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

Regulatory News and Approvals

BSI, the British Standard Institution, has been registered by the Malaysian Medical Device Bureau as one of the three Conformity Assessment Bodies approved to date. In this role, BSI will be responsible for independently assessing medical device manufacturers, importers, and distributors to ensure that they comply with the recently passed Medical Devices Act 2012.

CSA Group, Frankfurt, Germany, a leading global testing and certification organization, and BSI, the British Standard Institution, have formed a strategic alliance to provide global market access solutions to clients in the electronic medical device sector. Through this alliance, CSA Group will certify and test electro-medical products to the applicable electrical standards for safety and performance. BSI will provide conformity assessments to regulatory requirements in different regions worldwide (e.g., the CE Mark) as well as certification to the international standard ISO 13485.

IPC–Association Connecting Electronics Industries, Bannockburn, IL, and JPCA, a Tokyo, Japan-based trade association have released electronics manufacturing industry’s first design guidelines for printed electronics, IPC/JPCA-2291, Design Guidelines for Printed Electronics. Providing guidance for consistent, manufacturable design requirements for printed electronics, IPC/JPCA-2291 together with IPC/JPCA-4921, Requirements for Printed Electronics Base Materials, and IPC/JPCA-4591, Requirements for Printed Electronics Functional Materials, establish a firm foundation for this technology.

With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc., Minneapolis, MN, is introducing the first and only implantable neurostimulation systems to treat chronic, intractable back and/or limb pain that are approved by the FDA for conditionally safe full-body Magnetic Resonance Imaging under specific conditions.

Stryker Interventional Spine, Kalamazoo, MI, announced the clearance of FDA 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System, one of the least invasive vertebral augmentation options available on the market, addresses the surgical trend of shifting toward less invasive treatment options.

Teleflex Incorporated, Limerick, PA, announced that its subsidiary Hotspur Technologies, Inc., which Teleflex acquired in June 2012, received FDA 510(k) clearance to market the company’s ARROW® GPSCath® Balloon Dilatation Catheters in Higher Rated Burst Pressure and 80 cm lengths.

Integra LifeSciences Holdings Corporation, Plainsboro, NJ, announced that the Integra® Titan™ Reverse Shoulder System has received 510k clearance from the FDA. Integra expects to begin a limited market release in the US in the third quarter of 2013, and upon CE Mark clearance in Europe, begin a full global commercial launch.

Ambio Health, Stamford, CT, a healthcare technology company specializing in health monitoring systems, today announced that its Ambio Remote Health Monitoring System, a wireless remote health and activity monitoring tool, received Class II FDA Clearance 510(k).

Convergent Dental, Inc., Natick, MA, a privately held dental device and technology company, announced that the FDA has cleared Solea™, the first CO2 laser technology system for both hard and soft tissue use in the oral cavity.

AMETEK Engineered Medical Components, Arlington, MN, has received a US patent for its design for an electrocardiogram (ECG) cable and electrical assembly that exceeds the low-noise and electromagnetic interference standards established by the ANSI/AAMI EC-53 for ECG cable and lead wires.

CorMatrix Cardiovascular, Inc., Atlanta, GA, announced the receipt of three US Patents for replacement heart valves that utilize unique biomaterial called extracellular matrix (ECM). The established leader in cardiac biomaterial, CorMatrix has more than 120 US and international patent applications pending on various ECM-based compositions and structures as well as methods for processing ECM materials and forming the ECM structures.

Dallen Medical, San Clemente, CA, has received FDA 510(k) clearance for a polymer coated Compressyn™ Band for sternal closure.

LDR, Austin, TX, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, has received a letter of approval from the FDA allowing the commercial sale and distribution of the Mobi-C® Cervical Disc (Mobi-C), for one-level indications in the US.

Quantel Medical, Clermont-Ferrand, France, a leader in ophthalmic ultrasound and laser devices, announced that the FDA has approved its Solutis™, an SLT (selective laser trabeculoplasty) glaucoma laser, for clinical use.

Pathogenica, Inc., Boston, MA, has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit that runs on the Ion PGM™ benchtop sequencer. This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.

Leadership News

J-Pac, Somersworth, NH, a full-service contract manufacturing company servicing the medical device, diagnostics, pharmaceutical, and life sciences industries, announced the appointment of Mark Florence as incoming President and Chief Executive Officer.

Creganna-Tactx Medical, Galway, Ireland, announced that Robert B. Hance will join the company as Chief Executive Officer in September 2013, taking over the role from Helen Ryan who has held the position for the last eight years. He has extensive experience in the medical device sector with more than 23 years at Abbott Laboratories, most recently as President of Abbott Vascular.

Phillips-Medisize Corporation, Hudson, WI, announced the appointment of Rob Werge to the position of VP/GM Global Commercial Division. Previously, he spent 24 years with Nypro, where his most recent role was Vice President of Emerging Markets.

TeraRecon, Foster City, CA, a leading provider of enterprise medical image management solutions, announced the appointment of Jeff Sorenson as Senior Vice President responsible for global sales, marketing, and business development.

Alexandria Industries, Alexandria, MN, a high-quality, short lead-time producer of engineered products, announced that Steve Schabel has been promoted to chief sales and marketing officer and Chris Flemming has been named general manager of its Alexandria Extrusion South location in Carrollton, TX.

ERT, Philadelphia, PA, a provider for high-quality patient safety and efficacy endpoint data collection, announced an expansion of its executive management team. It has appointed James (Jim) Corrigan as Executive Vice President and Chief Operating Officer.

Pilgrim Software, Inc., Tampa, FL, a leading provider of Enterprise Quality and Compliance Management solutions, today announced that Stanley Curtis has been appointed Chief Technology Officer and Senior Vice President of Software Engineering for the company.

Kona Medical, Bellevue, WA, announced that Jim Gilmore has joined the company as Senior Vice President of Research and Development. Gilmore was most recently Senior Vice President of Research and Development for FUJIFILM SonoSite, the worldwide leader in point-of-care ultrasound systems.

Dr. Rachael Seidler, a faculty member at the University of Michigan, has been appointed to lead one of the seven integrated scientific research teams currently funded by the National Space Biomedical Research Institute (NSBRI). As team leader, she will help coordinate the studies of scientists at 8 institutions working on 5 projects focused on examining sensory systems, their interactions, and integration with the brain and motor behavior relevant to long-duration space missions.

Expansions/Moves

World Micro, Inc., Roswell, GA, an electronics distributor, announced the rollout of a new business sector to serve the medical device market. In anticipation of entering the medical electronics market space, the company recently earned its ISO-13485 certification.

UL (Underwriters Laboratories), Mounds View MN, a world leader in advancing safety, announced the relocation of its Minnesota operations to accommodate expansion of services offered to the medical and high tech industries. UL is relocating to expand on its existing high-tech and medical safety engineering and testing services to now offer local Human Factors Engineering services, Home Healthcare, as well as access to comprehensive services to support medical and IVD manufacturers with regulatory submissions in global markets.

Gizmo Medical, LLC, Hoffman Estates, IL, a manufacturer of high quality orthopedic surgical instrumentation, announced today the opening of its new facility in Shandong, China. With state-of-the-art manufacturing equipment and a prototype shop, Gizmo Medical produces over 3,500 unique surgical instruments annually. The new facility offers expanded capabilities in electrical discharge machining (EDM) and computer numerical control (CNC) vertical milling and turning.

The ExOne Company, North Huntingdon, PA, a global provider of three-dimensional printing machines and printed products to industrial customers, has purchased land and will soon begin construction on a new facility in Gersthofen, Germany, for production, R&D, warehouse, and office space to support its global growth.

KAISER, Rümlang, Switzerland, celebrated its 65th year of business in precision tool manufacturing. To commemorate its anniversary, KAISER opened a second building, co-located with its newly expanded and improved factory, in order to better facilitate growing business.

Lambda Research Corporation, Littleton, MA, the leading designer and publisher of illumination and optical design software, announces the launch of their new web site featuring the company’s award-winning opto-mechanical design software for layout, optimization, and analysis of illumination systems. The new web site can be visited at: http://www.lambdares.com.

Mergers/Acquisitions/Collaborations

Medtronic, Inc., Minneapolis, MN, a global medical technology leader, announced the closing of the acquisition of Cardiocom, Chanhassen, MN, a developer and provider of integrated telehealth and patient services to manage chronic diseases.

BIT Group, San Diego, CA, has successfully partnered with BioNano Genomics, also of San Diego, to produce the award-winning Irys instrument—part of the Irys System, a revolutionary new genome mapping platform system that allows the study of DNA and the unique aspects of genomes that cannot currently be detected by other methods. The Irys instrument is a Medical Design Excellence Award winner for 2013.

Theragenics Corporation, Buford, GA, a medical device company serving the surgical products and prostate cancer treatment markets, has agreed to a merger with Juniper Investment Company, LLC, New York, NY. The transaction is expected to close in the fourth quarter of 2013.

BC Technical, West Jordan, UT, a leading non-OEM medical imaging solutions provider, has acquired C&G Technologies, Louisville, KY, the largest independent provider of CT solutions.

Versatile Power, Inc., Campbell, CA, a technology leader in the design and manufacture of custom electronic subsystems, announces a new partnership with PowerGate LLC, Santa Clara, CA, to bring enhanced power capabilities to customers in the form of engineered power systems.

The ExOne Company, North Huntingdon, PA, a global provider of 3D printing machines and printed products to industrial customers and rapid prototype + manufacturing (“rp+m”), Avon Lake, OH, jointly announced a collaboration that has added bonded tungsten to ExOne’s portfolio of 3D printing material. The two companies worked to develop the application of bonded tungsten in the design of rp+m’s products to be used in medical imaging to protect people from radiation.

Miscellaneous

The Healthcare Solutions experts at BSI, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union, are offering members of the medical device community exclusive access to global industry experts at three roadshow events in key U.S. cities in September. The event, open to the medical device field, will engage the audience regarding the importance of entering today's European market and preparing for the expectations and changes in the future. The event will take place from 7:30 a.m. to 4:45 p.m. local time in each of the following cities:

Sheraton Palo Alto, Palo Alto, CA – Monday, September 16, 2013

Sheraton Minneapolis West, Minnetonka, MN – Wednesday, September 18, 2013

Marriott Boston Newton, Newton, MA – Friday, September 20, 2013

See: http://www.bsiroadshow.com