News

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

Regulatory Approval

Medtronic, Inc., Minneapolis, MN, announced the FDA approval of its MiniMed® 530G with Enlite®, a breakthrough, first-generation artificial pancreas system with Threshold Suspend automation for people with diabetes. The system is the first in the US that can automatically stop insulin delivery when sensor glucose values reach a preset level.

W. L. Gore & Associates, Flagstaff, AZ, announced that the FDA has approved the Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This endoprosthesis is the only device to receive FDA approval for this indication.

Apica Cardiovascular, Galway, Ireland, has received CE Mark Approval for its platform Access, Stabilisation, and Closure system that allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart.

Vasomedical, Inc., Westbury, NY, a diversified medical technology company specializing in the design, manufacture, and sale of medical devices for noninvasive cardiology, announced that its Enhanced External Counterpulsation (EECP) Therapy systems has been given a lla Class of Recommendation in the 2013 European Society of Cardiology Guidelines on the Management of Stable Coronary Artery Disease.

Codman Neuro, Raynham, MA, part of DePuy Synthes Companies of Johnson & Johnson, announced the European launch of its next generation clot removal device, REVIVE™ SE Thrombectomy Device, which offers enhanced navigation through the cerebral vasculature and rapid restoration of blood flow to the brain after an ischemic stroke.

DFINE, Inc., San Jose, CA, a fast-growing market leader in the treatment of spinal diseases, has received CE Mark approval for its STAR™ Tumor Ablation System to treat painful metastatic spinal tumors. The company launched the STAR System in Europe this month.

Monarch Medical Technologies, Charlotte, NC, has earned ISO 13485:2003 certification for its quality management system from the independent certifying body, Nemko. The international quality standard certifies Monarch’s ability to offer medical devices and related services that consistently meet applicable customer needs and regulatory requirements.

Moirai Orthopaedics, LLC, Metairie, LA, an orthopaedic implant development company, has received CE mark approval for its new Pyrocarbon Implant Replacement System to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee.

NeoTract, Inc., Pleasanton, CA, has received De Novo approval from the FDA to market the novel UroLift® System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with enlarged prostate.

Neuros Medical, Inc., Cleveland, OH, a medical device company has received FDA Investigational Device Exemption for its implantable generator Altius™, which delivers patented high frequency Electrical Nerve Block™ technology for patients suffering from chronic pain.

SpineGuard, Paris, France, has secured Japanese Ninsho approval for its PediGuard, a handheld surgical product that helps guide proper spine screw placement.

Tyber Medical LLC, Morristown, NJ, a medical device company focused on developing innovative spine and orthopaedic devices for private label opportunities, has received CE Mark approval for TyPEEK, a proprietary titanium plasma sprayed PEEK interbody system.

Crosstrees Medical, Inc., Boulder, CO, has received FDA 510(k) clearance for its Crosstrees® PVA Pod System for Percutaneous Vertebral Augmentation.

Given Imaging Ltd., Yoqneam, Israel, announced that Japan’s Pharmaceuticals and Medical Devices Agency has granted approval for the company’s PillCam SB 3 capsule endoscopy technology system.

Standex-Meder Electronics, Cincinnati, OH, a manufacturer of miniature switches, sensors, and relays, announced that its MK02, MK11, MK21P, MK26, and MK27 series of reed sensors are now rated IP67, which certifies that the sensors are both totally protected against dust and protected against the effects of immersion between 15cm and 1m.

Leadership News

Mazor Robotics Ltd., Caesaria, Israel, the developer of Renaissance™, an innovative surgical guidance system and its complementary products, announced that Christopher Prentice has been promoted to Senior Vice President, America & Global Marketing, Orlando, FL. In this new role, he will oversee sales operations in the Americas as well as global marketing.

Ximedica, Providence, RI, a provider of comprehensive product development services to leading medical device makers and healthcare companies, has promoted Michael Pereira to Senior Vice President of Technology and Operations.

Edinburgh Instruments Ltd., Edinburgh, UK, which produces lasers, analytical spectrometers, and accessories, announces the appointment of Mark Vosloo as CEO. He joins EI from Oxford Instruments.

Bunting® Magnetics Co., Newton, KS, a producer of precision magnetic products announces its recent hires: Sultan Shaaban has been named Design Engineer for Separation Equipment, Isaac Castro, has been named Design Engineer for Material Handling Equipment, Eric Johnson was named Design Engineer for Material Handling Equipment, and Mark McGovern was named Inside Sales Representative for Separation Equipment.

Sherborne Sensors, Wyckoff. NJ, a global leader in the design, development, and manufacture of sensors announced the appointment of Eugene Leedy as its US sales manager.

Accellent Inc., Wilmington, MA, which provides fully integrated outsourced manufacturing and engineering services to the medical device industry, announced the promotion of Jeremy Friedman from Chief Financial Officer to President and Chief Operating Officer for the Cardio and Vascular business. He will remain an Executive Vice President of Accellent.

AliMed Inc., Dedham, MA, a leading manufacturer and provider of healthcare supplies, announced the appointment of Scott C. Lewis to the position of Chief Executive Officer.

Bioness Inc., Valencia, CA, a leading provider of innovative technologies to help people regain mobility and independence, announced that its Board of Directors has named Todd Cushman as the company’s President and CEO in an effort to refine its strategy and reorganize the company’s core operations to better support its strategic growth opportunities.

Expansions/Moves

Medical Murray, North Barrington, IL, a leading medical device development and contract manufacturing company, will host an open house to showcase their new design and development facility located in Charlotte, NC. The open house will be held on October 23 at 3400 International Airport Drive, Charlotte, NC. For event details, email: This email address is being protected from spambots. You need JavaScript enabled to view it..

Agilent Technologies Inc., Santa Clara, CA, announced plans to separate into two publicly traded companies: one in life sciences, diagnostics and applied markets that will retain the Agilent name, and the other that will be comprised of Agilent’s current portfolio of electronic measurement products.

Meggitt PLC, Irvine, CA, is expanding its sensor and electronics manufacturing. Facilities in San Juan Capistrano, CA, and Londonderry, NH, are being consolidated into a 190,000 sq. ft. location in Irvine where Meggitt expects to grow its workforce to nearly 500 over the next five years with an investment of $24 million.

Mergers/Acquisitions/Collaborations

Molex Incorporated, Lisle, IL, a global electronics components company, has signed definitive agreements as a strategic partner and investor in Vasa Applied Technologies Ltd., Or Yehuda, Israel, which developed an innovative, patent-pending technology that allows accurate measurements of fluid flow rates for medical applications. In addition, Molex has completed the acquisition of FCT Electronics Group, Munich, Germany, which specializes in designing and manufacturing custom mixed-layout connectors and cable assemblies.

Machine Solutions Inc., Flagstaff, AZ, providing innovative and effective proprietary mechanical solutions to a variety of complex process, testing and device design challenges, has acquired Vante Inc., Tucson, AZ, a global leader in radiofrequency thermal forming equipment. Vante designs, develops and manufactures process systems for the disposable medical device and biopharmaceutical industries.

Bruker Corporation, Billerica, MA, a leading provider of high performance scientific instruments, has acquired Prairie Technologies, Inc., Middleton, WI, a provider of life science fluorescence microscopy products.

Golden Equity Investments, Golden, CO, announced its acquisition of Innovative Medical Device Solutions, Fort Worth, TX, a leading innovation company and contract manufacturer of medical implants and instruments for the orthopaedic market.

Evonik Corporation High Performance Polymers Business Line, Parsippany, NJ, announced a distribution agreement with chemicals, plastics, and composites distributor Nexeo Solutions, The Woodlands, TX, for its VESTAMID® and TROGAMID® product lines used in medical device applications.

Belimed Inc., part of the Belimed Group, Charleston, SC, a world leader in Cleaning and Sterile Processing Systems and Solutions in health care and life sciences, has entered into a strategic partnership with Haldor Advanced Technologies Ltd., Hod Hasharon, Israel, the leading provider of RFID enabled surgical instrument management solutions for the healthcare industry.

ARGO Medical Technologies, Marlborough, MA, has partnered with innovative robotics experts YASKAWA Electric Corporation as it continues the global expansion of its ReWalk exoskeleton device, which enables individuals with lower limb disabilities such as paraplegia to walk. YASKAWA has made a significant capital investment into the ReWalk exoskeleton technology and will also serve as the exclusive distributor for the ReWalk in Japan, China, Singapore, Taiwan, Thailand, and Korea.

Culminating from a three-year relationship involving operational synergies for diagnostic imaging service and equipment solutions, two of the largest multi-vendor service providers in Europe: Medical Equipment Solutions and Applications (MESA), Lugano, Switzerland, and MVS, Mikolow, Poland, have entered into a strategic partnership that significantly increases the commercial and operational offering of the combined entities. This includes MESA assuming a minority ownership position in MVS, and Sebastian Cienki, Founder, President, and CEO of MVS, joining MESA as the Vice President of Pan-European Diagnostic Imaging Service.

Cardinal Components, Inc., Wayne, NJ, a world leader in the manufacturing of programmable oscillators, has entered into a distributor agreement with Sensible Micro Corporation, Tampa, FL, a broad-line stocking distributor and professional sourcing partner.

Miscellaneous

OMAX Corporation, Kent, WA, a global leader in the design, manufacture, and support of advanced abrasive waterjet machines and accessories, has once again made Inc. Magazine’s 500|5000 list of fastest-growing private companies in America. OMAX experienced 101 percent business growth between 2009 and 2012.

Mold-Masters, Georgetown, Ontario, Canada, a global leader in melt delivery and control systems, is marking its 50th anniversary in 2013, claiming nearly 1,000 registered patents.

DELO Industrial Adhesives, Windach, Germany, recorded its 5,000th lamp sold and has quintupled its lamp sales within the past two years. The DELOLUX lamps developed and produced in-house allow easy, fast, reliable and particularly energy-efficient curing of photoinitiated adhesives.

Olympus, Center Valley, PA, a precision technology leader in designing and delivering innovative medical and surgical solutions, announced the launch of a cutting-edge website for its medical business. The new site is designed to make it easier to find products, services, and a range of solutions. Visit Olympus at http://www.medical.olympusamerica.com/.

The Medical Technology Veterans Program second annual MVP Boot Camp took place during the 2013 AdvaMed MedTech Conference in Washington, DC last week. The program is a year-long career training and mentorship program designed to help veterans entering the civilian workforce transition into jobs in the medical technology and diagnostic industries. Fourteen veterans from across the country participated. For more information, log on to: http://www.medtechvets.org.

The 2nd annual Medical Device and Diagnostic Trainers Summit will take place on October 8 and 9, 2013, at the Hyatt Regency Indianapolis in Indianapolis, IN. It is sponsored by the Society of Pharmaceutical and Biotech Trainers (SPBT), the only association solely devoted to strengthening training in the healthcare industry. For more information, visit: http://www.MDD2013.com.

K2M, Inc., Leesburg, VA, focused on developing innovative solutions to treat complex spinal pathologies and minimally invasive procedures, has entered the spinal device market in France. The first surgical case was performed using the company’s MESA® Deformity Spinal System.