Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
UL (Underwriters Laboratories), Northbrook, IL, announced that the FDA has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells).
Teleflex Incorporated, Wayne, PA, a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its ARROW-Clark™ VectorFlow™ Chronic Hemodialysis Catheter. Teleflex also announced that its subsidiary Hotspur Technologies, Inc. received FDA 510(k) clearance to market its Arrow® GPSCath® Balloon Dilatation Catheters.
Biomet Sports Medicine, LLC, Warsaw, IN, a subsidiary of Biomet, Inc., announced the launch of its JuggerKnotless Soft Anchor device, part of a family of all-suture implants.
Advanced Bionics, Valencia, CA, a global leader in cochlear implant technology, has received approval by the China State Food and Drug Administration for its Neptune™ sound processor, the world’s first and only swimmable, waterproof cochlear implant sound processor, in China.
Titan Spine LLC, Mequon, WI, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, announced that it has received clearance from the FDA to commercially release its Endoskeleton® TL system, a spinal fusion system utilizing a lateral approach.
Boston Scientific Corporation, Natick, MA, has received the CE Mark for the Ranger™ Paclitaxel-Coated PTA Balloon Catheter. The technology is now in full European market launch. The company also received the CE Mark and has begun the European commercial launch of its new 25 mm Lotus™ Transcatheter Aortic Valve Implantation System, complementing the currently available 23 mm and 27 mm valve sizes.
Teleflex, Inc., Wayne, PA, leading global provider of medical devices for critical care and surgery, has received FDA 510(k) approval to market its Arrow-Clark VectorFlow chronic hemodialysis catheter in the US. In addition, Teleflex announced the European launch of its CE-marked LMA SureSeal™ PreCurved.
Utitec, Inc., Watertown, CT, announced that its Quality Management System has been certified to both the ISO 9001:2008, and the ISO 13485:2003 international quality management system standards. In addition, Utitec announced that it has Heat Treating added on to the scope of both Quality System certifications.
Sterigenics International LLC, Deerfield, IL, a global provider of outsourced contract sterilization services, has received ISO/IEC 17025:2005 food and chemistry accreditation in Mexico, signifying that the SteriPro laboratory is competent to carry out the necessary microbiological and chemical tests necessary to meet the needs of its medical device and food customers.
Sparta Systems, Inc., Hamilton, NJ, a global leader in enterprise quality management solutions (EQMS), has launched its newest version of its EQMS software, TrackWise®, providing access to new tools and services such as the TrackWise Mobile Product Suite, TrackWise Analytics, and Stratas™, a cloud-based supplier quality management solution.
Factory CRO, Bilthoven, The Netherlands, a leading medical device clinical research organization, announced a new early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators. See www.factory-cro.com .
QNX Software Systems Limited, Ottawa, Ontario, Canada, a subsidiary of BlackBerry, a provider of highly reliable software platforms for safety-critical environments, launched a new release of its OS for medical devices. The QNX® OS for Medical 1.1 complies with the IEC 62304 medical device standard for software life cycle processes and is designed to help manufacturers reduce the cost of developing robotic surgical instruments, patient monitoring systems, infusion pumps, blood analysis systems, and other safety-critical products that must pass stringent regulatory approval.
IBA (Ion Beam Applications SA), Louvain-la-Neuve, Belgium, the world’s leading provider of proton therapy solutions to treat cancer, has received FDA 510(k) approval for its Compact Gantry Beam Line, which may increase international interest in its Proteus®ONE*, IBA’s next generation proton therapy compact system.
Syncardia, Tucson, AZ, announced that The Freedom® portable driver received FDA approval for use with the SynCardia temporary Total Artificial Heart as a bridge to transplantation in cardiac transplant candidates who are clinically stable.
Blue Belt Technologies, Inc., Minneapolis, MN, has received FDA 510(k) clearance to market their latest surgical application for its Navio® Surgical System, patellofemoral joint replacement surgery.
Varian Medical Systems, Palo Alto, CA, has received FDA 510(k) clearance for its Calypso® soft tissue Beacon® transponder to enhance the precision of radiotherapy and radiosurgery treatments for cancer.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval and first use of the FlexAbility™ Ablation Catheter, a novel ablation technology used to treat cardiac arrhythmias.
United Performance Metals' Houston, TX, facility has been audited in accordance with the requirements of AS 9104-1 by ISOQAR and conforms to the Quality Management System Standards ISO 9001: 2008 incorporating the requirements of AS9100-C. The Quality Management System is applicable to: supply, process, stock, and distribute stainless steel and high temperature alloy plate.
Royal Philips, Andover, MA, has received FDA 510(k) clearance to market its innovative ultra-mobile ultrasound system, VISIQ, in the US.
Insight, Tempe, AZ, a leading worldwide technology provider of hardware, software, and service solutions in healthcare environments across the US, announced the launch of Insight ON: Healthcare, a news and digital information resource created to help the healthcare community navigate myriad IT challenges.
Leadership News
Covidien plc, Dublin, Ireland, announced that Bryan Hanson, who currently serves as group president, Medical Devices & US, will be elevated to the newly created position of group president, Covidien, effective Oct. 1.
Intact Vascular, Inc., Wayne, PA, a developer of medical devices for minimally invasive peripheral vascular procedures, announced that Bruce J. Shook is joining the company as President and Chief Executive Officer and as a member of its Board of Directors.
InspireMD, Inc., Boston, MA, a leader in embolic protection systems, announced the appointment of James Barry, PhD, as Chief Operating Officer. He will be based in the company’s Boston headquarters.
TearLab Corporation, San Diego, CA, announced the appointment of Manoj S. Venkiteshwar, PhD, to the newly created position of Vice President of Medical Affairs.
Milacron LLC, Cincinnati, OH, a global leader in high-precision plastic processing technologies and control systems, announced that John J. Gallagher III has joined Milacron as Chief Operations Officer - Melt Delivery & Control Systems/Fluid Technologies/Finance and Shared Services. In this newly created role John will be responsible for Mold-Masters, DME, Cimcool, and several internal Milacron services.
iSTAR Medical SA, Isnes, Belgium, an ophthalmic device company, announced that Michel Vanbrabant has been appointed Chief Executive Officer and a member of its Board of Directors.
MicroCHIPS, Inc., Waltham, MA, a developer of implantable drug delivery devices, today announced that its Board of Directors has appointed Cheryl R. Blanchard, PhD, as Chief Executive Officer and member of the Board of Directors effective immediately.
Oncologix Tech Inc., Alexandria, LA, a medical holding company has appointed Harold Halman to serve as the President/COO of its newly formed Medical Products and Technology Division.
Zynex, Inc., Lone Tree, CO, which specializes in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, and neurological diagnostics, announced the appointment of Brian Alleman as its new Chief Financial Officer.
AMETEK, Inc., Berwyn, PA, announced the appointment of Kurtis L. Goos as Vice President and General Manager, Engineered Medical Components, within AMETEK's Engineered Materials, Interconnects and Packaging Division. In addition, its Board of Directors has elected Robert J. Amodei as Vice President, Audit Services.
Expansions/Moves/New Services
Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts, now offers accurate, repeatable, and powerful slide forming machinery, ideal for economical production of intricate springs, stampings, and wire forms. Complex forming operations that add cost to progressive tooling can be formed easily on slide forming machinery. Parts produced using slide forming machinery include welded medical bands, surgical staples, wire formed clamps, retention spring clips, blade locks, clutch springs, and float wires.
Stratasys Asia Pacific, a subsidiary of Stratasys Ltd., a global leader of 3D printing and additive manufacturing solutions, announced the opening of its 3D Printing Experience Centre at its new office located in Toa Payoh, Singapore, providing local support to serve the growing needs in South Asia and Pacific region.
Kinetics Climax Inc., Wilsonville, OR, has launched QuickMIMTM, its new Rapid Prototyping Service, where customers are guaranteed to receive Kinetics Quality Parts utilizing prototype tooling at the fraction of cost and lead time of conventional production MIM (metal injection molding) components.
Polyzen Inc., Apex, NC, a custom, thin-wall manufacturer of components for medical devices, has expanded its clean room operations to include film extrusion in a Class 10,000 environment.
VPT Inc., Blacksburg, VA, a HEICO company, has added VPT Rad℠, a comprehensive radiation laboratory and test services facility in Chelmsford, MA. The facility provides specialized environments and equipment for evaluating electronics used in applications where ionizing radiation can degrade device performance.
EOS GmbH Electro Optical Systems, a technology and market leader in design-driven, integrated e-Manufacturing solutions in the field of Additive Manufacturing, has moved into its new 17,000 sq. ft. Technology and Customer Center in the Krailling Innovation Mile, Krailling, Germany.
United Performance Metals, Hamilton, OH, a leading supplier of stainless steel, duplex stainless steel, nickel alloys, and cobalt alloys, has increased its inventory of nickel plate product and added processing capabilities that include a plate shear and a high definition plasma table in its Houston, TX, facility.
Isola Group S.à r.l., Chandler, AZ, a market leader in copper-clad laminates and dielectric prepreg materials used to fabricate advanced multilayer printed circuit boards, announced a conversion service for PCB fabricators of radio frequency and millimeter-wave applications. Its global 24-hour design review service will enable PCB fabricators to quickly and cost-effectively transition their current RF substrates to Isola’s RF products. Isola also announced a free Impedance and Power-Handling Calculator to predict design attributes for microstrips and striplines based on the design’s target impedance and dielectric properties of the company’s RF, microwave, and millimeter-wave laminate materials. See https://isodesign.isola-group.com/phi-calculator .
Memry Corporation, Bethel, CT, a leader in Nitinol manufacturing, is expanding its headquarters by 15,000 sq. ft. to enhance its precision manufacturing of Nitinol components for the medical device industry.
Intelligrated, Cincinnati, OH, a leading automated material handling solutions provider, has opened an expanded district office in New Brighton, MN, part of the company’s Midwest regional operations.
Millstone Medical Outsourcing, Fall River, MA, announced that it will add 40,000 square feet in an expansion of its headquarters, which will double production capacity at the medical device sterilization and packaging plant.
Mergers/Acquisitions/Collaborations/Licensing
Royal Philips, Amsterdam, The Netherlands, announced that it has signed an agreement to acquire Unisensor, Belgium, an innovator in the field of optical analysis of fluids for diagnostic applications in health care.
LEMO, Ecublens, Switzerland, a global leader in the design and manufacture of precision custom connectors, has acquired Northwire, Inc., Osceola, WI, a specialty cable manufacturer of wire and multi-conductor cable and retractiles for the medical, aerospace and defense, energy, and industrial markets.
ATS Labs, Inc., Eagan, MN, has acquired the assets of MicroTest Labs, Inc., Agawam, MA. The combined companies will soon be known as Accuratus Lab Services as it continues to support the antimicrobial, consumer product, medical device, and biopharmaceutical industries.
Parker-Hannifin Corporation, Cleveland, OH, a leading motion and control technologies provider,announced that it has teamed up with the Cleveland Clinic to develop more than 100 technologically complex medical devices.
Cardinal Components, Inc., Wayne, NJ, a world leader in the manufacturing of programmable oscillators, solid state batteries, and IOT module-based electronics solutions, has entered into a distributor agreement with Jameco Electronics, Belmont, CA, a leading electronic components distributor.
TVS (Test and Verification Solutions Ltd), Bristol, UK, a leader in software test and hardware verification solutions, has established a unit software testing strategy for Creo Medical, Chepstow, South Wales, a manufacturer of clinically innovative medical devices. The work by TVS enabled Creo Medical to proceed with the certification process of its CROMA system software to the medical device software safety standard IEC 62304.
Novartis, Zurich, Switzerland, has agreed to develop “smart” contact lenses designed by Google, Mountain View, CA, to help diabetics track their blood glucose levels. Under the deal, the Alcon eyecare unit of Novartis will further develop and commercialize the lens technologies designed by Google.
Skanray Technologies Pvt. Ltd., Mysore, India, a medical equipment manufacturing firm involved in radiology, critical care, patient monitoring, primary healthcare solutions, and telemedicine, has acquired CEI-Italy (Compagnia Elettronica Italiana), Bologna, Italy, an X-ray tube manufacturer that will manufacture medical devices for Skanray’s EU and North America OEM market.
NelipakCorporation, Cranston, RI, announced that it has acquired Debond Corporation/Flexpak Corporation, Phoenix, AZ, which will operate under the name of NelipakHealthcare Packaging.
SunTech Medical, a global leader in clinical-grade, non-invasive blood pressure measurement solutions, has acquired King’s College London’s central blood pressure technology as well as the assets of Centron Diagnostics Ltd., London, UK, including its clinically-validated cBP301 Central Blood Pressure Monitor.
Miscellaneous
igus®, East Providence, RI, announces its new guarantee program for continuous-flexing cables. The new “Chainflex Guarantee Program,” has three levels: orange, silver, and gold. Orange membership entitles users to 18 months, or 5 million double-strokes; Silver level guarantees 24 months or 7.5 million double-stokes; and gold membership gives 36 months or 10 million double-strokes of guaranteed operation. The guarantee program requires that the Chainflex cables operate within the predefined operating conditions for the cable’s respective series.
The Fogarty Institute for Innovation, Mountain View, CA, an educational non-profit that mentors, trains, and inspires the next generation of medical innovators, has announced that this year's recipient of the Lefteroff Innovator Award, which directly funds projects for promising new innovators working on pre-screened medical ideas, was presented to InPress Technologies, San Luis Obispo, CA, which is developing a device to treat postpartum hemorrhage.
YTI, Inc., Ashford, CT, is celebrating the company’s 30-year corporate anniversary providing field service on vacuum coating equipment for the optical and semiconductor industries, as well as customization of existing vacuum systems and construction of new systems.
VadaTech, Henderson, NV, a manufacturer of embedded boards, chassis, and complete application-ready platforms, is celebrating its 10th anniversary today. The company recently invested in a $25 million state-of-the-art facility, tripling the number of production lines.
