1. Articles in category: Other Business News

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    1. ZEISS Medical Technology Announces Changes in Ophthalmic Devices Executive Leadership

      ZEISS Medical Technology Announces Changes in Ophthalmic Devices Executive Leadership

      Effective 1 May 2020, Jim Mazzo will retire from his position as President Ophthalmic Devices and Head of the Ophthalmic Devices Strategic Business Unit for ZEISS. He will continue to support ZEISS as an advisor. With over forty years in the ophthalmic industry, Jim has successfully transformed ZEISS Global Ophthalmic Devices as the number two industry leader in Ophthalmology by creating a strong customer focused organization within his three plus years with ZEISS. "I am very proud of what we have accomplished for customers and employees and pleased to hand over responsibility to Euan and the team. With this team ...

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    2. Cylite receives ISO 13485 Certification

      Cylite receives ISO 13485 Certification

      Cylite Pty Ltd, a developer and manufacturer of 4 th Generation OCT systems for Ophthalmology and Optometry, is pleased to announce that it has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems (QMS) following review by BSI. ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry. ISO 13485 certification affirms to Cylite’s patients and partners that the company is providing the best quality management systems and regulatory compliance for its 4 th generation OCT platform. Yameena Ratnayake, Cylite’s Quality Manager commented,” We are very ...

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      Mentions: Cylite
    3. Avinger Announces Publication of SCAN Clinical Study in Peer-Reviewed Journal

      Avinger Announces Publication of SCAN Clinical Study in Peer-Reviewed Journal

      vinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that the results of its SCAN clinical study have been published in the peer-reviewed journal BMC Medical Imaging. SCAN is a prospective, non-inferiority, post-market study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries. Study results showed that OCT imaging with Avinger's Pantheris system demonstrated statistical superiority or equivalence to IVUS on all parameters evaluated. While OCT has been documented to ...

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      Mentions: FDA Avinger
    4. Kylee Hall joins Cylite as VP Sales and Marketing

      Kylee Hall joins Cylite as VP Sales and Marketing

      ylite Pty Ltd, a company developing the next generation of diagnostic OCT systems for Ophthalmology and Optometry, is pleased to announce the appointment of Kylee Hall as Vice President, Sales and Marketing. Ms Hall is a medical device industry expert and brings more than 13 years of senior leadership in sales, marketing and corporate management. She has a record of accomplishment in executing best practice business, sales and marketing strategies in Ophthalmic and Surgical devices. "I am delighted to welcome Kylee to the Cylite executive team,” stated Dr. Steve Frisken, Chief Executive Officer of Cylite. “I am confident that her ...

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      Mentions: Cylite
    5. Merit Medical Reports Earnings for Fourth Quarter and Year Ended December 31, 2019, Gives FY 2020 Guidance

      Merit Medical Reports Earnings for Fourth Quarter and Year Ended December 31, 2019, Gives FY 2020 Guidance

      Merit noted that during the fourth quarter of 2019, it recorded an impairment expense of approximately $20.5 million related to its arrangement with NinePoint Medical, Inc., in which Merit fully impaired its loan to NinePoint and its option to purchase the outstanding equity of NinePoint. In addition, Merit recorded a write-off of $1.6 million of accrued interest related to the loan to NinePoint.  

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    6. Conavi Medical and Japan Lifeline Announce MHLW Approval of Novasight Hybrid Intravascular Imaging System for Japanese Market

      Conavi Medical and Japan Lifeline Announce MHLW Approval of Novasight Hybrid Intravascular Imaging System for Japanese Market

      Conavi Medical Inc. and Japan Lifeline are pleased to announce that they have received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the Novasight Hybrid TM intravascular imaging system. The Novasight Hybrid system is the world’s first clinical system capable of providing both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) on a single imaging catheter. The system also has Health Canada approval and FDA 510(k) clearance in the USA. Japan Lifeline is the exclusive distributor for this technology in Japan. Dr. Brian Courtney, Conavi Medical’s Chief Executive Officer, comments that ...

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    7. AI-based retinal fluid analytics of serial Notal Vision home OCT images offers insights into retinal disease dynamics

      AI-based retinal fluid analytics of serial Notal Vision home OCT images offers insights into retinal disease dynamics

      Longitudinal data on retinal imaging of age-related macular degeneration (AMD) patients using the final form factor of Notal Vision’s home OCT (NOTAL-OCT V3.0) was presented at the Angiogenesis, Exudation, and Degeneration meeting in Miami. The pipeline technology is designed to use home-based, patient-initiated retinal OCT scans to support the management of patients with exudative AMD, complementing existing standard of care as well as emerging longer acting drugs and drug delivery systems. “This is the first time nano-liter scale quantities of intra- and subretinal fluid have been tracked over time based on home OCT images and deep learning retinal ...

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    8. Optos eyes continued global growth with new eyecare technology made in Scotland

      Optos eyes continued global growth with new eyecare technology made in Scotland

      This March, the company will launch an addition to its flagship technology called optical coherence tomography (OCT), which uses light waves to take cross-section pictures of a patient’s retina. “On our latest device, we’re the first to allow an OCT scan to take place anywhere on the retina,” Kennedy explained. “That’s been developed here in Scotland and it allows doctors to see different layers, a bit like a CT scan, across the retina, whereas traditional devices typically only look at the central area. OCT scans are really important for many eye diseases as they allow you to ...

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    9. PhotoniCare's TOMi Scope takes Top Prize at SPIE and Photonics Media Prism Awards

      PhotoniCare's TOMi Scope takes Top Prize at SPIE and Photonics Media Prism Awards

      PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced the company’s TOMi ™ Scope was awarded best healthcare product at the 12th Annual Prism Awards in San Francisco. The Prism Awards is an annual international competition that honors the best new optics and photonics products on the market. Since 2008, SPIE, along with media partner Photonics Media, has presented awards to companies and individuals that are creating products that make a difference, solve problems, and improve life through photonics. The Prism Awards reflect the exponential growth, exciting developments, and rich technical innovations ...

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    10. Acucela Meets with NASA and TRISH for Phase 1 Update for SS-OCT Project

      Acucela Meets with NASA and TRISH for Phase 1 Update for SS-OCT Project

      Acucela Inc. (“Acucela”), a clinical-stage ophthalmology company and wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today that the company was invited to meet with NASA and the Translational Research Institute for Space Health (TRISH) *1 to present on January 30, 2020 the status of its Swept Source-OCT *2 (“SS-OCT”) device being developed for NASA’s Deep Space missions. The purpose of the meeting was to review and discuss progress of this Phase 1 project with the engineers, basic and medical scientists and program managers from NASA and TRISH. Additionally, a demonstration of the Phase 1 device ...

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    11. New OCT Image Analysis Capabilities From Wasatch Photonics

      New OCT Image Analysis Capabilities From Wasatch Photonics

      Wasatch Photonics is pleased to announce the expansion of our WP OCT Software and software development kits with new features to facilitate the translation of images into actionable information. These OCT image analysis capabilities lower the barrier to use for OCT by non-experts, and offer the potential for automated analysis of images in real time. The new features include image enhancement, layer segmentation, and classification functions based on powerful machine learning algorithms, and may be accessed from our user-friendly OCT image acquisition software or via our software development kits (SDKs). To help you see the possibilities, we have trained our ...

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    12. New Device Performs 3D “Optical Biopsies” Of Skin

      New Device Performs 3D “Optical Biopsies” Of Skin

      DAMAE Medical and NKT Photonics have worked together under the Eurostar financing program to combine the cutting-edge Line-field Confocal Optical Coherence Tomography (LC-OCT) imaging technology, developed by DAMAE Medical, with the innovative supercontinuum laser technology provided by NKT Photonics. With a broadband SuperK white light laser as a key component, DAMAE Medical has developed an in vivo skin imaging device which performs “optical biopsies” based on the new LC-OCT technology. This unique technique couples the technological advantages of OCT and confocal microscopy: high resolution at high penetration depth. The broadband near-infrared light from the laser combined with high aperture microscope ...

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    13. Avinger Enrolls First Patient in IMAGE-BTK Clinical Study Evaluating Safety and Efficacy Endpoints for Pantheris SV

      Avinger Enrolls First Patient in IMAGE-BTK Clinical Study Evaluating Safety and Efficacy Endpoints for Pantheris SV

      Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the initiation of the IMAGE-BTK clinical study for its Pantheris SV image-guided atherectomy system. IMAGE-BTK is a post-market trial designed to evaluate safety and efficacy endpoints for Pantheris SV in the treatment of peripheral artery lesions below-the-knee (BTK). Dr. Thomas Davis, an interventional cardiologist at Eastlake Cardiovascular, P.C. in Saint Claire Shores, Michigan, enrolled the first patient in IMAGE-BTK and will serve as the principal investigator of the study. After ...

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      Mentions: Avinger
    14. Avinger Announces Successful First Procedures in Europe with Ocelaris Chronic Total Occlusion (CTO) Image-Guided Crossing Device

      Avinger Announces Successful First Procedures in Europe with Ocelaris Chronic Total Occlusion (CTO) Image-Guided Crossing Device

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the first clinical experiences with the Ocelaris next-generation CTO crossing system utilizing Avinger's proprietary image-guided technology platform. Dr. Arne Schwindt, a vascular surgeon at St. Franziskus Hospital Münster, and Dr. Michael Lichtenberg, an interventional angiologist at Klinikum Hochsauerland, Arnsberg, used Ocelaris in multiple procedures across a variety of different lesion types and anatomy both above and below the knee. Avinger plans to continue supporting first cases with Ocelaris at ...

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    15. CPT codes for home OCT established

      CPT codes for home OCT established

      The AMA’s CPT® Editorial Panel has accepted three new category III codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT pipeline technology Notal Vision, Inc., a privately held ophthalmic diagnostic services company focused on advancing eye care with precision medicine by extending disease management from the clinic to the home, announced today that the American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel has established three new Category III codes (0604T, 0605T, 0606T) to report patient-initiated remote retinal optical coherence tomography (OCT) scans, which is performed using Notal Vision’s home-based ...

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    16. PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear

      PhotoniCare Announces FDA Clearance for First-In-Class Technology for Imaging the Ear

      PhotoniCare, Inc., a company dedicated to revolutionizing healthcare by providing physicians with better diagnostic tools, today announced that the U.S. Food & Drug Administration (FDA) has granted 510(k) clearance for its TOMi ™ Scope for non-invasive imaging of the middle ear. Using optical coherence tomography (OCT) high resolution depth imaging, TOMi Scope helps to determine the presence or absence of fluid in the middle ear and to characterize the fluid type. According to clinical guidelines, the presence of fluid in the middle ear is a primary indicator for determining infection. Designed to eliminate subjectivity and speculation, TOMi Scope allows physicians ...

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    17. Acucela to Participate in Biotech Showcase™ 2020

      Acucela to Participate in Biotech Showcase™ 2020

      Retinal Health Remote Monitoring Device (eyeMO®). A home-based, patient self-monitoring miniature optical coherence tomography (OCT) device, eyeMO® is designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression from neovascular retinal diseases.

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      Mentions: Acucela
    18. Avinger Receives CE Marking for Ocelaris, a Next-Generation Image-Guided CTO Crossing System

      Avinger Receives CE Marking for Ocelaris, a Next-Generation Image-Guided CTO Crossing System

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based systems for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced it has gained Conformité Européenne (CE) Marking for Ocelaris, a next-generation chronic total occlusion (CTO) crossing system utilizing Avinger's proprietary image-guided technology platform. CE Marking allows clinical use of Ocelaris in the European Union (EU) and certain other countries that recognize CE Marking. Ocelaris is not available for clinical use in the United States at this time. Ocelaris is a product line extension of Avinger's Ocelot family ...

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      Mentions: FDA Avinger
    19. New World Resources and Perimeter Medical Imaging Provide Updates Regarding Their Amalgamation Transaction and Announce Amended and Restated Arrangement Agreement

      New World Resources and Perimeter Medical Imaging Provide Updates Regarding Their Amalgamation Transaction and Announce Amended and Restated Arrangement Agreement

      New World Resources Corp. (TSXV: NW) ("New World") and Perimeter Medical Imaging, Inc. ("Perimeter") are pleased to announce that they have now agreed to a completion goal of Q1 of 2020 for their amalgamation by way of plan of arrangement (the "Transaction"). The Transaction is an arm's length transaction and will result in a reverse take-over and change of control of New World by the shareholders of Perimeter. The resulting publicly traded company (the "Resulting Issuer") will be named Perimeter Medical Imaging AI, Inc. and its management team will be led by Will Rosellini and Perimeter's newly appointed ...

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    20. Carl Zeiss Meditec achieves significant increase in sales and earnings in fiscal year 2018/19

      Carl Zeiss Meditec achieves significant increase in sales and earnings in fiscal year 2018/19

      In fiscal year 2018/19, Carl Zeiss Meditec generated revenue of €1,459.3m, resulting in an increase of 13.9% (adjusted for currency effects: +11.7%) compared with the same period of the prior year (prior year: €1,280.9m). Earnings before interest and taxes (EBIT) rose significantly, to €264.7m (prior year: €197.1m). The EBIT margin was 18.1% (prior year: 15.4%). “This was a record year for Carl Zeiss Meditec AG, to which all business units and regions contributed,” says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG. Ophthalmology and Microsurgery continue ...

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    21. Canon Inc. Realigns Strategy to Prepare for Eye Care Systems Business Growth

      Canon Inc. Realigns Strategy to Prepare for Eye Care Systems Business Growth

      As part of Canon Inc.’s global medical business strategic realignment, the eye care business operations within Canon U.S.A. Inc. will transfer to Canon Medical Systems USA, Inc. effective January 1, 2020. Canon’s shift in business operations will allow Canon Medical Systems USA, Inc. to offer ophthalmologic solutions to IDN customers, while leveraging full line medical imaging business synergies to address population health challenges associated with chronic conditions. Chronic conditions can include age-related macular degeneration, diabetic retinopathy, glaucoma, inherited retinal diseases and other retinal conditions that can lead to loss of vision and blindness. Positioning the eye ...

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