Architects, Houston, TX, involved in the than architecture in the healthcare, research, and education market sectors, announced that Jan Madey joined the company as Senior Project Manager and Laboratory Planner.
NuVasive, Inc., San Diego, CA, a leading medical device company focused on minimally disruptive, procedurally-integrated solutions for spine surgery, announced that Daniel J. Wolterman has been elected to the company’s Board of Directors.
Bunting Magnetics Co., Newton, KS, a leading manufacturer of magnetic separation, metal detection, and metals material handling equipment, has named Paul Hansen as Director of Marketing.
Expansions/Spinoffs/New Services/Moves
Amada Miyachi America, Inc., Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, announced that it has taken over the management, sales, and service of Amada Miyachi do Brasil Ltda. in all South American markets. The move will centralize all services in sales, marketing, and solution service programs offered by Amada Miyachi throughout the Americas.
Secant Medical, Perkasie, PA, which designs and manufactures biomedical textiles and other structures for medical devices, has moved its corporate headquarters to Telford, PA, as the first step in its expansion.
TSO3 Inc., Quebec, Canada, an innovator in sterilization technology for medical devices in healthcare settings, has formed a wholly owned subsidiary: TSO3Corporation, Myrtle Beach, SC. The new location is expected to open in August.
Glebar Company, Ramsey, NJ, an innovative engineering and manufacturing firm specializing in precision grinding systems used to manufacture parts for a wide range of industries, from medical and metals to automotive and aerospace, has consolidated its plants and office into a new 44,560-square-foot, fully integrated, state-of-the-art headquarters and manufacturing facility.
Mergers/Acquisitions/Collaborations/Licensing
DJO Global, Inc., Vista, CA, a leading global provider of medical device solutions for musculoskeletal health, vascular health, and pain management, announced that its subsidiary Encore Medical, L.P., dba DJO Surgical, Austin, TX, will purchase from Zimmer Holdings Inc., Warsaw, IN,Biomet Cobalt Bone Cement, Optivac Cement Mixing Accessories, and Discovery Elbow System for the US marketplace. Smith & Nephew, London, UK, will buy Zimmer’s unicondylar knee implant unit, which will close three days after the conclusion of Zimmer’s purchase of Biomet, Inc., Warsaw, IN. Zimmer will now operate as Zimmer Biomet Holdings.
Proto Labs, Inc., Maple Plain, MN, a leading custom prototyping and low-volume parts manufacturer, has teamed up with Autodesk, San Rafael, CA,to provide easy access to Proto Labs’ online quoting system directly within Autodesk’s Fusion 360. This software integration will go live with a late-July release of the Fusion 360 application update.
Corning Inc., Corning, NY, one of the world's leading innovators in materials science, has purchased the pharmaceutical glass tubing business of Gerresheimer AG, Dusseldorf, Germany, a global leader in the manufacture of glass and plastic packaging products for the health care industry. Corning will assume ownership of Gerresheimer's glass tubing operations in Vineland, NJ, and Pisa, Italy. Corning and Gerresheimer will also enter into a long-term supply agreement for pharmaceutical glass tubing.
Integra LifeSciences Corp., Plainsboro, NJ, a world leader in orthopedic products and surgical instruments, has agreed to acquire TEI Biosciences, Waltham, MA, a leader in regenerative medicine, and sister company TEI Medical, also Waltham, MA, which focuses on regenerative for wound healing and orthopedics.
Merge Healthcare Incorporated, Chicago, IL, a leading provider of clinical systems, has entered into a strategic partnership with Toshiba America Medical Systems, Inc., Tustin, CA, a global leader in imaging technology. Under this new agreement, Toshiba will combine Merge’s cardiology PACS and hemodynamic monitoring solutions with the Toshiba portfolio of vascular x-ray systems.
In’Tech Medical SAS, Rang-Du-Fliers, France, and Memphis, TN, a developer and contract manufacturer of orthopedic surgical instruments, has acquired Turner Medical Inc., Athens, AL, a manufacturer of medical instruments and implants for spinal, orthopedic, and other medical procedures, which positions In’Tech as the world’s largest provider of surgical instruments to the spine industry.
Vygon Group, Ecouen, France, which designs, manufactures, and markets high-tech, single-use medical devices, announced that it will acquire Perouse Medical, Ivry-le-Temple and Irigny, France, which designs, manufactures, and markets cardiovascular medical devices and long-term vascular access devices.
Foster Polymer Distribution, Putnam, CT, a business unit of Foster Corporation specializing in the distribution of medical polymers and additives, announces their official partnership with Mitsui Chemicals America, Inc., Rye Brook, NY, one of the leading manufacturers in the chemical industry, to distribute TPX™ polymethylpentene olefin copolymer to the North American medical market. This olefin is suited for mandrels used in the manufacturing precision medical tubing and release films for shipping and handling applications.
Miscellaneous
Mouser Electronics, Inc., Mansfield, TX, announced the introduction of its updated Internet of Things Applications site . Mouser's updated and enhanced IoT Applications site brings together the two evolving technologies critical for IoT: wireless connectivity for interconnecting embedded systems, and smart sensors.
Sorin S.p.A., Milan, Italy, which signed a merger agreement with Cyberonics, Inc., Houston, TX, will operate under a new name, LivaNova, which will operate as three separate business units encompassing cardiac surgery, cardiac rhythm management, and neuromodulation, with headquarters for the divisions in Mirandola, Italy, Clamart, France, and Houston, TX, the company said.
The Universal Biotech Innovation Prize 2015 has announced the semi-finalists. US-based finalists include Procyrion, Inc., Houston, TX; LumaMed LLC, Johns Creek, GA; Woven Orthopedic Technologies, Manchester, CT; and Vault Nano, Inc., Beverly Hills, CA. The two winners of the Innovation Prize will be announced in October. The Prize is organized by Universal Biotech, a division of Universal Medica Group.
Molded Devices Inc., Riversiude, CA, announces the launch of its innovative online platform offering OEMs, product engineers, designers, and developers a single source portal through which to obtain quotes for new product development, part/product design, and engineering services: www.EngineeringRFQ.com .
National Thermal Engineering Day will celebrated on July 24, 2015. Since July 24 is typically one of the hottest days in the northern hemisphere, National Thermal Engineering Day recognizes thermal engineers and their work keeping devices working properly all over the world.
KOA Speer Electronics, Inc., Bradford, PA, a leading supplier of passive electronic components, announced the company has received TTI's 2014 Platinum, Diamond and Best Quality Awards for Supplier Excellence. TTI, Inc., Fort Worth, TX, a Berkshire Hathaway company, is an authorized, specialty distributor of interconnect, passive, and electromechanical components.
The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System, Washington, DC, is now accepting proposals for its “Make Your Medical Device Pitch for Kids!” competition. Two top prizes of $50,000 each will be awarded to the winning presentations at the Third Annual Pediatric Surgical Innovation Symposium in October. For competition details, click here .
Morgan Advanced Materials, Windsor, UK, a global materials engineering company, announced that it now has the capability to manufacture defect-free lead zirconate titanate ceramic products in wall thicknesses as low as 50 µm, which are suited to high-precision applications such as high-frequency ultrasound systems.
Isola Group, Chandler, AZ, a market leader in copper-clad laminates and dielectric prepreg materials used to fabricate advanced multilayer Printed Circuit Boards, and Semico Research, Phoenix, AZ, a semiconductor marketing and consulting research company, announced that they have teamed up to launch Boards, Chips and Packaging: Designing to Maximize Results, a new industry event to address the roles of system architecture, board design, chip design, package design and final fabrication and assembly processes for hardware product development. To learn more, visit http://www.semico.com/events .
