Here is the latest batch of news from the medical products community. Please click the link for more.

Regulatory Approval

Medtronic, Inc., Minneapolis, MN, has received the CE Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures.

Reverse Medical Corporation, Irvine, CA, announced that the company has been granted CE Mark approval and begun initial clinical use of their MVP™ Micro Vascular Plug system for peripheral artery embolization.

Devon Medical, Inc., King of Prussia, PA, a global medical device manufacturer, designer, and distributor, has received the CE mark for its portable extriCARE(R) 2400 Negative Pressure Wound Therapy (NPWT) system. The CE mark designation will allow the extriCARE(R) NPWT system to be sold in the European Union and other countries that recognize or require this approval.

St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced CE Mark approval of its ILUMIENOPTIS PCI Optimization System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease.

Tryton Medical, Inc., Durham, NC, a leading developer of stents, announced that it has received the CE Mark for the Tryton Side Branch SHORT Stent, a novel coronary stent system that broadens the treatment options in bifurcations in large vessels with a short main branch landing zone. The company is launching the product immediately in CE Mark countries.

Elixir Medical Corporation, Sunnyvale, CA has received CE Mark approval for its DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System, which is designed to degrade in about one year.

Telcare, Bethesda, MD, received CE Mark approval from the European Union for its wireless blood glucose meter, dubbed mHealth. This CE Mark represents the first entry of a wireless blood glucose meter into the European market.

Thoratec Corporation, Pleasanton, CA, a leader in device-based mechanical circulatory support therapies, has received FDA approval to market the HeartMate II® Pocket Controller™, the small, smart, safe face of the HeartMate II LVAD System.

Direct Flow Medical, Inc., Santa Rosa, CA, a transcatheter heart valve company focused on improving patient outcomes, has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System.

Xiphos™ ALIF, a VESTAKEEP® PEEK-based spinal implant developed by DiFusion Technologies, Georgetown, TX, has received FDA 510(k) approval for use in Interbody Fusion Devices.

Covidien, Boulder, CO, a global provider of healthcare products and innovator in patient monitoring and respiratory care devices, announced that its Nellcor™ pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received FDA 510(k) clearance for motion claims, making Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61.

DocCom, Bristol, UK, provider of the first cloud-based enterprise social networking platform exclusively for healthcare, has achieved the ISO 27001 standard for its suite of hospital collaboration products, ensuring that clinicians are guaranteed the highest possible information security management standards for any personal, clinical, and operational information shared within the DocCom network.

Boston Scientific Corporation, Natick, MA, has received CE Mark approval for use of the GUIDE™ DBS System, the world's first deep brain stimulation visualization system, which provides clinicians with 3D visualization information that simulates stimulation output.

Teleflex Inc., Limerick, PA, a leading global provider of medical devices for critical care and surgery, has announced that its subsidiary Hotspur Technologies, Inc., Mountain View, CA, which Teleflex acquired in June 2012, completed CE marking requirements to market the company’s Arrow® GPSCath® Balloon Dilatation Catheters to the European Union. These novel products enable multiple vascular procedures to be performed with one dual-function catheter.

iTraumaCare, San Antonio, TX, an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has received 510(k) clearance from the FDA to market its first product, the iTClampTM Hemorrhage Control System, in the US.

Aptus Endosystems, Inc., Sunnyvale, CA, has received 510(k) clearance from the FDA for its 28mm Tip Reach Heli-FX™ Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms.

Breathe Technologies, Inc., Irvine, CA, a manufacturer of innovative medical devices for people with respiratory conditions, announced that the FDA has granted the company 510(k) clearance to market its Sleep System (continuous positive airway pressure) in the US to treat obstructive sleep apnea.

Advanced Bionics, Valencia, CA, a global leader in cochlear implant technology and a company of the Sonova Group, has received approval from the FDA for its HiFocus™ Mid-Scala electrode and will soon begin shipping in the US. Earlier this year, TÜV and Health Canada approved distributing the new electrode in Europe and Canada.

Leadership News

URAC, Washington, DC, an independent, nonprofit organization that promotes health care quality through its accreditation, education and measurement programs, has appointed Kylanne Green, as President and Chief Executive Officer. She will take the organization’s helm officially on July 22.

Precision Engineered Products LLC, Attleboro, MA, announced the appointment of John Manzi to the position of President and Chief Operating Officer. Precision Engineered Products delivers medical and surgical devices, precision stampings, micro moldings and surface finishing solutions through ten manufacturing locations in the US, Mexico, Dominican Republic, and China.

InnoMed Technologies, Inc., Coconut Creek, FL, a medical equipment manufacturer that develops interface products for use in hospitals, institutions and homecare settings, announced today the appointment of Ron F. Richard to the position of CEO. He will also oversee the sister companies of Mergenet Medical, which is gearing up to launch a HI-FLO therapy device, and Respcare, Inc.

Noxilizer, Inc., Baltimore, MD, the company specializing in room temperature NO2-based sterilization technology for life science manufacturers and hospitals, announced the appointment of David Chaskin as CFO, who will be responsible for all aspects of the company's finance and accounting. In addition, the company recently relocated to a 16,000 square foot office and laboratory space at the University of Maryland BioPark.

Cerapedics, Inc., Westminster, CO, a medical device company focused on developing and commercializing novel osteobiologic products based upon its proprietary synthetic small peptide technology platform, announced that its Board of Directors has appointed Glen A. Kashuba as the company’s new chief executive officer, effective June 1, 2013.

ConforMIS, Inc., Bedford, MA, a medical device company pioneering patient-specific orthopedic implants, has appointed orthopedic industry veteran Matthew Scott as the company’s Senior Vice President of Operations.

Toshiba America Medical Systems, Inc., Tustin, CA, named Beverly Plost as Director, MR Business Unit. She will be responsible for implementing strategic marketing plans and will interface with Toshiba’s global business unit at Toshiba Medical Systems Corporation in Japan to communicate the needs and requirements of the US market.

Wright Medical Group, Inc., Arlington, TN, a global orthopedic medical device company, announced that its shareholders have elected Douglas G. Watson as the tenth member of its Board of Directors.

IPG Photonics Corporation, Oxford, MA, a world leader in high-power fiber lasers and amplifiers, has appointed Dave Krattley to IPG’s Industrial Sales Team, responsible for selling IPG's complete line of materials processing fiber lasers.

BioHealth Innovation, Inc., Rockville, MD, a regional private-public partnership focusing on commercializing market-relevant biohealth innovations and increasing access to early-stage funding, named Ram Aiyar, PhD, MBA, CCO at FlowMetric, Inc., a provider of flow cytometry and cell sorting services, as its first Entrepreneur-in-Residence at the National Institutes of Health’s National Heart, Lung, and Blood Institute, where he will help advance research into new therapeutics, diagnostics, and devices.

Expansions/Moves

ECA Medical Instruments has opened a new company headquarters in Thousand Oaks, CA, that also includes a new design center of excellence. The 24,000 sq. ft. facility will help meet the demand from CRM, neuro, cardiovascular, and orthopaedic OEM customers to design and manufacture single-procedure instruments and procedural kits.

Mergers/Acquisitions/Collaborations

PENTAX Medical, Montvale, NJ, a healthcare industry leader in endoscopic imaging, and Hitachi-Aloka Medical, Wallingford, CT, a global leader in ultrasound imaging, recently announced renewed collaborative efforts between the two global companies to enable further innovation in the development of Endoscopic Ultrasound Systems (EUS). For years, the Hitachi-Aloka ultrasound systems and PENTAX Medical endoscopic portfolio have formed one of the world's most trusted families of EUS systems. This agreement will continue to grow their long-standing alliance.

Fines Tubes, Plymouth, UK, a leading manufacturers of metal tubing, is now working in partnership with Superior Tube, Collegeville, PA. Through Superior Tube, Fine Tubes can now also serve the US market.

Miscellaneous

Nordson ASYMTEK, a Nordson Company, Carlsbad, CA, a leader in dispensing, coating, and jetting technologies, earned two prestigious awards for innovative technology during NEPCON China 2013. The Innovation Award from Electronics Manufacturing (EM) Asia and the VISION Award from SMT China magazines were presented to Nordson ASYMTEK for product excellence in the dispensing category for its NexJet® System.

igus, East Providence, RI, a leading developer of high-performance polymer machine components, won two awards as part of this year's iF product design competition. A panel made up of 50 judges from around the world judged that the company’s e-spool—a variation on traditional cable drums—exceeded its exacting standards. The innovative design guides cables and hoses telescopically and is ideal for restricted spaces. The iF design awards receives more than 20,000 entries from more than 50 countries and are among the largest and most important international design competitions.

Connecticut Spring & Stamping, Farmington, CT, a manufacturer of precision parts for the medical, aerospace, firearms, and defense industries worldwide, announces that it is on schedule to be certified in 2013 to the ISO 13485 standard for quality management for design and manufacturing of medical devices.

Philips North America, Andover, MA, has been named one of the “Best Places to Work for Recent Grads” by Experience, a ConnectEDU company. Philips was named to the list out of a field of 300 companies because it excels at fulfilling the priorities recent graduates name when selecting a place to work.

SynCardia Systems, Inc., Tucson, AZ, manufacturer of the world’s first and only FDA, Health Canada, and CE approved Total Artificial Heart, announced that world-renowned heart surgeon and SynCardia co-founder Jack G. Copeland, MD, was awarded the prestigious Pioneer in Transplantation Award at the annual meeting of the International Society of Heart & Lung Transplantation on April 25 in Montreal.

The Epilepsy Foundation announced that Utkan Demirci, PhD, and Steven C. Schachter, MD, who designed a novel point of care disposable microfluidic chip that can immediately detect the levels of antiepileptic drugs based on a finger-prick sample of blood, were the 2013 winners of the Epilepsy Therapy Project Second Annual “Shark Tank” competition for the most innovative new product idea for people with epilepsy. The microfluidic technology was pioneered by Demirci, Assistant Professor of Medicine, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology. Winners received a $100,000 grant to accelerate this product to the next phase of development and closer to benefitting patients. The Shark Tank competition took place during the annual Antiepileptic Drug and Device Trials (AED) XII Conference in Miami.

In recognition of the expansions of its North American Headquarters campus in Florence, KY, Mazak Corporation received the Cincinnati USA Partnership for Economic Development’s Growth Award, presented to companies that attract and retain businesses, jobs and capital investments in the Greater Cincinnati area, as well as continue to grow and expand within the local area.

Warren Haggard, PhD, professor and Herff Chair of Excellence in Biomedical Engineering at the University of Memphis in Memphis, TN, has received the ASTM International Award of Merit from Committee F04 on Medical and Surgical Materials and Devices. He was honored for “outstanding leadership and high productivity in fostering the development and promulgation of surgical implant standards.”

Perfecseal, Oshkosh, WI, a leader in sterilization packaging for medical devices, has joined the Healthcare Plastics Recycling Council, a private technical coalition across the healthcare, recycling, and waste management industries seeking to inspire and enable sustainable, cost-effective recycling solutions for plastic products and materials used in the delivery of healthcare.

The Plastics Academy is now accepting nominations for posthumous induction into the Plastics Hall of Fame—the highest honor bestowed in the plastics industry. SPI: The Plastics Industry Trade Association is cooperating with The Plastics Academy in administering the nominating process. Nominations must be submitted by October 25, 2013.

A new Vibration Measurement Application Note from Lion Precision, St. Paul, MN, helps the reader determine which tool is best for a specific application. It’s available here: http://www.lionprecision.com/tech-library/appnotes/general-0020-vibration-measurement.html