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

Regulatory Approvals, Standards, and Launches

EOS imaging, Paris, France, a pioneer in 2D/3D orthopedic medical imaging, has won CE Mark certification for for its spineEOS 3D planning software for spinal surgery based on EOS bi-planar imaging.

Edwards Lifesciences Corporation, Irvine, CA, a global leader in innovations for structural heart disease and critical care monitoring, announced FDA approval to expand use of the Edwards SAPIEN XT transcatheter heart valve for pulmonic valve replacement procedures.

CoorsTek Medical, Fort Worth, TX, a leading manufacturer of advanced implantable ceramic components, announced that its CeraSurf®-p ceramic femoral heads have been incorporated into a US orthopaedic device company’s hip system that has received FDA 510(k) clearance.

ScandiDos, Uppsala, Sweden, a worldwide leader in the development of advanced dosimetry, announced that its Delta Discover™ received FDA 510(k) clearance, bringing to market the first device that independently verifies the radiation dose delivered to a patient during radiation treatment.

W.L. Gore & Associates, Inc. (Gore), Flagstaff, AZ, announced that it has received FDA approval of the GORE® EXCLUDER® Iliac Branch Endoprosthesis, making it the first off-the-shelf aortic branch device approved in the US and the only device indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.

Stryker, Kalamazoo, MI, one of the world's leading medical technology companies, announced that its Spine division has received FDA 510(k) clearance for its Tritanium PL Posterior Lumbar Cage, an intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease.

Life Spine, Huntley, IL, which designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that the FDA has given 510(k) marketing clearance to its PROLIFT Expandable Interbody System, which the company says restores disc height, in-situ, for minimally invasive PLIF, TLIF and oblique approaches.

BioMedical Enterprises Inc., San Antonio, TX, a manufacturer focused the use of memory metal implants for bone fixation, said that it has launched its Elite nitinol bone fixation system in the US, which features fixation recovery technology to allow implants to maintain compression through repetitive loading.

St. Jude Medical, Inc., St. Paul, MN, a leading global medical device manufacturer, has won CE Mark certification for magnetic resonance conditional labeling for its Nanostim leadless pacemaker.

Parker Hannifin Corporation, Cleveland, OH, a global leader in motion and control technologies, announced that it has received FDA clearance to market and sell the Indego® exoskeleton for clinical and personal use in the United States.

Boston Scientific, Marlborough, MA, a worldwide developer, manufacturer, and marketer of medical devices whose products are used in a range of interventional medical specialties, has received FDA approval for its Blazer Open-Irrigated radiofrequency ablation catheter to treat Type I atrial flutter.

Intuitive Surgical, Inc., Sunnyvale, CA, a global leader in robotic-assisted minimally invasive surgery, announced that it has received FDA 510(k) clearance for its da Vinci® Xi™ EndoWrist Stapler 30 instruments and reloads.

Leadership News

Nevro Corp., Redwood City, CA, announced that Michael DeMane, Nevro's Chief Executive Officer since March 2011, will transition to the role of Executive Chairman of the Board of Directors effective June 1. Also on that date, Rami Elghandour, Nevro's current President, will assume the role of President and Chief Executive Officer.

Sunshine Heart, Inc., Eden Prairie, MN, an early-stage medical device company focused on developing, manufacturing, and commercializing the C-Pulse System to treat Class III and ambulatory Class IV heart failure, announced the appointment of John Erb as its fulltime Chief Executive Officer and President, effective immediately.

Electromed, Inc., New Prague, MN, maker of the SmartVest Airway Clearance System, announced that John Kowalczyk has joined the company as Vice President of Sales and will oversee all domestic sales initiatives.

Cook Group, Bloomington, IN, which combines medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently, announced the promotion of Barry Slowey to president of Cook Endoscopy/Cook Winston-Salem. He will oversee the various functions in Winston-Salem, NC, and will maintain leadership responsibility for the endoscopy clinical division.

Cardiovascular Systems Inc., St. Paul, MN, which is devoted to developing and commercializing solutions to treat peripheral and coronary vascular disease, has announced that David Martin, the company’s President and CEO, will be stepping down due to illness and that Chairman Scott Ward will remain as Interim President and CEO as the company searches for Martin’s successor.

CorMatrix Cardiovascular, Inc., Roswell, GA, a leading developer of biomaterial compositions and medical devices for regenerative medicine, has appointed Andrew M. Green as President and Chief Operating Officer, and Patrick R. Ferguson as National Sales Director.

ZOLL®Medical Corporation, Chelmsford, MA, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced that effective April 1, Chief Executive Officer Richard A. Packer will assume a new role leading the global Health Care Business Unit; Jonathan A. Rennert, currently President of ZOLL’s resuscitation business, will become CEO of ZOLL, and A. Ernest Whiton, now Senior Vice President of International Operations, will replace Rennert as President of ZOLL’s resuscitation business.

Expansions/Spinoffs/New Services/Moves

Johnson & Johnson Innovation LLC opened JLABS@TMC (Texas Medical Center), Houston, TX, a new 34,000-square foot life sciences incubator providing entrepreneurs shared lab space, private offices, and modular laboratory suites, as well as state-of-the-art equipment and value-added operational, education, and business services. The facility can accommodate up to 50 startups, and is the first site to open with a medical device prototype lab, including a 3D printer.

AXYZ International, Burlington, Ontario, Canada, a leading global manufacturer of CNC router and knife cutting systems, announced the opening of its newest office in Tampa, FL, making a total of four US offices. The others are in Atlanta, Cincinnati, and Los Angeles.

Cirtec Medical, LLC, East Longmeadow, MA, a leading provider of design and contract manufacturing services for active implantable and minimally invasive devices, has announced the opening of its new 38,000-square-foot manufacturing facility in Enfield. CT.

IPC, the Association Connecting Electronics Industries, Bannockburn, IL, the global industry association representing all facets of the electronics industry, announced the official opening of a new office in Brussels, Belgium. The office will deliver the full suite of IPC products and services, including member support, standards development activities, educational opportunities, and more to all members in Europe.

Varian Medical Systems, Palo Alto, CA, which is one of the world’s leading manufacturers of medical devices and software to treat cancer and other medical conditions with radiation, broke ground on its proposed 50,600-square-foot facility in Jundiai, Brazil. The facility, which is expected to be completed in the second half of 2017, will include a radiotherapy training center, demonstration rooms, manufacturing, warehousing, and radiotherapy equipment servicing.

Orchid Orthopedic Solutions, Holt, MI, has announced that the company will offer vacuum titanium plasma spray coating services at its Suzhou, China, facility beginning this year.This expansion of capabilities supports Orchid's strategy to provide full value stream services to the local market in Asia and compliments their current hydroxylapatite coating services.

In April, RAUMEDIC AG, Helmbrechts, Germany, a worldwide development partner and system supplier for medical tubing, injection molded parts, and catheters, will open its first US development center and state-of-the-art production facility in Mills River, NC.

Mergers/Acquisitions/Collaborations/Licensing

Zimmer Biomet, Warsaw, IN, a global leader in musculoskeletal healthcare, has acquired Ortho Transmission, LLC, Denver, CO, a provider of transcutaneous osseous integrated skeletal implant technology.

Dynawave Cable Inc., Haverhill, MA, a top developer and supplier of high-performance RF/microwave coaxial connectors, cables, and cable assemblies, has announced a new global distribution agreement with Richardson Electronics, Ltd., LaFox, IL, a leading supplier of high-frequency and high-power devices and components for commercial, industrial, and military/aerospace markets and applications.

Invibio Knee Ltd., a subsidiary of Invibio Biomaterials Solutions, Thornton Cleveleys, UK, has partnered with Maxx Orthopedics, Inc., Plymouth Meeting, PA, which designs, develops, and supplies joint replacements, to develop a PEEK-OPTIMA® femoral knee replacement.

Praxair, Inc., Danbury, CT, the largest industrial gases company in North and South America and one of the largest worldwide, has acquired NOxBOX Ltd., Maidstone, Kent, UK, which specializes in the manufacture of inhaled gas delivery and monitoring instruments for the medical market.

International TechneGroup Limited, Cambridge, UK, a global leader providing reliable interoperability, validation, and migrationsolutions for product data and related systems, has teamed with Endocon Engineering GmbH, Neckargemünd, Germany, a consulting firm specializing in product development and manufacturing processes as a value-added referral partner.

PromptCare, Clark, NJ, a leading regional provider of specialty respiratory products and infusion therapy services, announced it has recently acquired Boston Home Infusion, Stoughton, MA, which provides home infusion therapies throughout the greater Boston area.

Bionik Laboratories Corp., Toronto, Canada, a medical device and robotics company focused on developing transformational technologies and solutions for individuals with neurological disorders, has signed an agreement to merge with Interactive Motion Technologies, Boston, MA, a provider of robotic tools for neurorehabilitation.

Ethicon, Cincinnati, OH, a medical device company of the Johnson & Johnson family of companies, announced a definitive agreement to acquire NeuWave Medical, Inc., Madison, WI, which manufactures and markets minimally invasive soft tissue microwave ablation systems.

BD (Becton, Dickinson and Company), Franklin Lakes, NJ, a leading global medical technology company, announced a definitive agreement to sell 50.1 percent of its Respiratory Solutions business to funds advised by Apax Partners, London, UK, a leading global private equity firm, and form a joint venture that will operate as a new, independent company that includes all business lines within BD's Respiratory Solutions business including Ventilation, Respiratory Diagnostics, Vital Signs, and AirLife.

Hoffmann + Krippner, Inc., Alpharetta GA, which specializes in input and output systems and sensor technology, announced that TES Frontdesign, Neuruppin, Germany, a leading provider of individual operating systems, has engaged in a joint venture with Hoffmann + Krippner as their new majority owner. This enables H+K to provide a wider array of sensing & input products and technologies to US- and Canada-based electronics developers and manufacturers.

Hitachi Medical Systems America, Inc., Twinsburg, OH, which offers a broad range of diagnostic imaging equipment, has entered into a partnership with Redlen Technologies, Saanichton, BC, Canada, a leading manufacturer of high resolution Cadmium Zinc Telluride semiconductor radiation detectors, to jointly develop a direct conversion semiconductor x-ray detector module necessary for new photon counting computed tomography systems.

NuVasive, Inc., San Diego, CA, a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, has entered into a definitive agreement to acquire Mega Surgical, Rio de Janeiro, Brazil, which was founded as an implantable medical device distribution company, and is the exclusive distributor of NuVasive products in Brazil.

StackVelocity, San Jose, CA, a division of Jabil Circuit, Inc., a leading open source cloud solution provider,announced that it has launched production of its Open Compute Project HatTrick Storage solution, which is offered through its OPC solution provider Penguin Computing, Fremont, CA, which provides high-performance computing, enterprise data center, and cloud solutions, in order to distribute the solution to a wider diversity of enterprises and Tier 2 service providers.

Canon Inc., Tokyo, Japan, which makes X-ray machines and eye examination devices, has won the exclusive right to negotiate with Toshiba Corp., Tokyo, Japan, for its medical device business, Toshiba Medical Systems Corp., which is the world's second-largest manufacturer of CT scan machines.

Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, has acquired Test & Measurement Solutions, Hasselt, Belgium, which develops multidisciplinary solutions to test, measure, inspect, assemble, and validate products in nearly all segments of the production industry.

CTS Corporation, Lisle, IL, a leading designer and manufacturer of sensors, actuators, and electronic components, has acquired CTG Advanced Materials, LLC, Bolingbrook, IL, which formerly operated as H.C. Materials, and is a leading designer and manufacturer of single crystal piezoelectric materials, serving OEMs throughout the medical marketplace.

Miscellaneous

In 2016 Cook Medical, Bloomington, IN, will celebrate 20 years of operations Limerick, Ireland, where it has grown from a team of fewer than a dozen people to a staff of more than 800, providing minimally invasive technologies that are designed to eliminate the need for open surgery for in the areas of gastroenterology, peripheral vascular intervention, and urology.

Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, and medical device industries, was recognized as the 2015 Business of the Year in St. Croix County by the St. Croix Economic Development Corporation.