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February 27, 2017
BTG announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for material enhancements and expanded indications of the EkoSonic Endovascular System. The newly cleared system, recognized as the EKOS Control Unit 4.0, comprises an ultrasonic device that uses acoustic pulses to quickly and safely dissolve blood clots and restore blood flow in patients with pulmonary embolism (PE), deep vein thrombosis (DVT), and peripheral arterial occlusions (PAO) – disorder more aptly known as peripheral arterial disease (PAD). Previously, the device had been cleared in the United States and Europe for infusions of physician specified fluids, including thrombolytics, into the peripheral vasculature and pulmonary arteries for the treatment of only DVT and PE. With this additional clearance however, in conjunction with a pending product launch in the United States expected to occur before the end of spring 2017, BTG seems bullish to further solidify its leadership position in the vascular disease market.
See more on the EkoSonic Endovascular System on Meddevicetracker.
ViewRay announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the MRIdian Linac System, the company’s next generation linear accelerator-based magnetic resonance imaging (MRI) guided radiation therapy system. The MRIdian system, a single medical device designed to permit imaging of cancer patients at the radiotherapy isocenter before and during treatment, had previously been granted its first set of clearances in the United States in 2012, Europe in 2014, and China in 2016. Since then, however, ViewRay has made the decision to swap the device’s cobalt build with linear accelerator (Linac) technology, a material that the company claims to be more enhancing to the device’s imaging capabilities, as well as more economical – leaving more room for profit. This approval is therefore a significant milestone for ViewRay’s continued success, as it can anticipate the U.S. product launch and subsequent pending approval in China, which investors can currently expect to occur by the end of June 2016.
See more on the MRIdian System on Meddevicetracker.
February 28, 2017
RepliCel announced that it has signed agreements with two European firms, AMI and Art of Technology, to ensure the Company’s first fully functional prototype of its second generation dermal injector device, RCI-02, is manufactured and tested by the end of summer 2017. RCI-02, which was recently granted two patents in Europe, has been designed to provide improved levels of control and precision for dermatology injections, delivering substances into specific layers of skin and muscle tissue in a slow and steady form without any pressure or shear stress – a problem commonly associated with other dermatology injectors. As AMI and Art of Technology are two firms touted to possess a combined global distribution network and expertise in technical documentation control, RepliCel appears optimistic that it will meet its previously announced goal of a CE Mark filing to the European Union by the end of 2017, with expectations for an approval and subsequent product launch to occur soon thereafter in 2018.
See more on the RCI-02 Dermal Injector on Meddevicetracker.
Alphatec announced the Company is making positive progress with its new Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS) System, broadcasting the initiation of its limited launch in the United States and successful completion of several patient cases. As a significant expansion to the Company’s previously cleared Deformity Spinal Fixation System, the AIS system comprises a wide variety of low-profile implants that provide a better anatomical fit and increased ability to address patient pathologies, an ergonomic design for improved surgical efficiency and comfort, and increased biomechanical strength critical to achieving a solid fusion in pediatric patients. Provided the several benefits of this next-generation system, and proven clinical results from several case studies, Alphatec seems to be on-track to further expanding its already sizeable footprint in a deformity spine market that is estimated to be worth upwards of $650 million USD.
See more on the Deformity Spinal Fixation System on MeddeviceTracker.
CeloNova announced that its COBRA PzF Stent System has been granted Pre-Market (PMA) approval by the United States Food and Drug Administration (FDA) following the release of positive data from the Company’s pivotal PzF SHIELD clinical trial. The data, which successfully met its primary safety and efficacy endpoints at 9-month follow up, demonstrated no stent thrombosis and low clinically driven target revascularizations (TLR) of 4.6 percent. This approval, which the Company sees as a significant milestone for CeloNova, is the first approval received for the COBRA Stent in the United States, as the device has previously been approved in Europe under a CE Mark received in January 2012. CeloNova now claims that it will continue to study the stent system its recently initiated COBRA REDUCE trial, which began in February 2016. The randomized controlled trial aims to evaluate whether or not the COBRA PzF stent can reduce bleeding as compared to drug eluting stents, by shortening the duration of DAPT to 14 days in patients who are at high-risk for bleeding and require treatment for coronary artery lesion.
See more on the COBRA PzF Stent System on Meddevicetracker.
Sysmex Corporation announced that the cancer-related gene panel testing system it is jointly developing with the National Cancer Center Japan, has received its first designation under the Ministry of Health, Labour and Welfare’s Sakigake Designation System for in-vitro diagnostic pharmaceuticals. The system, which is being tested in a lab that the two companies opened in 2015, known as the Sysmex Cancer Innovation Laboratory (SCI-LAB), enables the simultaneous analysis of more than 100 types of genetic mutations, allowing for multiple gene mutations to be detected from specimens (cancer tissue) of patients for whom standard treatment (including treatment with anti-cancer drugs), has been concluded or is expected to conclude, supporting decisions on treatment methods once standard treatments have ended. The companies plan to use the System in the cancer diagnostic panel (NCC Oncopanel) that the National Cancer Center has developed for this research. As no other regulatory information about the device has been released by either company, there is no doubt that this new designation is a significant stepping stone for potential approval in the future.
See more on the cancer-related gene panel testing system on Meddevicetracker.
Volition announced that it has begun a two-part logistical study of the Nu.Q Colorectal Cancer (CRC) Screening Triage blood test in Denmark, which will aim to ensure the device is ready for a smooth national rollout in the future. The first phase of the study, which began this week, will involve up to 250 patients and is expected to be completed within the next two months. It will focus on evaluating the logistics in collecting and processing blood samples at a local screening center and subsequently shipping the samples to a central laboratory in Denmark to run the Nu.Q analysis. The second phase of the study, on the other hand, is expected to initiate after the Company is granted Ethical Approval to do so, which, per a communication with Volition, is anticipated to happen in either April or May. This final phase is expected to involve five centers and 500 subjects, and will specifically assess the time taken between blood collection, analysis and results. As the entire study is planned to complete within the next six months, it can be expected that volition is already anticipating a date to launch its national screening program with Nu.Q.
See more on the Nu.Q Assay on Meddevicetracker.
Tandem Diabetes announced the release of a software update for t:slim insulin pumps purchased prior to April 2015. The software update will be available via personal computer using the Tandem Device Updater, a Mac and PC-compatible tool for the remote deployment of Tandem insulin pump software. This represents the first time an insulin pump manufacturer has provided a software update for customers using their personal computer. This first-of-its-kind update represents an important advancement in the way functionality is delivered to insulin pump users, making it possible to provide new pump features to our customers independent of the typical pump insurance replacement cycle.
See more on t:slim on Meddevicetracker.
Intact Vascular announced that the first patient in its Pivotal TOBA II BTK clinical trial has received treatment at Yuma Regional Hospital and the Heart, Lung and Vascular Center in Yuma, Arizona. Treatment comes just weeks after announcing the initiation of the clinical trial aimed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). TOBA II BTK is the first known industry-sponsored pivotal clinical trial approved by the U.S. Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee, according to Intact Vascular. The study will be conducted at up to 50 global sites and will enroll 232 patients in total. Eligible patients will have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately following angioplasty. Intact Vascular is also sponsoring the TOBA II and TOBA III studies. TOBA II is investigating the combination of the Tack Endovascular System with both uncoated angioplasty balloons and the Bard Lutonix Drug-Coated Balloon in patients with superficial femoral and popliteal artery disease. TOBA III is investigating the combination of the Tack Endovascular System with the Medtronic In.Pact Admiral Drug-Coated Balloon in a similar population. With the positive progression of these pivotal trials, and a CE Mark already obtained for the device in earlier this year in January 2017, Intact Vascular seems on-track for positive regulatory decisions on its Tack Endovascular System in the foreseeable future.
See more on the Tack Endovascular System on Meddevicetracker.
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