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

Regulatory Approvals, Standards, and Launches

The Diabetes Technology Society, Foster City, CA, released its cybersecurity standard for networked-connected smart medical devices. The public platform, called DTSec, contains a set of performance requirements to improve cybersecurity through independent expert security evaluation.

Corvia Medical, Inc., Tewksbury, MA, which is developing first-in-class transcatheter structural heart devices, has received CE Mark approval for its InterAtrial shunt device designed to treat diastolic heart failure.

EndoGastric Solutions, Redmond, WA, has received FDA 510(k) clearance for its EsophyX Z device, which is intended to provide gastroesophageal barrier function restoration in transoral incisionless fundoplication procedures.

Orthofix International N.V., Lewisville, TX, focused on providing superior reconstructive and regenerative orthopedic and spine solutions, has received FDA 510(k) clearance for its FORZA® PTC™ (Peek Titanium Composite) Spacer System for lumbar spine fusion procedures.

Hospira, Lake Forest, IL, a Pfizer company and a leading provider of infusion technologies, announced the launch of its LifeCare PCA® 7.0 Infusion System, the first patient-controlled analgesia infusion pump.

Perimeter Medical Imaging, Toronto, Ontario, Canada, which is focused on the development and commercialization of advanced clinical imaging products, announced that it has received FDA approval for its OTIS optical coherence tomography system, which is designed to produce images of excised human tissue microstructures.

Biotronik International, Berlin, Germany, announced the US launch of its CardioMessenger Smart, which is a portable monitoring device that delivers a patient’s cardiac monitor results, pacemaker and implanted cardioverter defibrillator status directly to their doctor.

Advanced Cooling Therapy, Chicago, IL, which develops products to warm or cool patients, has earned an expanded CE Mark for its Esophageal Cooling Device in the EU, which can now be used for up to 120 hours in patients in need of warming or cooling.

Oakley Die & Mold, Mason, OH, which delivers tooling and machined parts to customers in medical, safety, transportation, industrial machine and other industries, has received ISO 13485 certification.

Leadership News

Flowonix Medical, Inc., Mount Olive, NJ, focused on implantable drug delivery technology, announced that Larry Heaton has been appointed President and Chief Executive Officer, and will serve on the company’s Board of Directors.

Dr. Hans J. Langer, Founder and CEO of EOS GmbH, Krailling, Germany, a global technology and quality leader for high-end additive manufacturing solutions, has received the SME Additive Manufacturing Industry Achievement Award.

Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device industry, announced the appointment of Richard Even as General Manager of BioPharma and the company’s medical campus in Menomonie, Wisconsin.

Expansions/Spinoffs/New Services/Moves

Honeywell, Morris Plains, NJ, a Fortune 100 diversified technology and manufacturing leader, announced its intention to spin off its Resins and Chemicals business into a standalone company named AdvanSix Inc. Upon completion of the spin-off in early 2017, AdvanSix will be an independent, global, leading manufacturer of Nylon 6, used to produce engineered plastics, fibers, filaments, and films.

Amada Miyachi America Inc., Monrovia, CA, a leading manufacturer of resistance welding, laser welding, marking, cutting, and micro machining equipment and systems, celebrated the opening of its new headquarters— a $13.5 million 85,000 square foot facility with 11 application-specific product demonstration labs, a state-of-the-art training room, and a technology showroom as well as an all-new manufacturing facility with a 1,400 square feet Class 10000 clean room and 6 customer test labs.

MEDIAN Technologies, Sophia-Antipolis, France, a medical imaging software maker and developer, has opened a major facility for its US subsidiary MEDIAN Technologies Inc., in Woburn, MA, where it intends to consolidate its Boston-area operations.

Delphinus Medical Technologies, Plymouth Township, MI, a developer of tomographic ultrasound, has moved its headquarters to Novi, MI. The new facility is almost triple the size of the previous site.

Harbor Designs and Manufacturing, Baltimore, MD, a multi-industry contract manufacturer, has opened a 45,000-square-foot facility for a large-scale product assembly system and expects to be able to hire as many as 200 people as it grows into its new space.

Varian Medical Systems, Palo, Alto, CA, the world's leading manufacturer of medical devices and software to treat cancer and other medical conditions with radiation, announced that it plans to spin off its Imaging Components business, a high-volume manufacturer of X-ray tubes, flat panel detectors, connectors and accessories for imaging, as a new, stand-alone public company that’s anticipated to be completed by the end of calendar year 2016.

Mergers/Acquisitions/Collaborations/Licensing

Medtronic plc, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, and Qualcomm Incorporated, San Diego, CA, a world leader in 3G, 4G and next-generation wireless technologies, through its wholly-owned subsidiary, Qualcomm Life, Inc., announced a global, multi-year collaboration to jointly develop future generation continuous glucose monitoring systems designed to improve health outcomes for people with diabetes.

Zimmer Biomet Holdings Inc., Warsaw, IN, a global leader in musculoskeletal healthcare, has completed its acquisition of Cayenne Medical Inc., AZ, which designs, develops and markets soft tissue repair and reconstruction products for the knee, shoulder, and extremities.

Smith & Nephew, London, UK, Europe’s largest manufacturer of artificial hips and knees, has agreed to sell its gynecology unit to Medtronic plc, Dublin, Ireland, the world's largest standalone medical device maker. The acquisition is expected to close this summer. Medtronic also bought a stake in robotics company Mazor Robotics Ltd., Caesarea, Israel, and signed an agreement to use Mazor's robotic surgical guidance systems.

GF Machining Solutions, Geneva, Switzerland, a division of GF, has agreed to purchase Microlution Inc., Chicago, IL, a specialist in micro-machining based on milling and laser technologies.

Senseonics Holdings, Inc., Germantown, MD, a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring system for people with diabetes, has signed an exclusive distribution agreement with Roche Diabetes Care, Inc., Indianapolis, IN, a pioneer in the development of blood glucose monitoring systems, to promote, market, and sell the Senseonics’ Eversense® Continuous Glucose Monitoring System in Germany, Italy, and the Netherlands.

Miscellaneous

Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device industry, announced that two of its facilities–Custom in Phillips, WI, and Phillips-Medisize Menomonie in Menomonie, WI–have received the 2015 Wisconsin Corporate Safety Award.

Lexco Cable, Chicago, IL, an ISO 9001:2008 certified manufacturing business, launched its new website at lexcocable.com . The website includes two unique tools, the “Build a Custom Wire Rope Assembly” and “Fabricate a Cablecraft Push-Pull Control.”

SunTech Medical, Morrisville, NC, which supplies clinical grade blood pressure monitoring products and technologies, has launched a new website at www.suntechmed.com .