Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals and Launches
Covidien plc, Dublin, Ireland, a global medical device company, has received FDA clearance for its Fortrex over-the-wire percutaneous transluminal angioplasty balloon catheter designed to maintain arteriovenous access in patients undergoing hemodialysis. The company has also received the CE Mark for Nellcor Bedside SpO2 Patient Monitoring System, launching it in Europe, Australia, and New Zealand.
Vascular Solutions, Inc., Minneapolis, MN, an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures, has received FDA 510(k) clearance of its Turnpike catheters for use in complex coronary and peripheral procedures.
Royal Philips, The Netherlands, has received FDA 510(k) clearance for its IQon Spectral CT system, which can discriminate between X-ray photons of multiple high and low energies.
Etratech, Burlington, Canada, a designer, developer, and manufacturer of advanced electronic controls and control systems, has achieved ISO 13485:2003 certification for medical device manufacture.
Neuromod Devices, Dublin, Ireland, has received CE Mark approval in the European Union for its new multi-sensory device to treat tinnitus,
SuperSonic Imagine, Aix-en-Provence, France, which specializes in ultrasound medical imaging has received FDA 510(k) clearance for two new probes used with its ultrasound machine, the Aixplorer®.
ProMedica Health System, Toledo, OH, has launched a business incubator in a 6,000-square-foot facility at the organization’s Wildwood Medical Center Campus to nurture startups in the medical device and bioinformatics sectors.
Animas Corporation, Chesterbrook, PA, announced FDA approval of its Animas® Vibe insulin pump and Continuous Glucose Monitoring system to manage insulin-requiring diabetes in adults.
Benvenue Medical, Inc., Santa Clara, CA, a developer of minimally invasive solutions for spine repair, announced that it has received FDA 510(k) clearance for the company’s Luna® 360 Interbody Fusion System for spinal fusion treatment of symptomatic degenerative disc disease.
IPC’s Validation Services Program has awarded an IPC J-STD-001 and IPC-A-610 Qualified Manufacturers Listing to Sunburst Electronics, an electronics manufacturing services firm in Erie, PA.
Masimo Corporation, Irvine, CA, has obtained FDA 510(k) approval for its new wireless monitor, Radius-7, for the Root patient monitoring and connectivity platform.
Stimwave Technologies Incorporated, Miami Beach, FL, a medical device manufacturer and independent research institute, has received FDA clearance to market the world’s first wireless, microtechnology neuromodulation device for relief of chronic back and leg pain.
Sanmina Corporation, San Jose, CA, a leading integrated manufacturing solutions company making complex and innovative electronic, optical, and mechanical products, announced that its India Design Center has been awarded the ISO 13485:2003 and EN ISO 13485:2012 certifications for medical product design and development.
ArtVentive Medical Group, Inc., Carlsbad, CA, has received FDA clearance for its Endoluminal Occlusion System, designed for use in peripheral vasculature.
GI View Ltd., Ramat Gan, Israel, has received FDA 510(k) clearance for its Aer-O-Scope colonoscope system, and plans to launch it in the US market in early 2016. The device is the only colonoscope with a 360-degree omnidirectional view for colon cancer screening.
Leadership News
COR Medical Technologies, Houston, TX, which offers CORcare™, a comprehensive instant outcome support system for heart disease, announced that Dr. Brian Olshansky has joined its Senior Editorial Board, which reviews conditions and best practice treatments.
IntriCon Corporation, Arden Hills, MN, a designer, developer, manufacturer, and distributor of miniature and micro-miniature body-worn devices, has appointed Delain Wright to Vice President of Business Development, Value Hearing Health.
Helius Medical Technologies, Newtown, PA, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, announced the appointment of Dr. Jonathan Sackier as Chief Medical Officer.
PaR Systems, Inc., Shoreview, MN, a world leader in material handling, automation, and robotic solutions, announced the appointment of Danny Boman as West Coast Business Development Manager.
NinePoint Medical, Inc., Cambridge, MA, an emerging leader in the development of medical devices for advanced optical imaging, has appointed Christopher von Jako, PhD, as President and Chief Executive Officer.
Emerging medical device developers QuantuMDx, Newcastle, UK, received double honors when CSO Jonathan O’Halloran was named a “Pioneer” by Connected World for his Internet of Life vision, and CEO Elaine Warburton OBE was named a “BioBusiness Mover & Shaker” by BioBeat in a report on women bringing better health to people around the world.
Expansions/Spinoffs/New Services/Moves
Vascular Solutions, Inc., Minneapolis, MN, has completed the acquisition of its manufacturing facility, a 79,300-square-foot building in Maple Grove, MN. During 2015, the company intends to invest approximately $4.5 million in capital improvements to renovate the manufacturing facility to meet its growing manufacturing requirements.
Sekisui Plastics USA, Inc., Mount Pleasant, TN, has chosen Kenton, OH, as the location for its new $5.2 million manufacturing facility. Scheduled to come online next July, the plant will initially produce foam products molded mainly from Piocelan® hybrid moldable foam resin.
Mergers/Acquisitions/Collaborations/Licensing
Molex Incorporated, Lisle, IL, a leading global manufacturer of electronic solutions, has signed a definitive agreement as a strategic partner and investor in NuCurrent, Chicago, IL, a developer of wireless power antenna technology for the medical device market.
The European Commission has conditionally cleared the Medtronic, Inc., Minneapolis, MN, acquisition of Covidien plc, Dublin, Ireland. The decision is conditional on Medtronic's commitment to divest Covidien's drug-coated balloon business.
Autocam Medical Devices, LLC, Grand Rapids, MI, has acquired Southeastern Technology, Inc., Murfreesboro, TN, which manufactures precision-machined components, assemblies, and engineered solutions for medical device industry OEMs.
PneumRx, Inc., Mountain View, CA, which makes minimally invasive devices to treat emphysema, has been acquired by BTG Plc, London, UK, an international healthcare company active in interventional medicine and specialty pharmaceuticals.
Leica Biosystems, Buffalo Grove, IL, a global leader in anatomic pathology laboratory solutions and instruments, has acquired Devicor Medical Products, Inc., Cincinnati, OH, a market leader in breast biopsy instruments and consumables.
Miscellaneous
Mouser Electronics, Inc., Mansfield, TX, the global authorized distributor with the newest semiconductors and electronic components, announced the launch of its new Engineering Development Tools Center on www.Mouser.com , which will allow developers to select from a variety of development tools for products such as microcontrollers, analog and digital ICs, LED lighting, optoelectronics, wireless, and more.
