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

Regulatory Approvals, Standards, and Launches

Baxter International, Deerfield, IL, which provides a broad portfolio of essential renal and hospital products, has received FDA 510(k) clearance for its AMIA automated peritoneal dialysis system with the SHARESOURCE web-based remote connectivity platform.

Varian Medical, Palo Alto, CA, has received the CE mark for its ProBeam proton therapy system, which is designed to treat certain types of cancer with potentially fewer side effects.

SonaCare Medical, LLC, Charlotte, NC, a pioneer in minimally invasive high intensity focused ultrasound technologies, has received de novo clearance from the FDA to market its Sonablate® 450 in the US for the ablation of prostate tissue.

Safe Orthopaedics, Eragny-sur-Oise, France, a medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, announced that it has received FDA approval to market its new One-Step System implant for repairing traumatic spinal injuries in the US.

Medtronic plc, Dublin, Ireland, a global medical device leader, received the CE Mark for its Visia AF and Visia AF MRI SureScan single-chamber implantable cardioverter defibrillators.

Capsule, Andover, MA, a medical device information systems company and a Qualcomm Life Inc. subsidiary, has received FDA 510(k) clearance for its SmartLinx Vitals Plus, a patient monitoring system that integrates vital signs monitoring and clinical documentation into one scalable platform.

RenovoRx, Los Altos, CA, a developer of solutions for targeted fluid delivery, has received the CE Mark for its RenovoCath™, which is designed to deliver fluids to selected sites in the peripheral vascular system.

AV Medical Technologies Ltd., Tel Aviv, Israel, which is developing solutions to improve visualization during catheter-based interventions, has received FDA clearance for its Chameleon™ angioplasty balloon catheter.

Pryor Medical Devices, Arvada, CO, which designs, develops, and commercializes minimally invasive solutions for vascular trauma, has received FDA 510(k) clearance for its ER-REBOA catheter used to temporarily occlude large vessels using a balloon.

Masimo, Irvine, CA, a global leader in innovative noninvasive monitoring technologies, has received FDA 510(k) clearance for its MightySat Rx, a fingertip pulse oximeter that incorporates Masimo SET® Measure-through Motion and Low Perfusion™ technology.

Leadership News

IlluminOss Medical, East Providence, RI, which is focused on minimally invasive orthopedic fracture repair, has named Manny Avila as its Chief Executive Officer.

Bovie Medical Corporation, Clearwater, FL, a maker of medical devices and supplies, has named Jay Ewers to the position of Chief Financial Officer.

Spinal Elements, Inc., Carlsbad, CA, a spine technology company, has named Paul Cory as Vice President of Sales.

Accuray Inc., Sunnyvale, CA, a radiation oncology company that develops, manufactures, and sells tumor treatment solutions has named Kelly Londy to serve as Chief Operating Officer.

Helius Medical Technologies, Inc., Newtown, PA, a company focused on the treatment of neurological symptoms caused by disease or trauma, has appointed Joyce LaViscount as Chief Financial Officer and Chief Operating Officer.

Graham Engineering Corporation, York, PA, a leader in industrial extrusion blow molding solutions, has appointed Steve Maxson to be the company’s Global Director of Business Development – Medical.

Pelican Products, Torrance, CA, a leading manufacturer of high-performance protective case solutions and advanced portable lighting systems, has appointed Rodney Davis as Director of Worldwide Environmental Health and Safety.

Expansions/Spinoffs/New Services/Moves

Infinity Medical Engineering, Cocoa, FL, which researches and develops diagnostic equipment and devices to prevent hospital-acquired infections, opens its 10,000-square-foot facility in Kissimmee, FL. Within the next five years, Infinity plans to build a 60,000-square-foot center in Kissimmee as its second phase of development.

RAUMEDIC, Helmbrechts, Germany, which provides tubing, precision moldings, and catheters as well as assemblies and systems for the medical industry, is building a new development and production center in Mills River, NC.

Diversified Plastics, Inc., Minneapolis, MN, has just finished building an environmentally controlled room for injection molding parts that require a cleaner-than-normal manufacturing environment, but not as clean as a certified clean room. The 1,800 square foot space will house one horizontal and two vertical injection molding machines with additional space for sonic welding and packaging.

Trelleborg Sealing Solutions, Fort Wayne, IN, has increased the size of its Product Testing Laboratory located at the HA Traub Technical Center in Fort Wayne. This expansion comprises a 1,000 square foot addition to the existing facility in order to accommodate the growing requests for product testing and validation.

Intelligrated, Mason, OH, a leading automated material handling solutions provider, announced the opening of a district office in Ontario, CA, as part of its Western regional sales and operations.


AtriCure, Inc., West Chester, OH, a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage management, has completed its previously announced acquisition of nContact, Inc., Morrisville, NC, a developer of cardiac ablation solutions.

Helius Medical Technologies Inc., Newtown, PA, focused on neurological wellness, has entered into strategic agreements with A&B Company Limited, Hong Kong,an investment and development company, for the development and commercialization of the Portable Neuromodulation Stimulator Therapy in China, Hong Kong, Macao, Taiwan, and Singapore.

Allergan plc, Dublin, Ireland, a global pharmaceutical company, has completed its acquisition of AqueSys, Inc., Aliso Viejo, CA, a devicemaker focused on the development of ocular implants that reduce intraocular pressure associated with glaucoma.

Lumenis Ltd., Yokneam, Israel, which makes energy-based medical devices for surgical, ophthalmological, and aesthetic applications, has signed a definitive agreement to be acquired by XIO Group, Hong Kong, an alternative investments firm.

CorVascular Diagnostics LLC, Minneapolis, MN, which provides diagnostic technologies to hospitals, clinics, and mobile testing centers, has entered into a collaboration and distribution agreement with Vasamed, Inc., Eden Prairie, MN, a manufacturer of hemodynamic health devices. CorVascular will act as exclusive distributor in the US hospital market of Vasamed’s PAD-IQ system, which measures tissue uptake of blood in the extremities.

The Greater Richmond Partnership, Richmond, VA, has announced the signing of a Memorandum of Understanding with Korea Medical Devices Industry Cooperative Association. The two organizations intend to establish a collaborative effort in the fields of medical research and development of medical devices and healthcare related technological advancements.

Humphrey Products, Kalamazoo, MI, a leading producer of pneumatic products, including valves and cylinders, a has recently acquired the Medical and Media Isolation Product Lines from the Curtiss-Wright Corporation, Charlotte, NC, a leader in innovation and advanced engineering technology. These products include liquid isolation valves, liquid isolation proportional valves, and a high resolution proportional control valve.

Valeant Pharmaceuticals International, Laval, Quebec, Canada, a multinational, specialty pharmaceutical company, has completed its acquisition of Synergetics USA, O’Fallon, MO, a supplier of precision surgical devices.

TriVascular Technologies, Santa Rosa, CA, a developer of technologies to advance minimally invasive treatment of abdominal aortic aneurysms, will merge with and become a wholly owned subsidiary of Endologix, Inc., Irvine, CA, a developer of minimally invasive treatments for aortic disorders.


Pasternack Enterprises, Inc., Irvine, CA, a leading provider of RF, microwave and millimeter wave components, has just launched its new mobile website  which provides a sleek, simplified and user-friendly interface that is specifically intended for smart phones and tablets.

Renesas Electronics America Inc., Santa Clara, CA,a premier supplier of advanced semiconductor solutions, announced a program designed to foster development of third-party software applications and services to support the Renesas Synergy™ Platform. Software vendors interested in participating in the program can visit  for more information.

Thomson Industries, Inc., Wood Dale, IL, a leading manufacturer of mechanical motion control solutions, has released a new educational video for design engineers, which provides step-by-step instructions on how to properly lubricate linear bearings and guides. To view the full video, please visit: .

Duke Extrusion, Santa Cruz, CA, an industry leading custom medical tubing manufacturer, has launched its new website at .

Jabil Circuit, Inc., St. Petersburg, FL, an electronic product solutions company providing comprehensive electronics design, production, and product management services to global electronics and technology companies, has received the 2015 Supply Chain Security Champion award from Cisco®.

AventaMed, Cork, Ireland, which has developed a hand-held pediatric ear tube device that does not require full general anesthesia, and Prospiria, Inc., Galveston, TX, which created a noninvasive device using optoacoustic imaging to monitor endotracheal tube positioning for pediatric life support patients, were selected to each receive a $50,000 award in the annual competition held by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. The competition fosters innovation to advance pediatric healthcare and address unmet surgical and medical device needs for children.