Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Precision Spine, Inc., Parsippany, NJ, announced that it recently received 510(k) clearance and initiated the launch of its VAULT-C Anterior Cervical Interbody Fusion Device.
Konica Minolta Medical Imaging, Wayne, NJ,has received FDA approval for its AeroDR XE wireless imaging panel to be used for portable radiology and for use under ER and ICU conditions
Vesiflo, Inc., Redmond, WA, announced that its inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in women, has been cleared for marketing by the FDA.
lshemari Instruments, Charlotte, NC, announces the launch of its flagship medical device, the Alshemari Needle Driver, which allows surgeons to apply sutures vertically, in areas that would be difficult to reach with traditional drivers.
Dexcom, Inc., San Diego, CA, a leader in continuous glucose monitoring for patients with diabetes, has received FDA 510(k) approval for its Dexcom SHARE remote mobile communications device, which can transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients.
Medtronic, Inc., Minneapolis, MN, has introduced its Pure Titanium Coating platform of interbody fusion devices for the spine.
Zyno Medical, LLC, Natick, MA, has received FDA 510(k) clearance as well as the CE Mark for its ambulatory infusion system, which it will market under the trade name Nimbus™.
ReFlow Medical, San Clemente, CA, has received FDA clearance for its Wingman35 crossing catheter for use with steerable guidewires to access peripheral vasculature.
Flint Rehabilitation Devices, Irvine, CA, has launched its first product, the MusicGlove, a Class I hand rehabilitation device that uses music and games to help victims of stroke and other neurological and muscular injuries.
Graphene Frontiers LLC, Philadelphia, PA, a developer of graphene materials and device technology, was issued a key industry patent, “Methods and Apparatus for Transfer of Films among Substrates,” which covers the transfer of graphene films between surfaces using roll-to-roll manufacturing processes and could be used in medical diagnostics.
Leadership News
Varian Medical Systems, Inc., Palo Alto, CA, has appointed Laura Hafner as Director of Global Marketing for its Imaging Components Business.
MRPC, Butler, WI, a custom manufacturer of silicone, medical rubber, and thermoplastic components, has hired Corey Wentz as its West Coast Business Development Manager.
Intelligrated®, Cincinnati, OH, a leading North American-based automated material handling solutions provider, announces the appointment of Kevin Roach as Executive Vice President and General Manager of the Intelligrated software group.
Expansions/New Services/Moves
MedVenture Technology Corporation, Jeffersonville, IN, a medical device design and manufacturing company and part of Helix Medical LLC, has expanded its operations into Costa Rica. Helix Medical Costa Rica is now under the leadership of MedVenture as Helix Medical's Minimally Invasive Solutions division and focuses on assembly manufacturing of minimally invasive surgical and catheter-based devices.
Sil-Pro Medical Manufacturing Solutions, Delano, MN, has added 6,000 square feet of ISO Class 7 cleanroom space due to an increased demand for contract manufacturing/assembly applications and thermoplastic molding.
Georg Fischer LLC, Irvine, CA, and GF Machining Solutions LLC, Lincolnshire, IL, announced the opening of the GF Piping Systems and GF Machining Solutions' new 105,000 square foot Irvine, CA, facility.Its manufacturing/fabrication area is capable of producing 3,000 different kinds of valves assembled to specific customer requirements and can cut large pipe diameters up to 42" in size.
Sorin Group, Munich, Germany, a global medical device company, has expanded its Munich manufacturing facility to accommodate demand for its cardiopulmonary technology.
Mergers/Acquisitions/Collaborations/Licensing
STERIS Corporation, Mentor, OH, a leading provider of infection prevention products and services, will acquire Synergy Health, Swindon, UK, a global leader in outsourced sterilization services for medical device manufacturers, hospitals, and other industries.
Vancive Medical Technologies™, Chicago, IL, which creates pressure-sensitive adhesives for medical applications, and Aspen Medical Europe Ltd., Worcestershire, UK, a manufacturer and distributor of products for wound care, ophthalmic products, and surgical accessories, announced an agreement for the exclusive distribution of the Vancive BeneHold™ Absorbent Wound Dressing portfolio in the United Kingdom and Ireland.
The All India Institute of Medical Sciences, New Delhi, India, has signed a Memorandum of Understanding with Osaka University, Osaka, Japan, to work together to develop affordable medical devices.
Versatile Power, Inc., Campbell, CA, a technology leader in commercial power supplies and custom electronic subsystems, has appointed TRC Electronics, Montgomeryville, PA, to handle distribution of its BENCH Programmable DC Power Supplies.
Miscellaneous
Molex Incorporated, Lisle, IL, a leading global manufacturer of electronic solutions, has received the 2014 Award for Excellence in Technology Alignment from Cisco for demonstrating leadership and a commitment to continuously innovate and deliver leading-edge technology.
Phillips-Medisize Corporation, Hudson, WI, a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics and medical device, and specialty commercial markets, is marking its 50th anniversary of business operations.
Ensinger Inc., Nufringen, Germany, has named Victrex plc, West Cionshohocken, PA, the world’s leading manufacturer of high performance polyaryletherketones, as the winner of its High Performance Supplier/Partner of the Year award for 2013.
