Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Boston Scientific, Marlborough, MA, a worldwide developer, manufacturer, and marketer of medical devices used in a range of interventional medical specialties, has received FDA approval for two catheters that can be used with the Rhythmia™ Mapping System. The IntellaNav™ XP and the IntellaNav MiFi™ XP navigation-enabled ablation catheters, designed to map and ablate, were approved to treat Type I atrial flutter.
Acutus Medical, Carlsbad, CA, a global heart rhythm technology company, has received CE Mark approval for its AcQMap™ High Resolution Imaging and Mapping System and AcQMap™ Catheter.
Senseonics, Inc., Germantown, MD, a medical technology company focused on the design, development and commercialization of glucose monitoring products, has received the CE Mark for its continuous Eversense continuous glucose monitoring system.
BIOTRONIK, Lake Oswego, OR, a leader in cardio- and endovascular medical technology, has received FDA approval of its Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans.
First Ray, Logan, UT, which is focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, has received FDA 510(k) clearance for its innovative Stealth Staple System, an intraosseous small bone fixation system.
Mobius Medical Systems, LP, Houston, TX,dedicated to provide modern software to theradiation oncology community, has received FDA clearance to market and accept orders for its new CBCT module in Mobius3D, the first of its kind online tool for evaluating patient positioning and patient anatomy changes.
Compliance West, San Diego, CA, a leading manufacturer of production and custom hipot and surge testers, announced that its HT-S family of hipots has earned the UL Listing Mark.
CareTaker Medical, Charlottesville, VA, a pioneer in wireless remote patient monitoring devices, has received FDA 510(k) approval for its Wireless Continuous Non-Invasive “Beat-by-Beat” Blood Pressure and Heart Rate Monitor that permits remote monitoring of patients’ blood pressure.
Toshiba Corporation, Tokyo, Japan, a world leader in advanced electronic and electrical products and systems, has promoted the chief of its medical equipment business, Satoshi Tsunakawa, to be its next CEO.
LEMO USA, Inc., Rohnert Park, CA, a leader in the design and manufacture of precision custom connection and cable solutions, announced that the company has appointed Farhad Kashani as General Manager.
Medtronic plc, Dublin, Ireland, one of the world's largest medical technology, services, and solutions companies, announced the appointment of Karen L. Parkhill as Executive Vice President and Chief Financial Officer, effective June 20, 2016.
SafeOp Surgical, Inc., Hunt Valley, MD, which has developed an FDA-approved neurological monitoring system, announced that Gene Cattarina will join the company as Chief Executive Officer.
GI Dynamics, Inc., Lexington, MA, which provides an innovative treatment for type 2 diabetes and obesity, announced the appointment of Jim Murphy to the position of Chief Financial Officer.
Corindus Vascular Robotics, Inc., Waltham, MA, a leading developer of precision vascular robotics, has added two staff members to its leadership team: Doug Teany as Senior Vice President of Research & Development and Operations, and Nora Dutta as Vice President, Human Resources.
Mary Lou Jepsen, the Executive Director of Engineering at Facebook, Menlo Park, CA, and the head of display technology at Facebook’s Oculus virtual reality division, has resigned in order to focus on miniaturizing MRI into consumable wearable technology that could be used to help cure diseases.
Davis-Standard, LLC, Pawcatuck, CT, a global leader in the design, development and distribution of extrusion and converting technology, announced the appointment of Scott Gardner as Regional Sales Manager for elastomer and profile systems.
EOS of North America Inc., Novi, MI, a global technology and quality leader for high-end solutions in additive manufacturing, opened its newest US facility in Pflugerville, TX, to provide increased service and support for the company’s growing North America market. The site includes an innovations laboratory, where EOS application engineers interact directly with customers, a working showroom, and a Ventures division to help bring start-up ideas to reality.
Sterigenics International LLC, Deerfield, IL, the leading global provider of contract sterilization, gamma technologies, and medical isotopes, has expanded its Wiesbaden, Germany, location to increase ethylene oxide processing capacity by 20 percent and allow for additional future capacity expansion of an additional 20 percent. Construction will be completed by Q1 2017.
Hexagon Manufacturing Intelligence, North Kingstown, RI, a leading metrology and manufacturing solution specialist,will hold a “HxGN LOCAL” Grand Opening at its newest Solution Center in Wilmington, DE, on May 19. The Wilmington Solution Center will offer training and customer support for local manufacturers in the Mid-Atlantic region.
DePuy Orthopaedics, West Chester, PA, part of the DePuy Synthes Companies of Johnson & Johnson and a global leader in orthopaedic devices and supplies, has acquired BioMedical Enterprises, Inc., San Antonio, TX, which manufactures Nitinol orthopedic implants for small bone fixation.
Stryker Corporation, Kalamazoo, MI, one of the world's leading medical technology companies, announced it has acquired Stanmore Implants Worldwide Limited, Elstree, UK, an innovative orthopaedic business focused on adult and juvenile orthopaedic oncology.
Greatbatch, Frisco, TX, a global developer and manufacturer of medical devices and components, has extended its licensing relationship with WiTricity, Watertown, MA, which provides technology to enable wireless power transfer using magnetic resonance, to leverage its wireless energy transfer technology in the development of implantable medical device applications.
Sinocare Inc., Changsha, China, a manufacturer of blood glucose monitoring systems, has agreed to acquire PTS Diagnostics, Indianapolis, IN, a maker of biometric testing devices. PTS is expected to become a wholly owned subsidiary of Sinocare.
PEI-Genesis, Philadelphia, PA, one of the world’s fastest assemblers of precision connectors and cable assemblies, has acquired Arizona-based FilConn, Inc, Chandler, AZ, a manufacturer of precision high reliability filter, transient suppression, and custom configured connectors for the milaero, medical, transit, and oil/gas industries.
BTG plc, London, UK, an international specialist healthcare company, has agreed to buy Galil Medical, Arden Hills, MN, which makes and sells cryoablation systems and needles, which inject compressed argon gas into the body to freeze tumors.
The Grünenthal Group, Aachen, Germany, a research-based pharmaceutical company, announced an exclusive license agreement with Adhesys Medical Inc., Houston, TX, the maker of surgical adhesives, for the distribution of an innovative topical skin adhesive in the EU and Latin America markets.
Ray Products Company Inc., Ontario, CA, now under its third generation of family ownership, marked its 67th anniversary last month. A plastics manufacturer offering custom 3D thermoformed plastic parts, Ray Products was one of the first thermoformers in the country to offer fully robotic trimming.
Teknor Apex Company, Pawtucket, RI, one of the world’s leading custom compounders, has unveiled its new website at www.teknorapex.com , which gives designers and processors access to extensive information on the company’s flexible and rigid PVC, thermoplastic elastomer, nylon, and flame retardant compounds, as well as color concentrates.
Bal Seal Engineering, Inc., Foothill Ranch, CA, a global provider of custom-engineered sealing, connecting, conducting, and EMI/RFI shielding and grounding solutions, has published a new technical catalog on how spring-energized seals can be used to address reciprocating and static/face sealing challenges. The catalog can be downloaded at www.balseal.com/technical-library.
Advanced Thermal Solutions, Inc., Norwood, MA, a global innovator in managing heat inside electronic devices, is now a corporate member of the PSMA–the Power Sources Manufacturers Association.
BIOCORP, Issoire, France, which specializes in the development and manufacturing of medical devices and drug delivery solutions, has won the European Product Line Strategy Leadership award granted by consulting firm Frost & Sullivan.