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November 21, 2016
Ascensia Diabetes Care Receives FDA Clearance for the CONTOUR NEXT ONE Blood Glucose Monitoring System
Ascensia Diabetes Care, a subsidiary of Panasonic Healthcare, announced that it has received U.S. Food and Drug Administration clearance for the CONTOUR NEXT ONE Blood Glucose Monitoring System (BGMS). This system features an easy-to-use blood glucose smart meter which links to a mobile device via Bluetooth connectivity. The meter connects to the CONTOUR DIABETES mobile app that collects, stores and analyzes patient blood glucose measurements delivered to it by the meter. The blood glucose measurements can be used to identify patterns and trends that may help patients understand how certain aspects of their daily activities affect their blood glucose.
The CONTOUR NEXT ONE System also features a smartLIGHT on the meter which provides instant feedback on blood glucose results, reminders and alerts to help support better management of diabetes. Additionally, the electronic logbook helps patients to record events such as meals, activities, and medication. Patients can also create a cloud-based account for management and storage of their data.
Neural Analytics Launches Lucid M1 Transcranial Doppler Ultrasound System
Neural Analytics announced the commercial launch of the Lucid M1 Transcranial Doppler Ultrasound System, a portable brain monitoring system designed to measure cerebral blood flow velocities within the head and neck. The system uses a type of ultrasound known as transcranial Doppler, which measures the speed of blood flow through the brain’s blood vessels. It does this by measuring the echoes of ultrasound waves traveling through the skull. Transcranial Doppler can help physicians diagnose brain disorders, potentially without requiring further, more invasive tests.
Neural Analytics also announced that the Company has joined the Society of Vascular and Interventional Neurology (SVIN) to support Mission 2020, an initiative to enhance global efforts to improve stroke care worldwide by significantly increasing stroke treatments for eligible patients and reducing global stroke disability. The EXPEDITE (Evaluate a NeXt Generation PortablE Diagnostic Platform for Determination and Immediate Triage of Emergency Large Vessel Stroke) Phase I clinical trial is underway, aiming to evaluate the Company’s portable monitoring platform for patients suffering an acute ischemic stroke. Top-line results from this study are expected to be available in 2017.
See more information on the Lucid M1 Transcranial Doppler Ultrasound System on Meddevicetracker.
Diazyme Laboratories Receives FDA 510(k) Clearance for Vitamin B12 Assay and Folate Assay
Diazyme announced that hat the U.S. Food and Drug Administration has granted 510(k) clearance to market its Vitamin B12 and Folate assays. Vitamin B12 and Folate perform important function in the body such as making normal red blood cells (RBCs), repairing tissues and cells, synthesizing DNA and keeping the nervous system healthy. Vitamin B12 and Folate Assays are indicated to test for levels of the two components in human serum, which can help diagnose the causes of anemia and neuropathy, assess nutritional status in patients, and monitor the effectiveness of treatment for vitamin B12 and folate deficiency. Diazyme also developed homogenous assays for both Vitamin B12 and Folate, these assays can be used with clinical chemistry analyzers in clinical laboratories. Diazyme submitted the 510(k) application in June 2016.
Spectranetics Corporation received CE Mark Approval for Stellarex 0.014” Drug Coated Balloon
Spectranetics Corporation announced that it has received CE Mark Approval for the Stellarex 0.014” Drug Coated Balloon, a newly developed product in addition to the Stellarex 0.035” Drug Coated Balloon. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease, and challenging critical limb ischemia (CLI) in patients. The combination of the currently available Stellarex 0.035” and the new 0.014” line available in Europe expands Spectranetics’ portfolio of DCBs to treat complex disease states across the lower extremities.
The Stellarex Drug Coated Balloon first received CE Mark Approval in January 2015. The 24 month results of the ILLUMENATE First-in-Human (FIH) study was used to support this regulatory approval. The results demonstrated a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3 percent. Additionally, the study showed 87.9 percent freedom from target lesion revascularization at 12 months and 85.8 percent at 24 months. Additional clinical studies are being conducted to evaluate the safety and efficacy of the Stellarex Drug Coated Balloon. Spectranetics recently presented positive data from the IDE ILLUMINATE Pivotal Study at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting. These results will be used to support U.S. FDA approval for the Stellarex Drug Coated Balloon. The Company has submitted its Pre-Market Approval (PMA) application earlier this November and is expecting to obtain approval during second half of 2017.
See more information on the Stellarex Drug Coated Balloon on Meddevicetracker.
Allergan announced that the U.S. Food and Drug Administration (FDA) has cleared the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The XEN Gel Stent is made of a permanent, soft, collagen-derived, gelatin. Upon implantation, it creates a diffuse outflow of aqueous from the anterior chamber into the non-dissected tissue of the subconjunctival space. The XEN Glaucoma Treatment System reduces intraocular pressure (IOP) in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. XEN is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.
Allergan also released data from the U.S pivotal trial that were used to support this regulatory submission. The results demonstrated that XEN can effectively lower IOP. Studies have shown that at 12 months using XEN, patients used, on average, less IOP lowering drops than they did before XEN was implanted. Allergan plans to launch the XEN Glaucoma Treatment System in the U.S. in early 2017.
See more information on the XEN Gel Stent on Meddevicetracker.
Amedica Corporation Receives FDA Clearance for the Taurus Pedicle Screw System
Amedica announced that it has received FDA clearance to commercialize the Taurus Pedicle Screw System. The Company is planning a full market launch for this system by the end of the year. The Taurus Pedicle Screw System is a modular degenerative system that increases intra-operative flexibility. The modular screw can be attached in-situ allowing for screw to screw distraction that improves disc space visualization. The modular head pull off strength rivals that of top loading screws, but can easily be assembled prior to insertion if desired. The dual-lead screw enhances insertion speed and increases pullout strength. Additionally, the tension headbody holds its position at any angle, and the patented helical flange design eliminates head splay and cross threading.
See more information on the Taurus Pedicle Screw System on Meddevicetracker.
Bracco SpA announced that it has launched the CT Exprès 3D Contrast Media Delivery System in the United States. CT Exprès is a multi-dose, multi-patient, syringe-less injector for computed tomography. The system consists of an injector unit, main and remote control panels, hand switch, bottle insulator and Floor Stand. The CT Exprès 3D Contrast Media Delivery System is designed to streamline workflow and optimize patient care within the CT department. This technology was cleared by the U.S. Food and Drug Administration in January 2016 for controlled automatic administration on the venous side, of contrast media and saline. CT Exprès is used in combination with Isovue (lopamidol injection) Imaging Bulk Package (IBP) and saline (0.9% Sodium Chloride Injection USP). Use of saline with this innovative contrast medium injector allows multi-dosing from a saline container.
See more information on the CT Exprès System on Meddevicetracker.
NeoVasc Receives Regulatory Approval for CE Mark Study
NeoVasc announced that it has received both regulatory and ethics committee approval to initiate the Tiara Transcatheter Mitral Valve Replacement Study (TIARA II) in Italy. The Tiara System is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach and is designed to replace the diseased native mitral valve without the need for open-heart surgery or use of a cardiac bypass machine.
TIARA II is a 115 patient, non-randomized, prospective clinical study evaluating the safety and performance of the Tiara Transcatheter Mitral Valve with the Tiara Transapical Delivery System. Data from this study will be used to file for CE Mark approval for this technology. The Company is expecting the first enrollment early in the new year, along with approvals in additional geographies in the first quarter of 2017.
See more information on the Tiara System on Meddevicetracker.
Medtronic announced that it has received CE Mark Approval for its HVAD System left ventricular assist device (LVAD) to be used for less-invasive implant procedure in patients with advanced heart failure. The HVAD System is the only centrifugal LVAD approved in the European Union for implantation via this new thoracotomy procedure. The new implant approach uses smaller incision, which helps to lessen surgical bleeding and related blood transfusions, as well as to reduce the development of right heart failure and result in short hospital stays. The thoracotomy implantation technique allows the area around the heart to remain largely intact, potentially preserving the sternum for future procedures or a heart transplant.
The HVAD System features the HVAD Pump which enables implantation through a small, lateral thoracotomy incision between a patient's ribs on the left side of the chest. An IDE Study to evaluate the new thoracotomy implantation technique is underway in Canada and the U.S. The study includes patients with end-stage heart failure who have not responded to standard medical management and who are eligible for heart transplantation.
See more information on the HeartWare Ventricular Assist System on Meddevicetracker.
Quidel Receives FDA 510(k) Clearance for the Solana HSV 1+2/VZV Assay
Quidel announced that it has received FDA 510(k) Clearance for the Solana HSV-1+2/VZV Assay. This assay is indicated for the qualitative detection and differentiation of Herpes Simplex Virus type I, Herpes Simplex Virus type II, and Varicella-Zoster Virus. DNA is isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active Herpes Simplex Virus I, Herpes Simplex Virus II and/or Varicella-Zoster infection.
The Solana HSV-1+2/VZV Assay is a molecular diagnostic test that is compatible with many transport media. It does not require upfront DNA extraction and it can generate three results in less than an hour. Additionally, Solana can process up to 12 patient samples in each run. The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue molecular product line to generate a fast and accurate test result.
See more information on the Solana HSV 1+2/VZV Assay on Meddevicetracker.
Abbott Laboratories Receives CE Mark Approval for the i-STAT Alinity System
Abbott Laboratories announced that it has received CE Mark Approval for the i-STAT Alinity System. It is now available in Europe and other countries that recognize CE Mark. The i-STAT Alinity System is a handheld blood testing platform that performs and analyzes menu of blood tests, ranging from blood chemistries to cardiac markers, using two to three drops of the person’s blood. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes to 10 minutes. It is able to do this by interacting with the i-STAT cartridge, which contains test reagents, to move fluid across the biosensors. The i-STAT Alinity System received FDA 510(k) clearance in July 2016 and Abbott is expecting to launch this device in early 2017.
See more information on the i-STAT Alinity System on Meddevicetracker
Qiagen announced the European launch of the newly CE marked CALR (Calreticulin) Mutation Assay. This assay is intended for the detection of CALR mutations in genomic DNA from subjects suspected of myeloproliferative neoplasms (MPN). It enables identification of the two majors CALR mutations, Type 1 and Type 2, and detects additional mutations in the CALR exon 9 region. The ipsogen CALR assay simplifies CALR testing by covering various relevant mutations in a real-time PCR-based assay to deliver multiple clinical results in less than a working day. The CALR Mutation Assay can be analyzed on two Qiagen’s platforms: QIAsymphony and Rotor-Gene (RGQ) platforms.
This assay is the latest addition to QIAGEN’s ipsogen portfolio of assays for both common and rare leukemia types. MPN include polycythemia vera (PV), essentialthrombocythemia (ET) and various forms of (primary) myelofibrosis (PMF).
See more information on the CALR Mutation Assay on Meddevicetracker.
Meddevicetracker: medical device intelligence and forecasts
What were the outcomes of critical catalysts featured in Meddevicetracker’s Q3 2019 Outlook Report? Find out in the Catalyst Roundup: A Review of Select Catalysts from Last Quarter’s Outlook Report. This data-rich graphic is available now – for free.
Topics Drug approval
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