Here is the latest batch of news from the medical products community.
Regulatory Approvals, Standards, and Launches
Compliance West, San Diego, CA, a leading manufacturer of production and custom hipot and surge testers, announced that its HT-S Family has earned the UL listing. The S series, available as an AC only, DC only, or AC/DC combination tester, is a long lasting, easy to use solution to production line hipot testing.
Auris Surgical Robotics, Inc., San Carlos, CA, as surgical robotics technology company, has received FDA clearance for its ARES (Auris Robotic Endoscopy System), a robotic endoscopy system to visualize and treat lung conditions.
SeaSpine Holdings Corporation, Carlsbad, CA, a global medical technology company focused on surgical solutions to treat spinal disorders, announced the full commercial launch of its Hollywood™ VI NanoMetalene® transforaminal lumbar interbody fusion device.
Biotronik, Berlin, Germany, global leader in cardio- and endovascular medical technology,
has launched its Solia S ProMRI 5.6 Fr lead, making it the smallest magnetic resonance imaging conditional pacing lead available in the US.
REBIScan, Inc., Boston, MA, a developer of advanced ocular scanning devices, announced that the FDA has awarded market clearance through the “de novo” pathway to its Pediatric Vision Scanner, a handheld device designed to help physicians screen for amblyopia.
SpineGuard, Paris, France, which develops and markets disposable medical devices to simplify surgeries, has received FDA 510(k) clearance for its new PediGuard Threaded Dynamic Surgical Guidance device, which may be used for pedicle screw insertion.
Biotricity, Inc., Redwood City, CA, a medical diagnostic and consumer healthcare technology company, has filed for an FDA 510(k) for its flagship product, which combines a proprietary mobile ECG monitoring device and an ECG viewer software package.
Polyganics, Groningen, The Netherlands, a medical technology company focused on the commercializing products and technologies for peripheral nerve reconstruction and regeneration, has received the CE Mark for NEUROCAP®, its nerve capping device, and plans to launch the product in Europe later this year.
Lombard Medical, Inc., Irvine, CA, which is focused on endovascular aneurysm repair of abdominal aortic aneurysms, announced that it has received CE Mark approval for its IntelliFlex™ Low Profile Delivery System for the Aorfix™ Endovascular Stent Graft.
Leadership News
Verily Life Sciences, Mountain View, CA, a division of Alphabet, Inc., has hired Carolyn Wang as the company’s chief communications officer.
Nordson Corp., Westlake, OH, which engineers, manufactures, and markets products and systems used for dispensing adhesives, coatings, sealants, biomaterials, polymers, plastics and other materials, has named Thomas Ebeling to be Director of Engineering and Operations for Extrusion and Coating Dies.
Cogentix Medical, Inc., Minneapolis, MN, a global medical device company serving the urology and airway management markets, announced that Brett A. Reynolds has rejoined the company as Senior Vice President, Chief Financial Officer and Treasurer.
CTL Medical Corporation, Dallas, TX, a medical device manufacturing and service company, which recently moved into a new 25,000-square foot facility to serve the spine surgery hub in North Texas, has announced its new executive management team. Danny Chon serves as the President and CEO; Fiona Lazarow as Chief Financial Officer; Sean Suh as Chief Technology Officer; Andy Choi as Chief Business Development Officer; Dean Fulford as the Vice President of Sales for the northern region; Lanny Duyck as the Vice President of Sales for the southern region; Jon Suh as the Vice President of Research and Development; Rose Moore as the Vice President of Business Development and Marketing; Otis Blackwell as the Vice President of Manufacturing; Sterling Thomason serves as the Director of Operations; and Tosan Onosode as Regulatory Affairs Specialist.
Breathtec BioMedical, Inc., Vancouver, BC, Canada, a medical diagnostics company focused on developing, in-licensing, and commercializing breath analysis devices to detect infections and diseases, announced the appointment of Guy LaTorre as Chief Executive Officer.
Plexus Technology Group, LLC, Jackson, MI, a provider of anesthesia information management systems, has appointed Joseph P. Gentile as Senior Vice President of Sales.
Dymax Corporation, Torrington, CT, announced the appointment of Marco Reyes as the Senior Regional Sales Manager- West.
Mack Molding, Arlington, VT, a leading custom plastics molder and supplier of contract manufacturing services, announced that Jonathan Whitney has been promoted to Director of Business Development.
Expansions/Spinoffs/New Services/Moves
Teleflex Medical OEM, Gurnee, IL, a global leader in diagnostic and interventional catheters, announced the opening of its Customer Solution Centre, in Limerick, Ireland. The facility has concept development rooms, an engineering area, a video conferencing center, and laboratories for 3D printing, prototype development, and device testing.
Davis-Standard, LLC, Pawcatuck, CT, the leading manufacturer of extrusion machinery in North America, is expanding its primary facility at its headquarters in Pawcatuck, adding 15,000 square feet of manufacturing space and more than 30 jobs over the next two years. The facility will house the manufacturing and precision machining of advanced multi-layer blown film dies.
Boston Scientific Corp., Marlborough, MA, a global medical technology leader, plans to make its Gurgaon, India, facility its biggest R&D hub outside the US, as it plans to develop devices such as stents, catheters, and pacemakers there for its Asia Pacific, Middle East, and African markets. The company plans to roll out products from this facility by 2017.
Dexcom, Inc., San Diego, CA, which is developing and marketing continuous glucose monitoring products and tools, is opening a 216,000-square-foot manufacturing facility in Mesa, AZ, that is expected to create up to 500 jobs.
Joerns Healthcare, Charlotte, NC, a vertically integrated designer, manufacturer, and distributor of post-acute healthcare products, recently announced that it added 45 positions to its corporate office in Charlotte in response to the company's recent growth.
Mergers/Acquisitions/Collaborations/Licensing
Zimmer Biomet, Warsaw, IN, which designs, manufactures, and markets orthopaedic reconstructive products, has closed on its acquisition of Compression Therapy Products, Eatontown, NJ, which makes non-invasive devices designed to prevent deep-vein thrombosis.
Terumo Corporation, Tokyo, Japan, a leader in cardiovascular technology, has entered into an agreement to purchase Sequent Medical, Inc., Aliso Viejo, CA, which is developing a new medical device for aneurysm embolization.
ITTIA, Bellevue, WA, a leading provider of fast, high performance database products and tools, and Micrium, Inc., Weston, FL, a real-time operating system provider for embedded systems and the Internet of Things, today announced the integration of ITTIA DB SQL and µC/OS RTOS, delivering high-performance data processing for mission-critical applications.
Photo Research Inc., Chatsworth, CA, a leader in light and color measurement solutions, has merged with its Novanta sister company JADAK, Syracuse, NY, a manufacturer of machine vision, radio-frequency identification, and bar code products for the health care and life science industries.
Henkel, Rocky Hill, CT, a leading manufacturer of adhesives, sealants, and functional coatings, is partnering with TerraCycle, Trenton, NJ, a global leader in recycling hard-to-recycle waste, to become the first company to offer a recycling solution for anaerobic adhesives. Through its Adhesive Recycling Program, Henkel customers can purchase a postage-paid recycling box that they can fill with empty adhesive containers and send to TerraCycle, which will thermally treat the containers and turn them into new plastic products.
Miscellaneous
KOA Speer Electronics, Inc., Bradford, PA, announced that it was presented with an Arrow Electronics Perfect Order Index award for 2015. KOA Speer received the platinum award which recognizes suppliers that achieve best-in-class performance for delivering perfect orders as measured by Arrow's eight-point measurement system.
Averna, Montreal, Canada, an industry-leading developer of test solutions and services for communications and electronics device-makers worldwide, has received Frost & Sullivan’s 2016 Global Leadership Award for its RP-6100 Series RF Record & Playback solution.
Cardica, Redwood City, CA, a manufacturer of minimally invasive stapling devices, has changed its name to Dextera Surgical to reflect the company’s expanded focus across a range of clinical procedures.
Parmatech Corporation, Petaluma, CA, was a winner of the 2016 Powder Metallurgy Design Excellence Awards Competition, sponsored by the Metal Powder Industries Federation, for four stainless steel MIM components—an articulation lock bar, articulation connector, articulation drive block, and knife guide—used in an articulating endoscopic surgical device designed specifically for thoracic surgery. An Award of Distinction in the Medical/Dental Category went to Flomet, LLC, an ARC Group Worldwide Company, DeLand, FL, for a MIM tungsten electrode used in a surgical ablation device that uses high temperature for the removal of tissue. Another Award of Distinction in the Medical/Dental Category was given to Advanced Forming Technology, an ARC Group Worldwide Company, Longmont, CA, for a MIM wedge blank used in an endoscopic staple gun.
