1. Articles in category: Other Business News

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    1. Avinger Announces Successful Treatment of First Patients Globally with Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      Avinger Announces Successful Treatment of First Patients Globally with Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD), today announced the successful treatment of the first nine patients with Pantheris SV (Small Vessel) at two separate hospitals in Germany. Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital Muenster and longtime innovator with Lumivascular technology, performed the first procedures globally. Additional cases were performed by Dr. Ulrich Sunderdiek, an interventional radiologist and cardiac surgeon at Marienhospital Osnabrueck. Pantheris SV was used to successfully treat a variety of lesion types ...

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    2. Avinger Provides Third Quarter 2018 Shareholder Update

      Avinger Provides Third Quarter 2018 Shareholder Update

      Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD), today reported results for the third quarter ended September 30, 2018. Third Quarter and Recent Highlights ● Achieved revenue of $2.0 million for the third quarter of 2018 ● Announced in September that physicians at 35 sites globally have successfully treated over 200 patients with the next-generation Pantheris image-guided atherectomy system ● Submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) in August for the Pantheris SV (Small Vessel ...

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      Mentions: Avinger
    3. NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE Imaging System

      NinePoint Medical Announces FDA Clearance of an Artificial Intelligence Software Upgrade for the NvisionVLE Imaging System

      NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its Intelligent Real-time Image Segmentation™ (IRIS) software upgrade for its flagship product, the NvisionVLE Imaging System. IRIS, an artificial intelligence-based platform for image feature segmentation, is the first tool of its kind approved for use in imaging of esophageal tissue. The NvisionVLE Imaging System allows physicians to perform a Volumetric Laser Endomicroscopy (VLE) procedure that produces real-time, high-resolution cross-sectional images. This system enables gastroenterologists to ...

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    4. Notal Vision Announces Appointment of Dr. Susan Orr as Chief Executive Officer

      Notal Vision Announces Appointment of Dr. Susan Orr as Chief Executive Officer

      Notal Vision, Ltd., a privately-held ophthalmic company focused on improving vision outcomes by extending ophthalmic diagnostic testing from the clinic to the home, has announced that after a long and successful period of growth and expansion, current Chief Executive Officer, Quinton Oswald , will retire at the end of this year. Susan Orr , OD, Chief Medical Officer and Vice President of Medical Affairs, has been appointed CEO, effective January 1, 2019 . Quinton Oswald will continue to serve on Notal's Board of Directors. Grace Chang , MD, PhD, recently joined Notal and will assume the role of Chief Medical Officer. "This leadership ...

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    5. Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System

      Conavi Medical and Japan Lifeline Advance Japanese Sales Strategy of Novasight Hybrid Intravascular Imaging System

      Conavi Medical Inc. is pleased to announce that Japan Lifeline has submitted an application for the regulatory approval of the Novasight Hybrid intravascular imaging system in Japan. In addition, Japan Lifeline will serve as the exclusive distributor of the Novasight Hybridintravascular imaging system in Japan. Novasight Hybrid is the world’s first system to have been used clinically that is capable of providing both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) on a single imaging catheter. Earlier this year, the Novasight Hybrid system received FDA 510(k) clearance in the United States and was featured by Conavi Medical at ...

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    6. Topcon Introduces Topcon Harmony and Triton Swept Source OCT at the 2018 American Academy of Ophthalmology (AAO) Annual Meeting

      Topcon Introduces Topcon Harmony and Triton Swept Source OCT at the 2018 American Academy of Ophthalmology (AAO) Annual Meeting

      Topcon is attending the 2018 American Academy of Ophthalmology (AAO) Annual Meeting in Chicago to demonstrate its latest innovative technology solutions for today’s ophthalmologists. AAO will mark the debut of Topcon Harmony, the next generation in ophthalmic data management. Harmony replaces Synergy and features a completely redesigned browser-based user interface that includes new features and vendor-neutral connectivity. John Trefethen, Vice President of Marketing & Product Design for Topcon, stated, “The last few months of hard work and preparation will be showcased at AAO starting on October 27 th . We are proud to demonstrate Topcon Harmony, the next generation of clinically ...

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    7. Optos and Amydis Establish Clinical Alliance to Develop Early Diagnostic Test for Alzheimer’s Disease

      Optos and Amydis Establish Clinical Alliance to Develop Early Diagnostic Test for Alzheimer’s Disease

      Optos Plc, a subsidiary of Nikon Corporation, Japan, and Amydis, Inc. today announced a clinical alliance focused on the development of an eye test by Amydis to detect Alzheimer’s disease. Amydis has developed a pipeline of compounds to detect amyloid proteins in the retina to be visualized with Optos’ market leading opto map® ultra-widefield retinal imaging devices to diagnose Alzheimer’s Disease in patients. Through this alliance, Optos and Amydis will collaborate on the clinical development of Amydis’ test for the detection of Alzheimer’s disease. The partnership will combine Optos’ market leadership with its proprietary ultra-widefield technology and ...

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    8. Topcon's Harmony imaging platform users in Europe now have access to IDx-DR

      Topcon's Harmony imaging platform users in Europe now have access to IDx-DR

      Topcon Healthcare Solutions (THS) announced today that it has partnered with IDx, a privately held AI diagnostics company, to expand the Harmony imaging platform to include IDx-DR, a state-of-the art AI system that detects diabetic retinopathy in digital fundus images, for its European customers. IDx-DR is the first AI-based diagnostic system with U.S. FDA clearance and a Class IIa CE mark for the autonomous detection of diabetic retinopathy, a complication of diabetes and a leading cause of blindness. In addition to being available as a stand-alone image-analysis solution, IDx-DR is now accessible in Europe via Topcon Harmony , THS’ solution ...

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    9. IDx and Topcon sign exclusive AI platform agreement for the U.S. market

      IDx and Topcon sign exclusive AI platform agreement for the U.S. market

      IDx , a leading AI diagnostics company, and Topcon, one of the world's leading ophthalmic device manufacturers, have signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market. The agreement grants exclusive rights to IDx in the U.S. as the only autonomous AI company permitted to sell its products with the Topcon NW400 – an easy to use, robotic fundus camera. Topcon continues to collaborate with other partners in the AI space for solutions that fall outside of this autonomous agreement. In turn, IDx has agreed to assign Topcon ...

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    10. Avinger Receives CE Marking Approval for Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      Avinger Receives CE Marking Approval for Pantheris SV, a New Image-Guided Atherectomy Device Designed to Treat Smaller Vessels

      vinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product line extension of the Lumivascular atherectomy system. CE Marking allows for distribution of Pantheris SV in the European Union (EU) and certain other countries that recognize the CE Marking. Pantheris SV is not available commercially in the United States at this time. Designed with a lower profile and longer length, Pantheris SV is intended to expand the addressable market for Pantheris by allowing physicians to treat lesions in smaller diameter ...

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      Mentions: Avinger
    11. Hamamatsu develops bright supercontinuum source

      Hamamatsu develops bright supercontinuum source

      Hamamatsu Photonics has developed a supercontinuum light source, also known the SC light source, that produces higher brightness – approximately 1000 times higher than the company’s own range of xenon lamps. At the same time, the SC source maintains the high stability equivalent to that of xenon lamps by optimizing output conditions and also using a high nonlinear optical fiber as its nonlinear optical material. This source is targeting the market for measuring the complex structure of semiconductor optical measurements. The company added that its official commercial release will be in the spring of 2019. The new SC light source ...

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    12. Altris.AI – The New Era of Retinal Diagnosis is Coming

      Altris.AI – The New Era of Retinal Diagnosis is Coming

      Altris.AI (Altris, Inc) announced it has signed an agreement with a South Korean ophthalmic and optical medical equipment manufacturer Huvitz Co., Ltd. aimed at the development of customized deep learning solutions for retinal diseases detection unique for Huvitz HOCT-1/1F device, All-in-One PC integrated 3D Optical Coherence Tomography (OCT) and Fundus Camera. Altris.AI’s OCT and Fundus algorithms have been trained using anonymized OCT retinal scans as well as Fundus images collected during more than 12 years, and are able to detect more than 50 retinal diseases and conditions. Currently, Altris.AI’s solution is available in web ...

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      Mentions: Huvitz
    13. Three Innovation Start-ups on the Move

      Three Innovation Start-ups on the Move

      Damae Medical working to diagnose skin tumors without a biopsy The start-up’s rapid and non-invasive technology is now in the pre-industrialization phase. Diagnosing skin cancer requires a biopsy, which is to say analyzing a patient’s tissue sample with a microscope. Damae Medical, which grew out of research conducted at the Laboratoire Charles-Fabry, 2 is aiming to revolutionize this exam. The technology developed by Damae Medical will provide dermatologists with an in vivo imaging modality that produces in-depth images of the tissue similar to histology without the need for skin tissue excision and processing. Co-founder and Chief Scientific Officer ...

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    14. Optovue Showcases World’s First OCT Angiography Metrics and Non-contact Method for Corneal Measurements at Vision Expo West

      Optovue Showcases World’s First OCT Angiography Metrics and Non-contact Method for Corneal Measurements at Vision Expo West

      Company Introduces Non-mydriatic Ophthalmic Camera Optovue, the global leader in the development of optical coherence tomography ( OCT ) and OCT angiography ( OCTA ), will showcase AngioAnalytics™, the world’s first OCTA blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness, and 3D PAR, its three-dimensional projection artifact removal software at Vision Expo West 2018. The company will also highlight its 9mm Epithelial Thickness Mapping (ETM), a wider version of its non-contact, quantitative method for corneal epithelia and stromal measurements, and debut its new non-mydriatic ophthalmic camera, Vivicon, offering a touch-screen tablet interface with fully automatic alignment and image ...

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      Mentions: Optovue Jay Wei FDA
    15. Heidelberg Engineering OCT Angiography Module Now Available in the United States

      Heidelberg Engineering OCT Angiography Module Now Available in the United States

      OCTA is a key component of the SPECTRALIS portfolio, delivering on the platform’s upgradeability and multimodal image capabilities. Heidelberg Engineering, a privately-held imaging solutions company focused on advanced diagnostic instruments and IT solutions for eye care professionals, announced today that it has received US Food and Drug Administration (FDA) clearance for its OCT Angiography Module (OCTA). The additional module is now available for new and existing SPECTRALIS® upgradeable diagnostic imaging devices. “We are excited to announce this FDA clearance as further validation not only of OCTA technology in the industry, but also of our commitment to meeting the highest ...

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    16. Avinger Announces Successful Treatment of 200th Patient with Next-Generation Pantheris Device

      Avinger Announces Successful Treatment of 200th Patient with Next-Generation Pantheris Device

      Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that physicians in 35 sites globally have successfully treated over 200 patients with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD). The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in late May 2018. The next-generation Pantheris device features a number of improvements intended to augment the performance and reliability of the design, including a simplified single balloon ...

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      Mentions: FDA Avinger
    17. Avinger Announces 510(k) Filing of Pantheris Small Vessel Device

      Avinger Announces 510(k) Filing of Pantheris Small Vessel Device

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system. Pantheris SV is a line extension of the Pantheris family of catheters, the first and only image-guided atherectomy devices for the treatment of PAD. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal ...

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      Mentions: Avinger
    18. Avinger Completes Enrollment in SCAN Clinical Study Comparings OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries

      Avinger Completes Enrollment in SCAN Clinical Study Comparings OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries

      Post-Market Study Compares Pantheris OCT Imaging with IVUS for Diagnostic Imaging in Peripheral Arteries Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that it has completed enrollment in the SCAN clinical study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. Avinger’s proprietary Lumivascular technology utilizes OCT to provide real-time vascular imaging for the diagnosis and treatment of peripheral artery disease. OCT is a light-based, high-definition imaging modality, which generates no X-ray radiation, and has a resolution approximately ...

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      Mentions: FDA Avinger
    19. Thorlabs Releases New MEMS‐VCSEL Swept‐Wavelength Laser Sources

      Thorlabs Releases New MEMS‐VCSEL Swept‐Wavelength Laser Sources

      Thorlabs announced today that it has released next‐generation versions of its 1300 nm MEMS‐VCSEL Swept‐Wavelength Laser Sources. With a record‐breaking coherence length of over 100 mm and sweep rates of either 100 kHz or 200 kHz, the SL131090 and SL132120 are the only commercially available MEMS‐VCSEL laser sources on the market. Based on a patented microelectromechanical system (MEMS) tunable vertical cavity surface emitting laser (VCSEL), these light sources include an active power control that maintains constant output power over the lifetime of the laser. All drive electronics and trigger signals needed to seamlessly integrate these ...

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      Mentions: Thorlabs
    20. Conavi Medical Announces Clinical Use of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

      Conavi Medical Announces Clinical Use of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

      Conavi TM Medical Inc. (www.conavi.com) is pleased to announce the first clinical use of the Novasight TM Hybrid System, which enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT). IVUS or OCT are typically used by interventional cardiologists to image coronary anatomy during minimally invasive procedures, such as angiograms, angioplasty and stenting procedures. Drs. Tej Sheth and Natalia Pinilla Echeverri are co-investigators at Hamilton General Hospital where the procedures were performed under a Health Canada Investigational Testing Authorization. The technology originated from Dr. Courtney’s laboratory at Sunnybrook Research Institute in ...

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    21. Axsun Technologies Announces Breakthrough Tunable VCSEL Platform for Optical Coherence Tomography (OCT) Imaging

      Axsun Technologies Announces Breakthrough Tunable VCSEL Platform for Optical Coherence Tomography (OCT) Imaging

      Axsun Technologies, Inc., a leading developer and supplier of MEMSbased optical engines for medical imaging, industrial spectroscopy, and optical telecommunications, today announced the development of a novel Tunable Vertical Cavity Surface Emitting Laser (Tunable VCSEL) platform for OCT imaging applications. Raising the bar on OCT imaging performance, Axsun’s new Tunable VCSEL platform leverages the company’s core strengths of high performance optical integration and cost-effective volume manufacturing. By integrating all the major tunable VCSEL components into a single compact butterfly package, the Axsun tunable VCSEL enables higher performance and flexibility, reliability and scalability with low power consumption. “While our ...

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    22. Heidelberg Engineering Prepares Leadership Team for the Future

      Heidelberg Engineering Prepares Leadership Team for the Future

      Heidelberg Engineering GmbH announced today changes to the leadership team responsible to consistently deliver the company’s brand promise of excellence and innovation, supported by knowledge and confidence. Having worked alongside the founders Dr. Gerhard Zinser and Christoph Schoess for over 23 years, Dr. Tilman Otto will continue to lead R&D. New to the leadership team, Ali Tafreshi who has served in sales, marketing and research capacities in both the US and German organizations for 6 years, will head up Product Management and Clinical Affairs. Dr. Gerhard Zinser carefully handpicked this powerful combination of technical and clinical talent to ...

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    23. Thorlabs Extends OCT Offering to Include 248 kHz A-Scan Rate Systems

      Thorlabs Extends OCT Offering to Include 248 kHz A-Scan Rate Systems

      Thorlabs announced today that it has expanded its well-established Ganymede™ OCT line to include two complete imaging systems offering an industry-leading A-scan rate of 248 kHz. With this new release, the GAN610C1 and GAN620C1 become the fastest commercially available Spectral-Domain OCT systems on the market, providing a new standard for high-speed, high-sensitivity 2D and 3D imaging of moving samples with reduced motion artifacts. As with Thorlabs’ previously released Ganymede™ and Telesto™ OCT systems, these new OCT systems are available in both general-purpose (GAN610) and high-resolution (GAN620 – 3 µm axial resolution) variants, each of which offers the same low roll-off and ...

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    24. Wasatch Photonics extends Cobra OCT spectrometer product line to shorter wavelengths and greater depths

      Wasatch Photonics extends Cobra OCT spectrometer product line to shorter wavelengths and greater depths

      Wasatch Photonics has expanded its flagship Cobra OCT spectrometer product line to include new models for 550 nm vis-OCT and long-range 800 nm OCT imaging , further extending the capabilities and application domains of OCT imaging. These two new variants of SD-OCT imaging access structural and functional information in wavelength ranges only accessible through cost-effective SD-OCT technology, and can deliver high resolution images at line scan rates up to 250 kHz. The new Cobra VIS models operate at visible wavelengths, leveraging the differential absorption of oxy- and deoxy-hemoglobin at 500-600 nm to provide depth-resolved, localized oxygenation mapping concurrently with the acquired ...

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