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

Regulatory Approvals, Standards, and Launches

Mitek Sports Medicine, part of DePuy Synthes Companies of Johnson & Johnson, Raynham, MA, a global leader in orthopaedic and neurological solutions, has launched two new arthroscopic surgery radiofrequency devices: the VAPR® TRIPOLAR 90 Suction Electrode and the VAPR ARCTIC® Suction Electrode are hand-held, energy-based devices utilized by orthopaedic surgeons to ablate or coagulate targeted soft tissue.

Biomedical Polymers Inc., Gardner, MA, a manufacturer of plastic consumables for research and medical diagnostics laboratories, has received ISO 13485:2003 certification for its quality management system for the manufacture of medical devices.

Thoratec Corporation, Pleasanton, CA, a leader in mechanical circulatory support therapies for failing hearts, announced that its HeartMate PHP (Percutaneous Heart Pump) has received the CE Mark, permitting its sale in the European Union and other international countries.

Helius Medical Technologies, Inc., Newtown, PA, has received its first patent related to the design of its new Portable Neuromodulation Stimulation 4.0 device, which is being studied in the US to treat chronic balance symptoms.

St. Jude Medical, St. Paul, MN, a global medical device company, has received FDA 510(k) clearance for its Invisible Trial system, a spinal cord stimulator that incorporates Apple products and Bluetooth wireless technology. In addition, the company’s Penta 5-column paddle lead for spinal cord stimulation has received FDA 510(k) clearance.

Integrum AB, Molndal, Sweden, reports that the FDA has approved its new device, called Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA), an external prosthetic limb attaches to a fixture implanted in the patient's remaining thigh bone. It is the first of its kind, a prosthesis for above-the-knee amputations that does not rely on a cup-like socket fitting over the stump of a patient's leg.

ChoiceSpine, Knoxville, TN, a spinal implant company, has been granted ISO certification for its quality management system for the development, manufacture, and distribution of its devices.

Escatec Medical Sdn Bhd, part of the Escatec Group based in Penang, Malaysia, is now FDA registered as a medical device contract manufacturer for the US medical device market.

Abbott, Abbott Park, IL, a global pharmaceutical and healthcare products company, announced that it has received FDA approval for, and has launched, its iDesign Advanced WaveScan Studio System, which is used with the LASIK procedure, generating a high-definition scan that measures and maps irregularities of the eye that may impact vision.

Medrobotics Corp., Raynham, MA, a surgical robotics company, has received FDA clearance to market the Flex® Robotic System and is initiating its commercial launch in US hospitals. It received European CE mark clearance in March 2014.

Oxford Performance Materials, Inc., South Windsor, CT, a leading advanced materials and additive manufacturing company, has received FDA 510(k) clearance for its first-in-kind SpineFab® vertebral body replacement (VBR) implant system intended to replace a collapsed, damaged, or unstable vertebral body.

C2 Therapeutics, Redwood City, CA, founded to improve treatment of precursors to esophageal cancer, has received FDA 510(k) clearance for its Coldplay Cryoballoon™ Full Ablation System and the Coldplay Cryoballoon™ Swipe Ablation System.

LuxCath LLC, Boston, MA, a medical technology company developing catheter-based real-time tissue contact assessment and lesion visualization technology, has received a US patentfor its “Systems and Methods for Visualizing Ablated Tissue.”

Dynatronics Corporation, Salt Lake City, UT, which manufactures advanced technology medical devices, treatment tables, and rehabilitation equipment, has won CE Mark certification for its Solaris line of therapeutic modality products.

Leadership News

Sparta Systems Inc., Hamilton, NJ, a leading provider of enterprise quality management software solutions, has promoted Steve Buonaiuto to Chief Operating Officer. He will also continue to serve as the company’s Chief Financial Officer.

Richardson Electronics, Ltd., LaFox, IL, a global provider of engineered solutions, has hired Jens Ruppert as its Executive Vice President and General Manager of Canvys, Marlborough, MA, the company’s visual technology solutions group providing custom displays for medical and industrial OEMs.

NuVasive, Inc., San Diego, CA, a leading medical device company focused on minimally disruptive, procedurally-integrated solutions for spine surgery, announced that Jason Hannon was appointed Executive Vice President, International. He will be headquartered in Amsterdam.

IlluminOss Medical, East Providence, RI, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, announced the appointment of Clive V. Ridgwell as Vice President of Sales.

Vestagen Technical Textiles, Inc., Orlando, FL, announced a number of additions and changes to its leadership team. Barbara DeBaun, RN, MSN, CIC,has been named Consulting Vice President of Clinical Affairs, Stewart B. Davis, MD, has been named Consulting Vice President of Regulatory and Medical Affairs, and Marc Lessem has joined as Chief Marketing Officer and Senior Vice President of Sales and Marketing. Executive Chairman Dale Pfost, PhD, has assumed the additional role of Chief Executive Officer and Vestagen founder Uncas “Ben” B. Favret lll has been named President.

TÜV Rheinland, Newtown, CT, a full-service inspection, testing and certification company, has appointed Greg Smith to the position of Senior Field Evaluation Inspector for North Carolina and surrounding regions.

Toshiba America Medical Systems, Inc., Tustin, CA, announced that Satrajit Misra has been named Vice President, Marketing.

Titan Spine, Mequon, WI, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, has appointed Jim Sevey as the company’s Senior Nanotechnology Specialist.

Expansions/Spinoffs/New Services/Moves

The Department of Defense has announced that the Research Foundation for the State University of New York (RF SUNY) in the Rochester, NY, area will lead a newly-created Manufacturing Innovation Institute for Integrated Photonicsto boost advanced manufacturing, build on the area’s legacy of leading optical and photonics technology capabilities, and position the US for continued leadership in this critical technology area.

Saki Corporation, Tokyo, Japan, a leader in the field of automated optical inspection equipment, announces that Saki America Inc. has moved its headquarters to Fremont, CA, which will serve as a sales, training, service, and application support facility for Saki's 2D and 3D automated optical, solder paste, and x-ray inspection systems.

Trademark Plastics, Inc., Riverside, CA, a custom injection-molding company supplying components to themedical device manufacturingindustry, plans to open a newmedical device manufacturingplant in Tijuana, Mexico, in the fourth quarter of 2015 or first quarter of 2016. The 33,000 sq. ft. plant will include a 20,000 sq. ft. Class 100,000 clean room, 15 injection-molding machines, and an assembly line.

Merit Medical Systems, Inc., South Jordan, UT, a leading manufacturer and marketer of proprietary disposable devices used in cardiology, radiology, and endoscopy, has expanded its Europe, Middle East, and Africa (EMEA) distribution center and corporate office in Maastricht, The Netherlands.

HSI Sensing, Chickasha, OK, a leader in the engineering and precision manufacturing of custom reed switch and sensor technology, has opened a new development lab in Madison, WI, that will focus on manufacturing technology, processes, and efficiencies.

Parker Hannifin, Cleveland, OH, a diversified manufacturer of motion and control technologies and systems and a medtech contract manufacturer, intends to close medical systems division facilities in Anaheim and Fontana, CA, consolidate several divisions, and construct a new manufacturing capacity in Mexico.

Mergers/Acquisitions/Collaborations/Licensing

TÜV Rheinland North America, Newtown, CT, a full service testing, inspection, and certification company and Korea Testing Laboratory, Seoul, South Korea, have agreed to continue their exclusive testing and certification partnership. Under the terms of the agreement, consumer electrical and medical devices tested and certified in one country would be recognized and certified as conforming to equivalent standards in the corresponding country. This is the second time the two testing bodies have renewed their pledge of cooperation.

Medtronic plc, Dublin, Ireland, a global leader in medical technology, will acquire RF Surgical Systems, Carlsbad, CA, which specializes in the detection of retained surgical items such as sponges, gauzes, or towels.

Victrex Polymer Solutions, Thornton Cleveleys, UK, a world leader in high performance PEEK polymer-based solutions, has acquired polymer gears specialist Kleiss Gears, Grantsburg, WI.

Integra LifeSciences, Plainsboro Township, NJ, a leader in regenerative technologies, specialty surgical solutions, orthopedics, and tissue technologies, has acquired TEI Biosciences, South Boston, MA, and sister company TEI Medical, Waltham, MA, both involved in regenerative technology, expanding Integra’s footprint in reconstructive surgery and regenerative wound care.

St. Jude Medical, St. Paul, MN, a global medical device manufacturer, has agreed to purchase Thoratec, Pleasanton, CA, a worldwide leader in mechanical circulatory support technology to treat advanced heart failure.

ITTIA, Bellevue, WA, which offers database solutions for platforms where limited memory, storage, and processing power makes software development challenging, and Micrium, Inc., Weston, FL, a global RTOS leader for microprocessor-, microcontroller- and DSP-based devices, are teaming up to bring advanced SQL database, scalability, multitasking, and reliability to medical device manufacturers using microcontrollers and DSPs. ITTIA will support Micrium uC/OS-II® and uC/OS-III® real-time operating systemsin its flagship embedded database product, ITTIA DB SQL.

Synopsys, Inc., Mountain View, CA, a global leader in electronic design automation and semiconductor IP, has signed a definitive agreement to acquire Atrenta Inc., San Jose, CA, a provider of SoC realization solutions for the semiconductor and consumer electronics industries.

Profound Medical, Toronto, Ontario, Canada, which is developing and commercializing technology to treat prostate cancer, has partnered with Royal Philips, The Netherlands, a global diversified healthcare company, to develop Profound’s novel, minimally invasive prostate gland ablation tool to be used on Philips' MRI systems.

IDEX Corporation, Lake Forest, IL, an applied solutions company specializing in fluid and metering technologies and dispensing equipment, has acquired CIDRA Precision Services, LLC, Wallingford, CT, a leader in the design, manufacture, and sale of microfluidic components serving the life science, health, and industrial markets.

Bacterin International Holdings Inc., Belgrade, MT, a leader in the development of bone graft material, has agreed to acquire X-spine Systems, Inc., Miamisburg, OH, a global medical device manufacturer of leading products for spinal surgery. Bacterin International Holdings, Inc. will change its name to Xtant Medical Holdings, Inc. Dr. David Kirschman, currently X-spine CEO, will join the management team and serve as Executive Vice President and Chief Scientific Officer of Xtant Medical Holdings, Inc. He will also be President of X-spine Systems, the hardware subsidiary.

Miscellaneous

Qosina, Edgewood, NY, which supplies thousands of stock components to medical device companies, has established a new e-commerce site. See https://www.qosina.com .

The OMRON Foundation, Inc., Hoffman Estates, IL, has donated $25,000 to Illinois FIRST to promote hands-on Science, Technology, Engineering and Math (STEM) education for young people. The OMRON Foundation coordinates the charitable efforts of all US and Canadian offices of OMRON Corporation, Kyoto, Japan, a global leader in electronics manufacturing.

Cadence, Inc., Staunton, VA, a leading contract manufacturer of advanced products, technologies, and services to the medical, life science, and industrial markets, celebrates 30 years in business. Originally founded as Specialty Blades in 1985, the company was developed with the concept of combining Computer Numerical Control and razor blade sharpening technologies to address the needs of companies requiring high-performance custom-made blades.

Coaxial Components Corp., Stuart, FL, which specializes in the manufacture of RF connectors, attenuators, terminations, adapters, torque wrenches, phase adjusters and cable assemblies, has introduced an improved tool for cross referencing the company’s extensive database of RF components to help customers find products that are equivalent, similar, substitute or alternate replacements to products of other manufacturers. See www.coaxicom.com .

Fabrisonic LLC, Columbus, OH, a manufacturer of ultrasonic additive manufacturing machines and 3D metal printing, has received a Boeing 2014 Performance Excellence Award signifying that it has achieved superior performance and provided outstanding service.

LDRA, Wirral, UK, a leader in standards compliance, automated software verification, source code analysis, and test tools, announced that Version 9.5 of its LDRA tool suite has received the VDC Research Embeddy Award at ESC Silicon Valley.