1. Articles in category: Other Business News

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    1. 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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    2. 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
    3. 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
    4. 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
    5. 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
    6. 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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    7. 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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    8. 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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    9. 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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    10. 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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    11. NinePoint Medical Appoints Eman Namati, Ph.D., to Chief Executive Officer

      NinePoint Medical Appoints Eman Namati, Ph.D., to Chief Executive Officer

      NinePoint Medical, Inc, a transformative medical device company pioneering the use of Optical Coherence Tomography (OCT) for gastrointestinal applications, is pleased to announce the appointment of Eman Namati, Ph.D., to President and Chief Executive Officer. Dr. Namati succeeds Christopher von Jako, Ph.D., who will continue to serve on the Board of Directors as an independent member. Dr. Namati will assume day-to-day leadership at NinePoint Medical while working in collaboration with Merit Medical Systems Inc. (NASDAQ:MMSI), who now manages the sales distribution and customer service for the NvisionVLE®Imaging System. "With the recent strategic partnership NinePoint entered into ...

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    12. Axsun Technologies Reaches Shipment Milestone of 15,000 Swept Lasers for Optical Coherence Tomography (OCT) Imaging

      Axsun Technologies Reaches Shipment Milestone of 15,000 Swept Lasers for Optical Coherence Tomography (OCT) Imaging

      Axsun Technologies, Inc., the leading manufacturer of Swept Source Optical Coherence Tomography (SSOCT) engines, today announced that the company has shipped over 15,000 swept lasers for OCT imaging applications. “Axsun’s lasers for OCT imaging enable the highest performance systems in ophthalmology, vascular and other medical and industrial imaging applications,” explained Jonathan Hartmann, CEO of Axsun. “This significant milestone in our company’s history is a testament to Axsun’s technology leadership, the scalability of our manufacturing platform, and our incredible team. It is also an exciting milestone for our customers and the patients they serve with this leading ...

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    13. Dynatronics Announces Christopher von Jako, Ph.D. as New Chief Executive Officer

      Dynatronics Announces Christopher von Jako, Ph.D. as New Chief Executive Officer

      Dynatronics Corporation (NASDAQ: DYNT) announced today that the Company's Board of Directors has appointed Christopher R. von Jako, Ph.D., as Chief Executive Officer effective immediately. He assumes day-to-day leadership of the Company and also joins Dynatronics' Board of Directors. Dr. von Jako succeeds Kelvyn H. Cullimore, Jr., the Company's co-founder and previous CEO. Mr. Cullimore continues to serve on the Board of Directors as a non-employee director. "After thorough succession planning and a comprehensive search process, the Board is pleased to have found the best individual to assume leadership of this organization," said Erin S. Enright, Chairman ...

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    14. Perimeter Medical Imaging Inc Appoints Charles S. Carignan, MD as New CEO

      Perimeter Medical Imaging Inc Appoints Charles S. Carignan, MD as New CEO

      Perimeter Medical Imaging Inc., a developer of real time imaging systems for in-surgery tissue assessment, is pleased to announce the appointment of Charles S. Carignan, MD as CEO. Dr. Carignan has more than 20 years of experience in key leadership positions spanning the medical imaging, women’s health, surgery and rehabilitation sectors. He brings a proven track record of successfully commercializing a number of breakthrough technologies that dramatically improved healthcare for patients. Most recently he has served as CEO of REX Bionics, a developer of robotic rehabilitation systems designed for people with mobility impairments. As CEO of BionX Medical Technologies ...

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    15. Avinger Announces Successful Treatment of First Patients with Next-Generation Pantheris in Several Centers throughout the US

      Avinger Announces Successful Treatment of First Patients with Next-Generation Pantheris in Several Centers throughout the US

      Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that several physicians have successfully treated over 40 patients in the US across 13 sites with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD). This positive initial case experience in the US adds to the impressive clinical results achieved in the first 30 cases completed in Germany earlier this year and provides a strong foundation for expanded market launch into all US accounts. The next-generation Pantheris design includes a simplified single balloon system for cutter apposition and ...

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      Mentions: Avinger
    16. Avinger’s Ocelot Technology Featured in Live Case Transmission at Complex Cardiovascular Catheter Therapeutics (C3) 2018

      Avinger’s Ocelot Technology Featured in Live Case Transmission at Complex Cardiovascular Catheter Therapeutics (C3) 2018

      Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that its Ocelot image-guided chronic total occlusion (CTO) crossing device was featured in a live case on June 19 th at Complex Cardiovascular Catheter Therapeutics (C3) 2018 in Orlando, Florida. Ocelot combines real-time image guidance using optical coherence tomography (OCT) with a proprietary CTO crossing catheter design to aid physicians in the treatment of chronic total occlusions. Dr. Mahir Elder, an interventional cardiologist at the Detroit Medical Center Cardiovascular Institute, performed the case. The patient had previously undergone a failed attempt by another ...

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      Mentions: Avinger
    17. Avinger Announces First Patients Enrolled in Post-Market Study Comparing Pantheris OCT Imaging to Intravascular Ultrasound

      Avinger Announces First Patients Enrolled in Post-Market Study Comparing Pantheris OCT Imaging to Intravascular Ultrasound

      Avinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the initiation of the SCAN study, a post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. OCT is a light-based, high definition imaging modality, which generates no X-ray radiation. Avinger's proprietary Lumivascular technology utilizes OCT to provide real-time intravascular imaging during the treatment of peripheral artery disease. The Company's Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing catheters are the only catheters available worldwide that incorporate the ...

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      Mentions: FDA Avinger
    18. Optovue Announces Expanded FDA Clearance of Epithelial Thickness Mapping

      Optovue Announces Expanded FDA Clearance of Epithelial Thickness Mapping

      Optovue , the global leader in the development of optical coherence tomography ( OCT ) and OCT angiography ( OCTA ), today announced an expanded FDA 510(k) clearance for non-contact, quantitative measurements of the epithelial and stromal layers of the cornea, termed epithelial thickness mapping or ETM. The expanded clearance adds a nine-millimeter ETM scan to the previously available six-millimeter map, allowing for detection of epithelial irregularities in an area that is about two-and-a-quarter times that of the area covered by the six-millimeter scan. Optovue’s ETM, now available on the Avanti® Widefield OCT system, is the first and only FDA-cleared product indicated to ...

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    19. Optovue Receives FDA Clearance for AngioAnalytics – the World’s First OCT Angiography Metrics

      Optovue Receives FDA Clearance for AngioAnalytics – the World’s First OCT Angiography Metrics

      Optovue announced FDA 510(k) clearance of AngioAnalytics™, the world’s first optical coherence tomography angiography (OCTA) blood vessel measurement technology to help clinicians manage diseases that cause progressive blindness. The company also received clearance for its three-dimensional projection artifact removal (3D PAR) software, which greatly improves OCTA image quality and enables accurate measurement and interpretation of OCTA images. AngioAnalytics and 3D PAR are commercially available in the U.S. “AngioAnalytics and 3D PAR are game changers because they 'erase' overlying inner retinal blood vessel artifacts allowing for better visualization and more accurate measurement of the outer retina and choroidal ...

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      Mentions: Optovue Jay Wei FDA
    20. PhotoniCare Receives $2.1 Million National Institute of Health Phase IIb Small Business Innovation Research Award

      PhotoniCare Receives $2.1 Million National Institute of Health Phase IIb Small Business Innovation Research Award

      PhotoniCare, a medical device company headquartered in Champaign, Illinois, received a $2.1 million award through the National Institute of Health (NIH) Phase llb Small Business Innovation Research (SBIR) program. The National Institute of Deafness & Communications Disorders (NIDCD), part of the NIH, is funding this award. The NIDCD conducts and supports research in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. In fiscal years 2015 and 2016 PhotoniCare was awarded SBIR Phase ll funding from the NIDCD. The SBIR program is the mechanism by which the NIH and other Federal agencies bring innovative solutions ...

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    21. Optovue Announces Retirement of Prominent Industry Veteran John Hawley

      Optovue Announces Retirement of Prominent Industry Veteran John Hawley

      - Optovue the global leader in the development of optical coherence tomography ( OCT ) and OCT angiography ( OCTA ), today announced the retirement of renowned industry veteran John Hawley, the company’s senior vice president of global sales. Hawley will retire on July 1, 2018 and remain with Optovue in an advisory role. Prominent industry veteran John Hawley retires from Optovue. Tweet this “For the past 10 years, I have worked side-by-side with John as we built Optovue from a fledgling start-up to the global company we are today,” said Jay Wei, founder and chief executive officer of Optovue. “As a result of ...

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      Mentions: Optovue Jay Wei
    22. Heidelberg Engineering’s SPECTRALIS OCT2 Module Headed to the International Space Station

      Heidelberg Engineering’s SPECTRALIS OCT2 Module Headed to the International Space Station

      NASA has been conducting research on the effects of microgravity on vision using the SPECTRALIS imaging platform since 2013. Heidelberg Engineering, a privately-held imaging solutions company focused on advanced diagnostic instruments for eye care professionals, announced the continuation of the SPECTRALIS space odyssey as the SPECTRALIS imaging platform with the company’s next-generation OCT2 Module is headed for the International Space Station (ISS). NASA launched the SPECTRALIS with OCT2 Module to the ISS aboard the Antares 230 Cygnus CRS OA-9, also known as Orbital Sciences CRS Flight 9E on May 21, 2018 from Wallops Island, Virginia. The device will be ...

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    23. Avinger Receives FDA Clearance of Next Generation Pantheris Device

      Avinger Receives FDA Clearance of Next Generation Pantheris Device

      The Pantheris Lumivascular Atherectomy System is the first-ever image-guided atherectomy device for treatment of peripheral artery disease Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease. Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. Peripheral artery disease is projected to affect more than 21 million people ...

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      Mentions: FDA Avinger
    24. New software generates high-speed, low latency OCT images by linking waveform digitizers to GPUs using True DMA

      New software generates high-speed, low latency OCT images by linking waveform digitizers to GPUs using True DMA

      AlazarTech, a manufacturer of high-performance, low-cost PC-Based Instruments, today announced the release of a new OCT Signal Processing Library called ATS‑GMA-OCT™ for use with AMD Radeon™ Pro Graphical Processing Units (GPUs). ATS-GMA-OCT provides out-of-the-box OCT imaging. It consists of a library of OpenCL kernels that operate on the data acquired by AlazarTech waveform digitizers. Up to 1.9 million FFTs per second can be calculated, which is more than sufficient for existing swept sources on the market. Windowing, Zero Padding, Dispersion Compensation, and Log functions are also included. The unique modular API for ATS-GMA-OCT allows users to customize their ...

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