Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals
Teleflex Inc., Limerick, PA, a global provider of medical devices for critical care and surgery, announced that its ARROW® VPS G4™ Device, a next generation vascular positioning system, has received 510(k) market clearance from the FDA and will be available in the US in Q2, 2013.
NinePoint Medical, Inc., Cambrdge, MA, an emerging leader in the development of medical devices for in vivo imaging, has received an additional 510(k) clearance from the FDA for its NvisionVLE™ Imaging System, expanding the system’s indication to include imaging of esophageal tissue microstructure.
InterValve, Inc., Minneapolis, MN, an early stage medical device company, has received 510(k) clearance to market the new V8™ Aortic Valvuloplasty Balloon Catheter in the US. It is designed to be used in stand-alone balloon aortic valvuloplasty, and pre-dilation during transcatheter aortic valve replacement procedures.
St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval and the European launch of its Allure Quadra™Cardiac Resynchronization Therapy Pacemaker, bringing the quadripolar lead technology to the pacemaker market for the first time. In addition, St. Jude announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Blockade Medical LLC, Irvine, CA, a privately held company focused on the development of catheter based therapeutic devices for the treatment of cerebral aneurysms, announced that the Barricade Coil SystemTM has received 510(k) Clearance from the FDA and that the first series of clinical cases treated with the Barricade Coil System in the US has been successfully completed.
Spine Wave, Inc., Shelton, CT, a privately held medical device company committed to develop and deliver devices to treat spinal disorders, has received 510(k) clearance from the FDA to market and sell the StaXx® IB System, an intervertebral body fusion device.
NovoSource, Dayton, OH, a developer and manufacturer of orthopedic implant systems, has received FDA clearance for its NovoKnee knee replacement product, used in performing total joint replacement procedures for the knee.
NxStage Medical, Inc., Lawrence, MA, a manufacturer of innovative dialysis products, announced that the FDA has cleared new high flow capabilities with the NxStage System One™, the only portable hemodialysis system cleared for home use, and expects to offer the system in the US later this year.
ETView, Tel Aviv, Israel, announced that the company has received clearance of a 510(k) Pre-Marketing Notification Application with the FDA expanding the available sizes of the VivaSight™-DL Airway Management System, a proprietary, single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system to permit airway control and lung isolation during certain surgical procedures.
BiO2 Medical, Inc., San Antonio, TX, is among the first to receive FDA approval of its Investigational Device Exemption (IDE) application to begin an Early Feasibility Pilot Study using the Angel™ Catheter, the first to combine the functions of an Inferior Vena Cava Filter and a multi-lumen Central Venous Catheter to prevent pulmonary embolisms, and for access to the central venous system.
Celestica Inc., Toronto, Ontario, Canada, a global leader in the delivery of end-to-end product lifecycle solutions, is pleased to announce that its Oradea, Romania facility is now certified to ISO13485.
Masimo , Irvine, CA, announced that its rainbow® Acoustic Monitoring™ sensor, RAS-125c Acoustic Respiration Cloth Sensor has received FDA 510(k) clearance for continuous, noninvasive monitoring of acoustic respiration rate in pediatric patients. The FDA had previously cleared the device for adult use.
STD Med, Inc., Stoughton, MA, has received a second Certificate of Good Practices for Manufacturing of Class III Medical Devices from ANVISA, the Brazilian National Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria –ANVISA).
Medtronic, Inc., Minneapolis, MN, announced FDA approval and the US launch of its Viva cardiac resynchronization therapy with defibrillation devices and Evera implantable cardioverter-defibrillators. Both devices include SmartShock 2.0 technology, the next generation shock reduction algorithm that enables devices to better differentiate between dangerous and harmless heart rhythms.
IDx LLC, Iowa City, IA, a announced that its first commercial product, IDx-DR software to detect diabetic retinopathy, has received CE approval as a Class IIa medical device. CE marking clears IDx-DR for sale in 31 countries that comprise the European Economic Area.
Hill-Rom Holdings, Inc., Batesville, IN, a global leader in healthcare technologies, has received 510(k) clearance from the FDA to market the MetaNeb® 4.0 System, the company's latest advancement in airway clearance technology for enhanced patient care in the hospital.
Maxim Surgical, Richardson, TX, a new designer and manufacturer of spinal implants, has received 510(k) clearance from the FDA for its new MaxFuse-C™ cervical interbody fusion system made of Zeniva® polyetheretherketone (PEEK) rods from Solvay Specialty Polymers.
Exactech, Inc., Gainesville, FL, which designs and manufactures bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, said that its Exactech Spine division has received FDA clearance of its new Gibralt® Occipital Spine System, which includes occipital plates and 360⁰ articulating rods.
Combat Medical Systems, Fayetteville, N.C., announced that its Combat Ready Clamp, a vise-like tourniquet, received new critical indications from the FDA making it the first device of its kind approved to treat unmanageable amputations and pelvic wounds not addressable with standard limb tourniquets. It was approved for use on all five anatomical junctions where life-threatening hemorrhage can occur in the result of such actions as roadside and terrorist bombings.
Life Spine, Hoffman Estates, IL, a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that the FDA has given 510(k) marketing clearance to its IRIS Anterior Cervical Plate System.
BIOTRONIK, Berlin, Germany and Lake Oswego, OR, a leading manufacturer of cardiovascular medical technology, announced that the FDA granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator series.
X-spine Systems, Inc., Miamisburg, OH, a global leader in the design and manufacture of devices to treat spinal disease, announces a new FDA clearance for its Zygafix™ Facet Fusion System, which allows for fusion and stabilization of the facet joint in patients using a hollow fenestrated titanium compression screw with internal bone graft in order to achieve a solid fusion.
Mauna Kea, Paris, France, received FDA clearance for the AQ-Flex 19 miniprobe to perform optical GI biopsies with endoscopic ultrasound-guided fine needle aspiration procedures.
GE Healthcare, Milwaukee, WI, announced that all of its new CT products meet the Medical Imaging and Technology Alliance (MITA) smart dose standard that raises the bar for CT dose management. The MITA standard is made up of four key CT equipment features that enable optimization of radiation dose delivery without compromising the quality of images necessary for an accurate diagnosis—automatic exposure control, pediatric and adult reference protocols, dose check, and DICOM dose structured reporting.
Signostics Ltd., Thebarton, South Australia, has received 510(k) marketing clearance from the FDA to market its new Signos RT, a second generation portable handheld ultrasound device, to the US, where it will be marketed as the “Sonimage P3” – the brand name of Signostics’ newly appointed global partner Konica Minolta Inc.
Sorin Group, Denver, CO, a global medical company and a leader in the treatment of cardiovascular diseases, has received FDA approval for and is beginning the US launch of its SMARTVIEW™ remote monitoring solution for patients with implanted cardiac rhythm management devices.
Leadership News
Intelligrated, Mason, OH, a leading automated material handling solutions provider, announced the appointment of Bob Wilson to the position of Vice President, International Division, to oversee international sales and operations.
Aptiv Solutions, Reston, VA, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation, and execution, has expanded its medical device research capabilities in Europe. The company has apppointed Bernard Sweeney as Senior Vice President, Medical Devices, and Erdmann Zippel as Senior Director, Clinical Operations, who will be based in Allschwil, Switzerland, and Cologne, Germany, respectively.
Sanuwave Health Inc., Alpharetta, GA, which makes non-invasive, biological response activating devices to repair and regenerate tissue, musculoskeletal, and vascular structures, has named Daniel M. Jorgensen, MD, MPH, MBA as new chief medical officer, where he will oversee the company’s clinical programs.
EXSYS Tool, Inc., San Antonio, FL, a provider of high-precision rotary and fixed tool holder solutions for CNC turning centers, has hired Mike Englebrecht to be its territory manager for California. In this newly created role, he will further enhance the company’s sales and support functions as well as overall market position on the West Coast.
Covidien, Dublin, Ireland, a leading global provider of healthcare products, announced the appointment of Jacqueline Strayer as Senior Vice President, Corporate Communications, based in Mansfiled, MA, where she will be responsible for leading global communications strategies.
Milacron LLC, Cincinnati, OH, a global plastics industry leader, has hired Mark Dixon as Vice President of Global Supply Chain and Sourcing, a new position to align the company’s diverse sourcing teams into an integrated strategic supply chain and sourcing organization.
K2M, Inc., Leesburg, VA, the largest privately held spinal device company in the world, announced the promotion of Gianluca Iasci to the position of Executive Vice President, Global Sales—a newly created position to aid the global alignment K2M’s sales organization. He had previously acted as K2M’s Senior Vice President, International Sales.
Expansions/Moves
Millstone Medical Outsourcing, Fall River, MA, announced that the company will offer customers an expanded medical device distribution service, which includes the ability to distribute directly to patients and to provide wholesale distribution to distributors, hospitals, and sales representatives. Millstone Medical has been securing medical device distribution licensing in all states that require the licensing.
Siemens Healthcare opened a 12,000-square-foot ultrasound systems factory in Plymouth Meeting, PA, to manufacture its Acuson Freestyle ultrasound system, which the company described as first and only ultrasound system to feature wireless transducers.
Piezo-Kinetics Inc., Bellefonte, PA, a leading manufacturer of small and specialty piezoelectric ceramic elements and assemblies, has announced a major expansion of its powder processing and precious metal manufacturing plant, adding 13,000 sq ft for powder processing and increasing the facility’s total manufacturing area to 33,000 sq ft and raises powder production capacity from 2000 lb/month to 20,000 lb/month.
The SARTA 2013 MedStart Progress Report identifies 18 new med tech companies in the Sacramento region and indicates that regional med tech employment including medical software and telehealth companies currently totals 4,961. The 2012 Progress Report indicated that regional med tech employment not including software and telehealth companies was 4,712.
Mergers/Acquisitions/Collaborations
Exotic Electro-Optics, Inc. and LightWorks Optics, Inc. announced that the companies have merged operations and are now operating under the name LightWorks Optical Systems, Inc. A subsidiary of II-VI Incorporated, LightWorks Optical Systems is a leading provider of high precision integrated optical systems and infrared optics, coatings and assemblies. Headquartered in Murrieta, CA, the company will continue to operate from the Murrieta and Tustin facilities.
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd., announced the joint acquisition with Pramerica-Fosun Fund to acquire Alma Lasers Ltd., Caesarea, Israel, an internationally known manufacturer of laser, light-based, radiofrequency and ultrasound products with integrated product portfolios for aesthetic and medical applications.
Sensile Medical AG, Hägendorf, Switzerland, a leader in advanced micro pump technology, has entered into a strategic partnership and supply agreement with scPharmaceuticals LLC, Boston, MA, to develop and manufacture an automated patch pump that delivers a diuretic, furosemide, subcutaneously.
Insulet, Bedford, MA, a leader in tubeless insulin pump technology, has entered into an agreement with Eli Lilly and Company to develop a new version of its OmniPod insulin pump specifically designed to deliver a concentrated form of insulin used by people with highly insulin resistant type 2 diabetes.
Smith & Nephew plc, Hull, UK, a global medical technology business, has entered into an agreement to acquire Adler Mediequip Private Limited, Pune, India, and with it, the brands and assets of Sushrut Surgicals Private Limited, a leader in mid-tier, orthopaedic trauma products for the India market.
NuVasive, Inc., San Diego, CA, focused on developing minimally disruptive surgical products and procedures for the spine, has acquired ANC, LLC, Dayton, OH, a spine implant manufacturer that is currently one of NuVasive's implant suppliers.
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, announced a successful design-validation partnership with Pace, a leading global developer of advanced technologies for service providers, to help gain SCTE-40 certification on various equipment for the cable and broadband industry.
Haldor Advanced Technologies, Cherry Hill, NJ, a leading provider of RFID-enabled surgical item visibility solutions for hospitals and sterilization centers, and Device Technologies, Sydney, Australia, a leading distributor of medical devices, signed a cooperation agreement that will enable the distribution of Haldor’s RFID solutions in Australia and New Zealand.
Agilent Technologies Inc., Santa Clara, CA, a leader in chemical analysis, life sciences, diagnostics, electronics, and communications, is collaborating with Nallatech, Camarillo, CA, a provider of accelerated computing solutions, to develop high-speed signal acquisition and network monitoring systems that address the high-throughput processing and signal diversity requirements of LTE/SAE core and access optical networks.
TriStar Wellness Solutions, Inc., Westport, CT, a health and wellness company, has acquired HemCon Medical Technologies Inc., Portland, OR, a leading researcher and manufacturer of products for bleeding and wound management.
Miscellaneous
Orthocare Innovations, LLC, Oklahoma City, OK, received the top prize in the Science and Medicine–Assistive Device category for its Magellan™ microprocessor foot ankle system prosthetic device from the Edison Awards, which recognize ideas at the forefront of new products, services, marketing, design, and innovation. The Magellan was profiled in the April issue of Medical Design Briefs.
ACell, Inc., Columbia, MD, a leading developer of next-generation regenerative medicine products, has received the Space Medicine and Related Technologies Commercialization Assistance Program (SMARTCAP) award, given by National Space Biomedical Research Institute's (NSBRI) Industry forum. The award will support ACell in the development of innovative new medical devices that address unmet health needs in space and on Earth, specifically in the area of wound care.
SynCardia Systems, Inc., Tucson, AZ, manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart, announced that its Freedom® portable driver, the world’s first wearable power supply for the SynCardia temporary Total Artificial Heart, was named the 2013 Silver Winner amongst Assistive Devices in the Science/Medical category of the Edison Awards on April 25 in Chicago.
Nordson MARCH, a Nordson Company, Concord, CA, a global leader in plasma processing technology, received the EM Asia-China Award for its FlexVIA™ Plasma System, a completely self-contained vacuum plasma system designed for maximum efficiency and cost-effective etch, desmear, and surface activation treatment of flexible printed circuit boards.
Secant Medical, Inc. Perkasie, PA, received the MedTech Leadership Award at the 20th Annual Enterprise Awards from the Greater Philadelphia Alliance for Capital and Technologies on May 9. Secant was selected for its industry vision and leadership, ability to attract and retain talent, and involvement in the local community.
Orthofix International N.V., Lewisville, TX, announced that its Ankle Compression Nailing System has been chosen as a finalist in the 15th annual Medical Device Excellence Awards. Orthofix identified Orchid Design, Holt, MI, as a key supplier in the design of the system and Orchid California as a key supplier in the manufacturing of the system. Winners will be announced at the MD&M East show in Philadelphia next month.
GE Global Research, Niskayuna, NY, the technology development arm of the General Electric Co., is honored to announce that Dr. E. Trifon Laskaris, Chief Engineer and pioneer in imaging technologies, has been awarded his 200th U.S. patent—a milestone previously reached by only one other GE research lab employee, Thomas Edison. His work on superconductivity contributed to the invention of the MRI.
Welch Allyn, Skaneateles, NY, announced that Ervin Goldfain, lead engineer, product development, was selected as the recipient of the 2013 Distinguished Inventor of the Year award presented by the Rochester Intellectual Property Law Association, which recognizes contributions to useful applications of science and technology. Goldfain helped develop the technology in the Welch Allyn MacroView™ Otoscope, PanOptic™ Ophthalmoscope, and SureSight™ Vision Screener.
The U.S. Energy Department is pleased to announce that Dr. Paul D. Jablonski, Metallurgist at the National Energy Technology Laboratory, has been selected as a finalist for the Samuel J. Heyman Service to America Medal from the Partnership for Public Service, recognizing him for his revolutionary development of coronary stent technology. He developed a stent made of a platinum-chromium alloy, making it visible to an x-ray, and also enhancing the stent’s safety and reliability. Stents were previously made only of bare metal, and some are coated with medication to prevent narrowing of the arteries. This medal recognizes a federal employee for a significant contribution to the nation in activities related to science and environment.
Scheugenpflug AG, Neustadt/Donau, Germany, welcomed more than 300 clients and attendees from 20 nations to their Technology Days on April 24-25. The venue of the event was the recently inaugurated new production hall on the company premises. Aside from ten outstanding technical presentations, which were held in English and German in separate panels, the invited industry audience witnessed hands-on demonstrations of the latest product innovations in vacuum technology, resin degassing and process automation in the new 6000 sqm production area.
