October 16, 2017
Abbott Launches Proclaim DRG Neurostimulator System
Abbott announced the U.S. launch of the company's Proclaim DRG Neurostimulator System, a new device designed to deliver stimulation to the dorsal root ganglion (DRG) and alleviate pain in patients suffering from complex regional pain syndrome (CRPS) of the lower limbs.
Using Bluetooth wireless technology, iOS software and a more intuitive Apple iPod touch mobile digital device as the system's controller, the Proclaim DRG system is designed to provide patients new benefits over traditional neurostimulation systems. The Proclaim DRG platform is magnetic resonance (MR)-conditional and recharge-free, offering upgradeability and increased battery capacity over Abbott's previous generation systems. To provide the most user-friendly experience, the Proclaim DRG Neurostimulator System also utilizes an iPod touch mobile digital device as the system's patient controller communicates wirelessly via Bluetooth wireless technology.
See more information Proclaim DRG on Meddevicetracker.
Oncomine DX Target Test Receives Positive Coverage Decision from Regence BlueCross/BlueShield
Thermo Fisher Scientific announced its Oncomine Dx Target Test has received a positive coverage decision by Regence BlueCross/BlueShield. The declaration makes the next-generation sequencing (NGS)-based companion diagnostic for non-small cell lung cancer (NSCLC) available to members in four states.
Regence BlueCross/BlueShield coverage of the Oncomine Dx Target Test, which simultaneously evaluates 23 genes clinically associated with NSCLC, will be in effect in Oregon, Idaho, Utah and select counties of Washington. With this test, physicians can match patients to U.S. Food and Drug Administration (FDA)-approved therapies in days instead of several weeks, which it often takes when screening samples one biomarker at a time.
See more information Oncomine Dx Target Test on Meddevicetracker.
ReWalk Completes Critical Design Review Processes of Restore System
ReWalk Robotics announced completion of all internal processes to initiate clinical studies and the initial production of its "soft suit" exoskeleton design for stroke patients. Called "Restore," the new system transmits power to key joints of the legs with cable technologies, powered with software and mechanics that are similar to the technologies used in the ReWalk exoskeleton system for individuals with spinal cord injury. The cables are connected to fabric-based designs that attach to the legs and foot, thus lending the name "soft suit." This design is targeted to serve the stroke rehabilitation community.
Anticipated delivery of a commercial Restore soft suit is targeted for 2018. ReWalk plans to commercialize use of the Restore system in Europe and the United States after receiving CE and FDA clearance, respectively, to market the device. The company intends to apply for CE and FDA clearances in mid-2018; CE and FDA clearance applications will be submitted as clinical and laboratory testing are completed in the coming months.
See more information ReWalk Soft Suit on Meddevicetracker.
October 17, 2017
Viveve Medical Receives Approval in Mexico for Viveve System
Viveve Medical announced that it has received approval from the Mexican Regulatory Authority, COFEPRIS, to market the Viveve System in Mexico for treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function.
Regulatory approvals and clearances for the Viveve System for treatment of vaginal laxity or improvement in sexual function have been received from more than 50 countries. Viveve is also working to submit an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) to conduct a pivotal study on the use of the Viveve System for improvement in sexual function in women.
See more information the Viveve System on Meddevicetracker.
Adventist Health System Partners with Glytec to Enhance Diabetes Care
Adventist Health System has partnered with Glytec to implement the eGlycemic Management System (eGMS) at 39 of its acute care facilities. Glytec’s cloud-hosted eGMS will contribute to the standardization of care for patients who undergo insulin therapy, whether in an intensive or critical care unit or on a medical-surgical floor. eGMS centers on Glucommander, an FDA-cleared insulin dosing solution that supports intravenous and subcutaneous therapy as well as transitions. eGMS also includes hyperglycemia surveillance, glycemic status monitoring, robust analytics and reporting, and hospital-to-home planning.
In addition to utilizing eGMS, Adventist Health System will collaborate with Glytec on new studies that examine the impacts of various glycemic management initiatives.
See more information the Glucommander on Meddevicetracker.
October 18, 2017
OptiScan Receives FDA Approval for Inline Continuous Glucose Monitor
OptiScan Biomedical announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the OptiScanner 5000 Glucose Monitoring System. The clearance allows the device to be used for monitoring plasma glucose levels and determining dysglycemia in surgical intensive care unit (SICU) patients. The OptiScanner 5000 is the first-of-its-kind automated, bedside glucose monitoring system that provides physicians with critical trending and tracking information to manage patient glucose levels in the ICU.
The clearance by FDA was based on results from OptiScan's pivotal, multi-center clinical trial in 160 surgical intensive care unit patients comparing the accuracy of the OptiScanner 5000 to industry standard glucose measurement in the ICU. Results from the study demonstrated the OptiScanner 5000 to be safe and accurate for use in patients in the surgical intensive care unit.
See more information on the OptiScanner 5000 on Meddevicetracker.
NuVasive Launches New 3D-Printed Porous Titanium Implant
NuVasive announced the launch of Modulus XLIF titanium implants. The new 3D-printed, fully porous device provides a differentiated offering for the Company’s flagship XLIF procedure.
The new Modulus titanium implants are developed using additive manufacturing technology, or 3D printing, to create an organic, porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding. By employing microporous surface topography, Modulus XLIF creates an ideal environment for bone in-growth. The device’s architecture also leads to improved imaging characteristics compared to traditional titanium interbody devices.
See more information on Modulus XLIF Interbody System on Meddevicetracker.
Dario Health Receives CE Mark for iPhone 7/8 Smart Glucose Meter
DarioHealth announced that it received the CE Mark for its Lightning-enabled version of the Dario Blood Glucose Monitoring System. This ensures that consumers, beginning in the UK market, will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8.
With this announcement, DarioHealth can now successfully offer its proprietary meter with either a 3.5mm headphone jack or Lightning connector.
See more information on Dario Smart Meter on Meddevicetracker.
October 19, 2017
Vectura Announces Launch of Seebri Neohaler
Vectura Group confirms that Sunovion Pharmaceuticals, the US licensee of the Group's partner Novartis, has launched the twice-daily long acting muscarinic inhibitor (LAMA) Seebri Neohaler (glycopyrrolate 15.6mcg), in the US.
Sunovion entered into an exclusive license agreement with Novartis for the US commercialization rights to three of Novartis' COPD treatments, including Seebri Neohaler and Utibron Neohaler, in December 2016, and in April 2017 Sunovion confirmed it had launched the dual long acting bronchodilator and muscarinic combination therapy (LABA-LAMA) Utibron Neohaler, in the US.
See more information on the Neohaler Inhaler on Meddevicetracker.
October 20, 2017
Woulgan Biogel to be listed on UK Drug Tariff
Biotec Pharmacon’s wholly owned subsidiary Biotec BetaGlucans has received feedback from the NHS that Woulgan will be listed on the UK Drug Tariff from January 2018.
This gives Woulgan access to a major European market. It is also a strong signal to other markets because an objective analysis has concluded that Woulgan is not only clinically effective, but also cost effective in the treatment of challenging wounds. The company will now focus its efforts on a successful launch in January 2018.
See more information on the Woulgan Biogel on Meddevicetracker.