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

Regulatory Approvals, Standards, and Launches

StimGuard, Miami, FL, a pre-commercial stage medical device company, has received FDA Investigational Device Exemption approval to launch a clinical trial of its passive microsize implantable device to treat Overactive Bladder Syndrome.

Medtronic plc, Dublin, Ireland, a global leader in healthcare, announced that its Arctic Front Advance® ST Cryoablation Catheter has received FDA approval to treat atrial fibrillation.

Ablative Solutions, Inc., Kalamazoo, MI, announced that it has received CE Mark approval for its Peregrine System Infusion Catheter to treat uncontrolled hypertension.

Dassault Systèmes, Vélizy-Villacoublay, France, a world leader in 3D design software, 3D digital mock up and product lifecycle management solutions, announced that the first heart model from its “Living Heart Project ” will be commercially available on May 29. The commercial, high-fidelity scientifically validated 3D simulator of a four-chamber human heart is the first product of its kind. With this model, device manufacturers, researchers, and medical professionals will be able to perform virtual tests and visualize the heart’s response in ways that are not possible with traditional physical testing.

Nevro Corp., Menlo Park, CA, a medical device company developing products to treat chronic pain, announced that it has received FDA approval for its Senza spinal cord stimulation system.

St. Jude Medical, Inc., St. Paul, MN, a global medical device company, announced that it has received the CE Mark for expanded labelling for its Ellipse™ implantable cardioverter defibrillator, which can allow patients with these technologies to undergo magnetic resonance imaging scans.

BD Medical, Franklin Lakes, NJ, a segment of leading global medical technology company BD (Becton, Dickinson and Company), has received FDA 510(k) clearance for a new insulin infusion set with BD FlowSmart™ technology. The new product is BD’s first within the diabetes infusion set category.

Ellipse Technologies, Inc., Irvine, CA, involved in the design, development, and successful commercialization of implants for spinal and orthopedic applications, has received FDA 510(k) clearance to market its next generation external remote controller for use with its MAGnetic Expansion Control Spinal Bracing and Distraction System.

LabStyle Innovations Corp., Caesarea, Israel, developer of the Dario™ Diabetes Management Solution, has been granted Health Canada approval to market and sell Dario™ in Canada through its exclusive distributor in Canada Auto Control Medical Inc., Mississauga, Ontario, a Canadian leader in medical devices for home use. Dario turns any smart device into a personal glucose meter.

BrainScope Company Inc., Bethesda, MD, a neurotechnology company, announced that the FDA has cleared its Ahead 200 device, which records and analyzes a patient’s electroencephalograph using a custom sensor to assess traumatic brain injury.

Invictus Medical, San Antonio, TX, which is dedicated to providing newborns with healthy developmental milestones, has received FDA clearance to begin marketing its GELShield™ extracranial pressure relief device.

Leadership News

Lee Spring, Brooklyn, NY, announced the appointment of Jim Callaghan to the newly created position of Executive Vice President of Business Development.

Pasternack Enterprises, Inc., Irvine, CA, a leading manufacturer and supplier of RF, microwave, and millimeter wave products, has appointed Bruce Yolken as the company’s Quality Assurance Manager.

Pelican Products, Torrance, CA, a global leader in the design and manufacture of high-performance protective cases and advanced portable lighting systems, has promoted Stephan Corti to President of its newly structured traditional Commercial and Government Division.

Spectronics Corporation, Westbury, NY, a leading manufacturer of ultraviolet equipment and fluorescent materials, has promoted Debra Hammond to Global Customer Service Manager.

Expansions/Spinoffs/New Services/Moves

Phillips-Medisize Corporation, Hudson, WI, a global-leader in outsource design, development, and technology-driven manufacturing of medical devices, announced the opening of its new design and development center in Suzhou, China. The design and development center supports patient-administered biologics and pharmaceutical drug delivery, and diagnostics device design and development services for regional and global customers.

Orchid, Holt, MI, a worldwide leader in contract design and manufacturing for the orthopedic and medical device markets,has opened a new facility in Pune, India, which will focus on precision-machined parts. The company plans to add a clean room for sterile packaging services and finishing and coating services. The legal name for the new entity is Orchid India Medisolutions Private Ltd.

Gordon Brush, Commerce, CA, a leading manufacturer of specialty, custom, and standard brushes, has acquired a new facility more than three times larger than its existing facility. The company’s factory and offices will move to the City of Industry, CA, this summer.

Cadence, Inc., Staunton, VA, broke ground on a new state-of-the-art production facility located in Sturgeon Bay, WI, nearly three times the size of its current space, which provides precision metal stamping for complex components used in medical, automotive, and industrial applications.

Mergers/Acquisitions/Collaborations/Licensing

Molex Incorporated, Lisle, IL, a global manufacturer of complete interconnect solutions, announced the acquisition of ProTek Medical Ltd., Sligo, Ireland, by Molex Ireland Holdings B.V. ProTek Medicalspecializes in supplying custom solutions for medical device manufacturers in the global medical industry and will operate as a subsidiary of Molex Ireland Holdings, B.V.

LDRA, Wirral, UK, a leader in standards compliance, automated software verification, source code analysis, and test tools, and Green Hills Software, Santa Barbara, CA, a global leader in high-assurance operating systems, have partnered to provide high-assurance application development on multicore platforms used in safety- and security-critical markets.

Debiotech SA, Lausanne, Switzerland, has entered into an agreement with iSense CGM, Inc., Wilsonville, OR, whereby Debiotech has received an exclusive rights option on the iSense Continuous Glucose Monitoring technology for use with patch pumps for diabetes therapy.

Gardner Denver Medical Group, Fuerstenfeldbruck, Germany, a leader in flow control solutions for medical and laboratory sectors, has acquired TriContinent Scientific, Inc., Grass Valley, CA, a leading manufacturer of OEM precision syringe pumps.

LabStyle Innovations Corp., Caesaria, Israel, developer of the Dario™ Diabetes Management Solution, has partnered with Israel's leading HMO, Maccabi Healthcare, to launch the comprehensive Dario™ Diabetes Management Solution as part of Maccabi’s advanced Telecare unit. Dario enables remote treatment for diabetes aiming to improve overall outcomes for patients.

Miscellaneous

COMSOL, Inc., Burlington, MA, announced that its program committee for the 11th annual COMSOL Conference invites engineers and researchers to submit paper and poster abstracts to be considered for presentation at the world’s largest conference on multiphysics simulation. Papers, presentations, and posters from the COMSOL Conference are shared with more than 165,000 engineers worldwide. The deadline to submit an abstract for the COMSOL Conference Boston is July 31, 2015. See instructions at: www.comsol.com/conference2015/call-for-papers .

Amada Miyachi America, Inc., Monrovia, CA, a leading manufacturer of welding, marking, cutting, and micro machining equipment and systems, recently donated an LMF2000 fiber laser marker along with related safety equipment to Workshops for Warriors (WFW) , a nonprofit organization that provides vocational training to returning, wounded, and disabled veterans of the US Armed Services. Partnering in the donation is Technimark, one of Miyachi’s suppliers, which donated a fume extractor for the equipment, and Directed Light, Inc., which donated laser safety glasses.

Rogers Corporation, Chandler, AZ. a global technology leader in high-performance printed circuit materials, announced that its division previously known as Advanced Circuit Materials is changing its name to Advanced Connectivity Solutions, representing a shift in its printed circuit materials segment expanding into new areas of RF/Microwave and Digital connectivity.