Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
True Wearables, Inc., Rancho Santa Margarita, CA, a medical device start-up, has launched Oxxiom, the world's first wireless, continuous, fully disposable, single-use pulse oximeter, which measures arterial oxygen saturation, pulse rate, and perfusion index.
NuCryo Vascular LLC, Sunnyvale, CA, a subsidiary of Gemini Interventional Technologies, LLC, announced that its has received FDA 510(k) clearance on its next-generation reusable Cryoplasty Inflation Device and that NuCryo Vascular LLC will be selling the current and next-generation model via a direct sales team.
Vascular Dynamics, Inc., Mountain View, CA, which is developing novel solutions to treat hypertension, has received CE Mark approval for its MobiusHD™ System, a minimally invasive system to treat resistant hypertension.
Nelson Laboratories, Salt Lake City, UT, a leading provider of microbiological testing and consulting services for medtech companies, announced that it has been inspected and approved by Australia's Therapeutic Goods Administration (TGA), the governing body responsible for regulating therapeutic goods, including medical devices, imported to and manufactured in Australia. The company was also as a 2015 winner of the Governor’s Medal for Excellence in Science and Technology—the only company recognized with this award. Nelson Labs has made generous contributions in support of classroom instruction, resources, and STEM education.
Maquet Medical Systems USA, Wayne, NJ, which designs, develops, and sells innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, has launched two new intensive care ventilators, SERVO-U®, and its dedicated neonatal intensive care solution, SERVO-n®.
SRS Medical Systems, Inc., Billerica, MA, manufacturer of the only prostate stent on the US market, has received an FDA investigational device exemption approval for a safety study to expand the indications for use for its Spanner® Temporary Prostatic Stent.
Waters Corporation, Milford, MA, which designs, manufactures, sells, and services analytical technologies, announced that its ACQUITY UPLC I-Class IVD/Xevo TQ-S micro IVD System is now manufactured as a US FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD).
K2M, Inc., Leesburg, VA, a global medical device company focused on designing, developing, and commercializing complex and minimally invasive spine technologies, has received FDA 510(k) clearance and the CE Mark for its Cascadia lateral interbody system, which uses 3D printing to allow for bony integration throughout an implant.
Vivasure Medical Ltd., Galway, Ireland, has obtained the CE Mark for its percutaneous vascular closure device for large-bore femoral arteriotomies.
Animas Corporation, Chesterbrook, PA, announced that the FDA has approved the use of the Animas® Vibe® Insulin Pump and Continuous Glucose Monitoring System for the management of diabetes in children and adolescents, ages 2 to 17.
OptMed Inc., New York, NY, which is developing an innovative line of surgical, biocompatible adhesives, announced that it has received FDA 510(k) marketing clearance for its BondEase® product, a topical skin adhesive intended to close surgical incisions and lacerations as an alternative to sutures and staples.
Fujifilm VisualSonics, Toronto, Canada, a world leader in ultra high frequency ultrasound imaging systems and subsidiary of FUJIFILM SonoSite, Inc., announces CE Mark for its Vevo®MD, the world’s first ultra high frequency clinical ultrasound system.
Bio2 Technologies, Inc., Woburn, MA, working to commercialize a range of products for orthopedic surgery, has received FDA 510(k) clearance for its Fusion Implant system for interphalangeal fusion, fracture repair ,and osteotomies of the toes, fingers, and other small bones.
Leadership News
Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device, and specialty commercial markets, announced the appointment of Iran Bateman to the position of Vice President, Engineering Europe where he will lead strategy implementation and European pre-production engineering organization.
JenaValve Technology, Inc., Irvine, CA, a next-generation heart-valve technology company, announced the appointment of veteran medical device executive Janet M. Fauls as Vice President of Regulatory Affairs.
MannKind Corporation, Valencia, CA, which focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes, announced the appointment of Matthew J. Pfeffer as its Chief Executive Officer, and member of the Board of Directors. He will continue serving as Chief Financial Officer as well.
Ivenix, Inc., Amesbury, MA, a medical technology company developing a next-generation infusion management platform, announced the appointment of Stuart A. Randle to Chief Executive Officer.
MicroCare Corp., New Britain, CT, a leading manufacturer of environmentally progressive products for precision cleaning, coating, and lubrication, announced that Rick Hoffman has joined the company as the Eastern Regional Sales Manager.
Dictum Health, Inc., Oakland, CA, pioneering next-generation, mobile and cloud-based telehealth solutions, announced today the formation of its executive team. Mory Ejabat is the Founder and CEO; Chief Medical Officer is Chris Simmons, MD; Vice President of Engineering is Kim Hobbs; Vice President of Product Management is Elizabeth Keate; Vice President of Quality and Regulatory Affairs is Paul Landesman, PhD; and Deb Anderson is Vice President of Marketing.
MedLumics, Madrid, Spain, a cardiology device company specializing in advanced optical coherence tomography technology, has announced the appointment of Tim Lenihan to the company’s Board of Directors.
PathMaker Neurosystems Inc., Boston, MA, a clinical-stage neuromodulationcompany developing non-invasive neurotherapy systems to treat patients with neuromotor disorders, has named Deborah DiSanzo, MBA, to the company’s Board of Directors.
Foster Delivery Science, Putnam, CT, a company that specializes in hot melt extrusion, has hired Robert Diehl as Director of Quality and Regulatory Compliance.
Expansions/Spinoffs/New Services/Moves
Sterigenics International, Deerfield, IL, a leading global provider of contract sterilization, gamma technologies, and medical isotopes, announced expansion at its Forth Worth, TX, facility with the addition of a new gamma cell that will increase capacity by 30%. Expansion will be complete by Q2 2017. In the past year, the company has tripledsterilization capacity at its location in West Memphis, AR; significantly expanded its irradiation facility in Gurnee, IL;and increased its global service capabilities with the acquisition of leading Latin American sterilization firm Companhia Brasileira de Esterilização (CBE).
Freudenberg Medical, Carpinteria, CA, a global developer and manufacturer of specialty components and minimally invasive solutions for the medical device and pharmaceutical industry, announces the expansion and enhancement of its extrusion and molding cleanrooms at the company’s silicone operations in Carpinteria. The project includes floor expansion, updated layout, and optimized workcells, along with state-of-the-art cleanroom infrastructuretechnology. Its extrusion cleanroom now complies with ISO Class 7 guidelines.
Mergers/Acquisitions/Collaborations/Licensing
Precision Coating Co., Inc., Boston, MA, which serves global health care and medical device companies, coating medical devices such as guide wires, core wires, hypotubes, and forming mandrels, has acquired Boyd Coatings Research Co., Inc., Hudson, MA, a provider of coating application services. Together they will provide extensive and complementary fluoropolymer application services to the medical device and highly engineered components markets.
Pexco LLC, Alpharetta, GA, a leading specialty plastics manufacturer across the medical, defense, and industrial markets, has acquired Scientific Plastics Corporation, St. Paul, MN, a dual-certified ISO 9001 and ISO 13485 manufacturer of injection-molded plastics with extensive experience processing demanding engineering materials such as PEEK, Ultem®, polysulfone, polycarbonate, and others.
Teleflex Incorporated, Wayne, PA, a leading global provider of medical devices for critical care and surgery, has acquired Nostix, LLC, Boulder, CO, a developer of innovative tip confirmation systems that are used to increase the accuracy of vascular access device placement.
Allied Motion Technologies Inc., Amherst, NY, a global designer and manufacturer of motion control products, has signed an agreement to acquire 100% of the stock of Heidrive GmbH, Kelheim, Germany, which designs and manufactures customized innovative synchronous motion systems for highly demanding applications.
CONMED Corporation, Utica, NY, which provides surgical devices and equipment for minimally invasive procedures, has completed its previously announced acquisition of privately-held SurgiQuest, Inc., Milford, CT, which will become part of the CONMED Advanced Surgical business. SurgiQuest develops, manufactures, and markets the AirSeal® System, the first integrated access management technology for use in laparoscopic and robotic procedures.
Theragenics Corporation, Buford, GA, a medical device company serving the cancer treatment and surgical product markets, has acquired the US and Canadian seed business of Eckert & Ziegler BEBIG, s.a., Oxford, CT. a European-based group whose core business is the production and distribution of medical products for the treatment of cancer using brachytherapy.
Argon Medical Devices, Inc., Plano, TX, which manufactures medical products and devices for interventional radiology, vascular surgery, interventional cardiology, critical care, and oncology procedures, announced the completed acquisition of three vascular products from Rex Medical, LLC, Conshohocken, PA. The OptionELITE Retrievable Vena Cava Filter, CLEANER Rotational Thrombectomy System, and UltraStream Chronic Hemodialysis Catheter are now wholly owned by Argon Medical Devices, Inc.
Panasonic Healthcare Holdings Co., Ltd., Tokyo, Japan, involved in the development, manufacture, and sale of healthcare devices and services, has closed its buy of the diabetes care business of Bayer AG, Leverkusen, Germany, a global enterprise with core competencies in the life science fields. The diabetes care business will operate as a stand alone company, named Ascensia Diabetes Care and will develop, manufacture, market, and sell blood glucose monitoring meters and strips across 125 countries.
COMSOL, Burlington, MA, a global provider of simulation software for product design and research, announces the availability of COMSOL Multiphysics software on Rescale™ simulation platforms. Rescale, San Francisco, CA, is a leading cloud platform provider of simulation software and high performance computing solutions.
NuVasive Inc., San Diego, CA, a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, has agreed to acquire Ellipse Technologies, Inc., Aliso Viejo, CA, a medical technology company focused on procedural solutions for complex skeletal deformity. The transaction is expected to close by the end of February 2016.
Smith & Nephew plc, London, UK, a global medical technologies company, has completed its acquisition of Blue Belt Holdings, Plymouth, MN, which specializes in the field of orthopedic robotics-assisted surgery.
Graham Engineering Corp., York, PA, a global provider of wheel and industrial extrusion blow molding solutions, andThe Conair Group, Cranberry Township, PA, a leading producer of auxiliary equipment for plastics processing, have agreed on an exchange of equipment that will be used in each company’s extrusion laboratory for development and innovation of technology for medical tubing. Under the agreement, Graham will provide an American Kuhne ULTRA CR extruder to Conair’s laboratory in Pinconning, MI. Conair will supply its latest MedVac™ vacuum sizing/cooling tank, a puller-cutter, and a conveyor to be installed in the new, dedicated medical laboratory in Graham’s headquarters and factory in York, PA.
Nexen Group, Inc., Vadnais Heights, MN, a leading manufacturer of precision motion control solutions, announces new partnership with Industri/Motion, Inc., Schaumburg, IL, an experienced representative of premium manufacturers of power transmission and motion control products. Industri/Motion now provides expert coverage of all Nexen products in Chicago and northern Illinois.
Medtronic plc, Dublin, Ireland, a global leader in medical technology, has formed a partnership with the Chengdu, China, municipal government to manufacture and deploy advanced diabetes therapies. As part of the agreement, Medtronic will invest in a manufacturing facility for a next-generation sensor augmented insulin pump system for the growing diabetes population in China. In addition, Medtronic will partner with local government to enable people with diabetes in Chengdu and the broader Sichuan province to access this locally produced technology with software displayed in Chinese language.
SurModics, Inc., Eden Prairie, MN, a leading provider of advanced surface modification technologies for medical devices, has acquired NorMedix, Inc., Plymouth, MN, a design and development company focused on ultra thin-walled, minimally invasive catheter technologies.
Miscellaneous
MELA Sciences, Horsham PA, which designs and develops software-driven medical technologies to detect skin cancer, announced a new corporate name change to STRATA Skin Sciences.
The Arthur G. Russell Company, Inc. (AGR), Bristol, CT, a leading provider of automatic assembly solutions, is again sponsoring Team 3461, Operation P.E.A.C.C.E. Robotics. AGR is providing funds, materials, and mentors who will help design and build a robot for the 2016 FIRST® Robotics Competition – FIRST StrongholdSM. Operation P.E.A.C.C.E. Robotics includes high school students from Bristol and the surrounding communities.
NK Technologies, San Jose, CA, has released its 2016 Product Catalog featuring several new products developed over the past year, including new sensors with a unique patent-pending design. The catalog contains complete specifications, features, and ordering information for: current sensing switches, current and voltage transducers, current transformers, signal converters and power sensing products. The catalog is available in both a printed and electronic PDF version .
MTD Micro Molding, Charlton, MA, a leader in the development of micro-sized injection molded plastic components, has been named a finalist for the Processor of the Year Award from Plastics News.
Nissei ASB Company, a leading maker of stretch blow molding equipment, has moved into a custom facility in Smyrna, GA. Its ASB Technical Support Center when fully operational, will provide product design, development, engineering, manufacturing, training, and customer support.
The Optical Society (OSA), Washington, DC, which provides quality research, inspired interactions and dedicated resources for its extensive global network of optics and photonics experts, is celebrating its 100th anniversary in 2016.
