1. Articles in category: Other Business News

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    1. Canon Xephilio OCT-A1 Optical Coherence Tomography Device Receives FDA 510(k) Clearance

      Canon Xephilio OCT-A1 Optical Coherence Tomography Device Receives FDA 510(k) Clearance

      Expanding the company's lineup of eye-care product offerings, Canon U.S.A. , Inc., a leader in digital imaging solutions, is pleased to announce the new intuitive, user-friendly Xephilio OCT-A1 Optical Coherence Tomography device from Canon Inc. This device features automated acquisition functionality, which makes it easy to use, allowing healthcare professionals to obtain high-quality reproducible scans and images. The Xephilio OCT-A1 Optical Coherence Tomography device has received FDA 510(k) clearance for sale in the United States of America 1. The Xephilio OCT-A1 Optical Coherence Tomography device, together with the required RX Capture software, computer and LCD monitor (collectively ...

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    2. Specsavers Installs the 350th Topcon Maestro Fully Automated OCT

      Specsavers Installs the 350th Topcon Maestro Fully Automated OCT

      Leading OCT Technology Enables Specsavers Optometrists to Provide Unsurpassed Eye Care to Their Patients Topcon Medical Systems (TMS), of Oakland, NJ, USA, a leading provider of diagnostic equipment and software solutions for the eye care industry, and Specsavers, Australia’s #1 optometry practice network, are pleased to announce the installation of the 350th Topcon Maestro Fully Automated OCT/Fundus Camera into Specsavers retail locations across Australia and New Zealand. After careful consideration of several devices, Specsavers chose to incorporate the Maestro OCT into all its locations based on its ease of use, space-saving design, enhanced diagnostic tools and clinical accuracy ...

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    3. ZEISS to showcase advancements in digital and surgical technology at ESCRS 2019

      ZEISS to showcase advancements in digital and surgical technology at ESCRS 2019

      During the 2019 European Society of Cataract and Refractive Surgery (ESCRS) Annual Meeting in Paris , ZEISS Medical Technology Segment will present new technologies advancing the digitalization of eye care and high-resolution imaging, helping doctors maximize clinical efficiency and performance. ZEISS ARTEVO 800 ZEISS CIRRUS 6000 including application ZEISS SL 800

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    4. Avinger Announces Commercial Launch and First Patients Treated in Hong Kong

      Avinger Announces Commercial Launch and First Patients Treated in Hong Kong

      Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the commercial launch of its Lumivascular products in Hong Kong. Avinger has an exclusive distribution agreement with Integmed Ltd. for the sale and marketing of Avinger’s Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion (CTO) crossing systems in Hong Kong. The first shipment of devices has been made under the agreement and training of Integmed’s sales and clinical support teams has been completed. Dr. Yiu Che Chan, a highly-experienced vascular ...

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    5. ZEISS Showcases New CIRRUS 6000 OCT System at the European Society of Retina Specialists 2019 Congress

      ZEISS Showcases New CIRRUS 6000 OCT System at the European Society of Retina Specialists 2019 Congress

      CIRRUS 6000 at EURETINA ZEISS Showcases New CIRRUS 6000 OCT System at the European Society of Retina Specialists 2019 Congress The ZEISS CIRRUS 6000, 100kHz OCT system promises to dramatically elevate the efficiency of eye care practices. ZEISS Medical Technology Segment expands its *CIRRUS ® — the most trusted Optical Coherence Tomography (OCT) with the launch of its new CIRRUS 6000, 100kHz ultra-fast OCT system that promises to dramatically elevate the efficiency of advanced care practices. CIRRUS 6000 is the latest addition to an already robust portfolio of OCT devices that are designed to meet the needs of all types and levels ...

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    6. Cylite Announces Series B Funding Round led by Main Sequence Ventures

      Cylite Announces Series B Funding Round led by Main Sequence Ventures

      Cylite Pty Ltd, a developer of 3D imaging and measurement systems for Ophthalmology and Optometry announces the successful close of its Series B funding round led by leading Australian VC firm Main Sequence Ventures with participation from existing US and Australian investors. The new funding leverages previous funding, and grants from the Australian government, to build additional manufacturing capacity for Cylite’s Hyperparallel OCT (HP-OCT) platform as well as extend its sales and support networks in Europe and the US. The investment will also support further R&D to provide new diagnostic capabilities for improved outcomes in anterior segment cataract ...

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      Mentions: Cylite
    7. Topcon Launches the Maestro2 with Automated OCTA

      Topcon Launches the Maestro2 with Automated OCTA

      Topcon is pleased to announce the launch of the Maestro2 Automated OCT/Fundus Camera, now with OCTA. Building on the incredible success of its predecessor, the 3D OCT-1 Maestro, the new Maestro2 adds even more clinical utility to its multimodality platform. 1 The Maestro2 is a fully automated OCT system that can capture high resolution non-mydriatic, true color fundus photography, OCT, and OCTA with the single press of a button. This multimodal system also now offers the Hood Report for the structure/function analysis of glaucoma. Additionally, it features a 360° rotating intuitive touchscreen, a small footprint and space-saving design ...

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    8. Perimeter Medical Imaging Closes Oversubscribed $C4.4M Financing

      Perimeter Medical Imaging Closes Oversubscribed $C4.4M Financing

      Perimeter Medical Imaging, Inc., the leader in real-time tissue imaging in the operating suite is pleased to announce the completion of a pre-public financing round raising $C4.4million. Perimeter intends to go public via a reverse takeover (RTO) with New World Resources (NW) in Q4 of this year. Funds raised in this pre-public round and anticipated RTO will support the commercialization of Perimeter's U.S. Food and Drug Administration (FDA) cleared OTISTM medical imaging technology. OTISTM is deployed in the surgical suite, empowering surgeons with real-time tissue imaging to help optimize cancer surgery outcomes. "We are pleased to have ...

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    9. Avinger Announces Presentations by Key Opinion Leaders at AMP 2019 Clinical Conference

      Avinger Announces Presentations by Key Opinion Leaders at AMP 2019 Clinical Conference

      Avinger, Inc. (NASDAQ: AVGR ), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced four podium presentations featuring the Company’s Lumivascular technology at the annual AMP (Amputation Prevention Symposium) conference occurring last week. Key opinion leaders in the fields of interventional cardiology highlighted Avinger ’s Lumivascular technology, which includes the Pantheris family of image-guided atherectomy products and the Ocelot family of image-guided chronic total occlusion (CTO) crossing products, in the following sessions: Dr. Thomas Davis, an interventional cardiologist at Eastlake Cardiovascular and one ...

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      Mentions: Avinger
    10. Dr. Kester Nahen joins Notal Vision as Chief Commercial Officer

      Dr. Kester Nahen joins Notal Vision as Chief Commercial Officer

      Notal Vision, Inc., a company focused on advancing eye care with precision medicine by extending disease management from the clinic to the home, is pleased to announce the appointment of Kester Nahen, PhD to Chief Commercial Officer. Dr. Nahen is a medical device industry expert and brings more than 18 years of well-rounded international business experience in product management, medical science, clinical research, marketing, sales, professional education, and business development to the company. "I am delighted to welcome Kester to the Notal Vision executive team,” stated Dr. Susan Orr, Chief Executive Officer of Notal Vision. “I am confident that his ...

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    11. NinePoint Medical Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System

      NinePoint Medical Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System

      NinePoint Medical, Inc ., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use in the pancreas and bile duct. These anatomical indications add to the previously existing esophageal applications for NinePoint’s state-of-the-art Optical Coherence Tomography (OCT) imaging platform. The NvisionVLE Imaging System provides physicians real-time, high-resolution volumetric images of the tissue surface and subsurface. This allows gastroenterologists to thoroughly evaluate tissue for regions of interest that may not be visible ...

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    12. Altris AI algorithm for retinal conditions detection on Optical Coherence Tomography (OCT) scans gets European CE-mark certification

      Altris AI algorithm for retinal conditions detection on Optical Coherence Tomography (OCT) scans gets European CE-mark certification

      Altris AI (Altris, Inc), a global artificial intelligence (AI) healthcare company, announced that it has received the CE Mark approval for its Standard Functionality for retinal conditions detection on Optical Coherence Tomography (OCT) scans. Altris AI Standard Functionality is ready for preliminary screening of retinal diseases in clinical practice. Altris AI detects retinal pathological signs of more than 30 retinal diseases and classifies them according to severities. Altris AI Standard Functionality for OCT scans interpretation, the first of multiple Altris AI versions, is now approved for commercial sale within the European Union. Altris AI diagnostic software is based on computer ...

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      Mentions: Altris AI Huvitz
    13. Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States

      Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States

      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 that physicians in four U.S. sites have successfully treated several patients with the Pantheris SV (Small Vessel) image-guided atherectomy system. These initial cases are part of a limited launch at up to 13 leading clinical centers prior to expanding commercial distribution to additional treatment facilities in the U.S. Pantheris SV, a product line extension of Avinger’s onboard image-guided atherectomy platform, expands Avinger’s portfolio of atherectomy devices for ...

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      Mentions: Avinger
    14. China's diagnostic technology gets U.S. FDA approval

      China's diagnostic technology gets U.S. FDA approval

      A new diagnostic technology developed by Chinese scientists for improving coronary heart disease treatment has received market approval from the U.S. Food and Drug Administration (FDA), according to China's Ministry of Science and Technology Monday. The technology, called Quantitative Flow Ratio (QFR) measurement system, was jointly developed by Pulse Medical Imaging Technology (Shanghai) Co and a group of researchers with Shanghai Jiaotong University. Based on the computational analysis of X-ray coronary angiography, the system is able to obtain QFR noninvasively, which can evaluate coronary artery blockage and function and then help doctors decide whether a patient needs to ...

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    15. Notal Vision Diagnostic Clinic reports completion of 6 million ForeseeHome AMD home-monitoring tests

      Notal Vision Diagnostic Clinic reports completion of 6 million ForeseeHome AMD home-monitoring tests

      Notal Vision, Inc., a company focused on advancing eye care with precision medicine by extending disease management from the clinic to the home, celebrates the completion of six million patient tests performed with ForeseeHome, the first FDA-cleared home-monitoring device for patients with intermediate dry Age-related Macular Degeneration (AMD) at risk for developing wet AMD. ForeseeHome uses a patented technology, Preferential Hyperacuity Perimetry® (PHP), that can identify minute changes in the central 14 degrees of visual field before the patient has any visual symptoms. During the test, which takes about three minutes, the central macula is evaluated for changes in metamorphopsia ...

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      Mentions: Notal Vision
    16. ZEISS Marks Milestone for its New North America High Tech Site in Dublin, California

      ZEISS Marks Milestone for its New North America High Tech Site in Dublin, California

      The internationally leading optics and optoelectronics technology enterprise ZEISS completed the “steel topping out” phase of its new high tech site in the San Francisco Bay Area. The new site in Dublin is an integral part of ZEISS’ global investment strategy and is one element in a string of international projects aimed at expanding, modernizing and realigning sites that ZEISS has been implementing in locations such as Germany, Europe and Asia since 2011. “Our investments are focused on leveraging the existing potential in our growth markets,” explains Dr. Christian Mueller, Member of the Executive Board and CFO of the ZEISS ...

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    17. Lumedica Receives NIH Grant for Low Cost Retinal Optical Coherence Tomography for Point of Care Use

      Lumedica Receives NIH Grant for Low Cost Retinal Optical Coherence Tomography for Point of Care Use

      Lumedica Receives a 2019 NIH Grant for $499,978 for Low Cost Retinal Optical Coherence Tomography for Point of Care Use. The principal investigator is William Brown. The program began in 2016 and ends in 2021. Below is a summary of the proposed work. The objective of this research is to create a clinical prototype of a new optical coherence tomography (OCT) system suitable for diagnostic retinal imaging at the point of care. The target system price will be one third the price of currently available research OCT systems while providing performance comparable to other entry level OCT imaging systems ...

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    18. ZEISS Ophthalmic Digital Summit 2019

      ZEISS Ophthalmic Digital Summit 2019

      In partnership with ODwire, Carl Zeiss Meditec, Inc. and Carl Zeiss Vision invite you to the ZEISS Ophthalmic Digital Summit 2019 . This two-day complimentary program offers live sessions and an interactive product showcase—all within a virtual exhibit hall—designed to provide you with the latest technology innovations and clinical solutions for your practice. Taught by industry leaders , you'll get trained and informed on how the Integrated Diagnostic Imaging platform and ZEISS leading imaging technologies will help shape the future of your practice. Event attendees will also be eligible for special show promotions and discounts on ZEISS instruments.

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    19. Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

      Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the 50 th patient enrolled in its INSIGHT clinical trial. The INSIGHT trial is a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris ® Lumivascular atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries. Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist, noted, “We are pleased to have the first 50 cases completed as part of our INSIGHT IDE study. Early ...

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      Mentions: Avinger
    20. Avinger Announces Commercial Launch of Ocelot in Australia

      Avinger Announces Commercial Launch of Ocelot in Australia

      First Patients Treated Successfully in Australia with Image-Guided CTO-Crossing Device REDWOOD, CA / ACCESSWIRE / July 8, 2019 / Avinger, Inc. (NASDAQ: AVGR ), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the commercial launch of its Ocelot image-guided chronic total occlusion (CTO) crossing system in Australia. As part of the Company’s exclusive distribution agreement with Diverse Devices Pty Ltd. for Avinger’s proprietary Lumivascular products in Australia, Ocelot completed the registration process with the Therapeutic Goods Administration (TGA) and is included on the Australian Register of Therapeutic ...

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      Mentions: Avinger
    21. Lumedica Receives $1M Phase II NIH-SBIR Grant, in Support of Detecting Eye Disease Around the World

      Lumedica Receives $1M Phase II NIH-SBIR Grant, in Support of Detecting Eye Disease Around the World

      Lumedica Inc., a privately held company, focused on improving access to eye care by creating low-cost, high performance, Optical Coherence Tomography (OCT) systems for research and clinical applications, received a $1M Phase II NIH-NEI SBIR grant in order to continue system and product development. OCT is considered the gold standard for early detection of Macular Degeneration, Diabetic Retinopathy and Glaucoma, all of which can occur without symptoms. When these diseases are detected early — such as with OCT — they can be managed without patients losing their vision. “We are grateful for the ongoing support from the NIH-NEI, said Principal Investigator and ...

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      Mentions: Lumedica
    22. PhotoniCare Looks Behind Ear Drums to Help Diagnose Ear Infections

      PhotoniCare Looks Behind Ear Drums to Help Diagnose Ear Infections

      Middle ear infections are one of the most common reasons for visits to the pediatrician. However, because the middle ear is hidden from view by the ear drum, physicians must diagnose based on symptoms and a limited physical exam — and when patients have ambiguous or borderline symptoms, accurate diagnosis can be challenging. PhotoniCare’s TOMi Scope uses near-infrared light waves to provide 3D views beyond the ear drum into the middle ear, allowing physicians to visualize and better diagnose middle ear infections. Co-founder and CEO Ryan Shelton, Ph.D. answered a few of our questions about his company’s beginnings ...

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    23. Mentice and Siemens Healthineers bring a virtual patient to the angio-suite

      Mentice and Siemens Healthineers bring a virtual patient to the angio-suite

      Siemens Healthineers, a leading medical technology company and Mentice AB, a world leader in simulation solutions for endovascular therapies, announced today the collaboration to fully integrate Mentice’s VIST® Virtual Patient into the Artis icono angiography system from Siemens Healthineers. The VIST® Virtual Patient thus becomes a fully integrated simulation solution for the angio-suite. The global partnership between the two companies will allow interventional radiologists, neuroradiologists, and cardiologists to perform vascular and cardiac interventions on a virtual patient inside the angio-suite. “With an ever-increasing complexity of new interventional procedures, our customers strive to acquire and retain procedural skills while optimizing ...

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      Mentions: Siemens
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