1. Articles in category: Other Business News

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    1. Axsun Technologies Announces Definitive Agreement to be acquired by Excelitas Technologies

      Axsun Technologies Announces Definitive Agreement to be acquired by Excelitas Technologies

      Axsun Technologies Inc., an Anzu Partners portfolio company, today announced that it has signed a definitive agreement to be acquired by Excelitas Technologies ® Corp., a global technology leader focused on delivering innovative, customized photonic solutions. The terms of the agreement are not being disclosed and the transaction is expected to close in early 2019. Jonathan Hartmann , CEO of Axsun, commented, "This is an outstanding opportunity for Axsun, our customers, and our employees as we continue to expand our product line and develop new markets together with Excelitas." "Our partnership with Anzu Partners has been outstanding, and we are grateful for ...

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    2. Avinger Announces Successful Treatment of 500th Patient with Next-Generation Pantheris Device

      Avinger Announces Successful Treatment of 500th 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 59 sites globally have successfully treated more than 500 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 and features a number of improvements intended to augment the performance and reliability of the product. Importantly, clinical results have remained consistently positive ...

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      Mentions: FDA Avinger
    3. Excelitas Technologies Announces Agreement to Acquire Axsun Technologies

      Excelitas Technologies Announces Agreement to Acquire Axsun Technologies

      Excelitas expands portfolio of high performance photonics solutions serving the Medical and Industrial markets. W Excelitas Technologies ® Corp., a global technology leader focused on delivering innovative, customized photonic solutions, today announced that it has signed a definitive agreement to acquire Axsun Technologies (Billerica, MA USA). Axsun is a privately-held company specializing in the development and production of innovative, MEMS-based light engines for high performance medical imaging and industrial spectroscopy applications. Terms of the agreement are not being disclosed and the transaction is expected to Close in early 2019. F or more information on Excelitas, visit www.excelitas.com. About Excelitas ...

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    4. Moody's says Excelitas' proposed $80 million first lien term loan facility to acquire Axsun is a moderate credit negative; ratings unaffected

      Moody's says Excelitas' proposed $80 million first lien term loan facility to acquire Axsun is a moderate credit negative; ratings unaffected

      Moody's Investors Service ("Moody's") says EXC Holdings III Corp.'s (dba Excelitas) proposed $80 million incremental first lien term loan facility to fund the acquisition of Axsun is a modest credit negative, but it does not impact the company's B3 Corporate Family Ratings or stable rating outlook. Following the add-on, the USD denominated first lien term loan will increase to $685 million from $605 million ($681 million outstanding proforma at September 30, 2018). The $80 million proceeds along with $1.2 million of cash on hand will be used to fund the acquisition and approximately $5 million ...

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    5. Thorlabs Extends OCT Offering to Include Spectral-Domain Polarization-Sensitive Device

      Thorlabs Extends OCT Offering to Include Spectral-Domain Polarization-Sensitive Device

      Thorlabs announced today that it has expanded its well-established Telesto™ OCT line to include two complete imaging systems that offer polarization-sensitive detection. With this new release, the TEL210PSC2 and TEL220PSC2 become the first commercially available Polarization-Sensitive Spectral-Domain OCT systems on the market, providing a new standard for highly reproducible and robust 2D and 3D imaging and analysis of polarizing samples. As with Thorlabs’ previously released Telesto OCT technologies, these new systems are available in both long-range (TEL210PS) and general-purpose (TEL220PS – 5.5 µm axial resolution) variants. Each offers the same low roll-off and high sensitivity performance found in other members ...

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    6. Avinger Announces Commercial Launch in Australia

      Avinger Announces Commercial Launch in Australia

      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 commercial launch of its Pantheris image-guided atherectomy system in Australia. Avinger recently completed an exclusive distribution agreement with Diverse Devices Pty Ltd. for the sales and marketing of Avinger’s proprietary Lumivascular products in Australia. In addition, the Company announced it has received notice from Australia’s Therapeutic Goods Administration (TGA) that the Pantheris image-guided atherectomy system has been included on the Australian Register of Therapeutic Goods, which permits ...

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      Mentions: Avinger
    7. Notal Vision Announces FDA Grants Breakthrough Device Designation for Pioneering Patient-Operated Home Optical Coherence Tomography (OCT) System

      Notal Vision Announces FDA Grants Breakthrough Device Designation for Pioneering Patient-Operated Home Optical Coherence Tomography (OCT) System

      Notal Vision, Ltd., ("Notal") a privately-held ophthalmic diagnostic services company, focused on advancing eye care by extending ophthalmic disease management from the clinic to the home, has announced the U.S. Food and Drug Administration (FDA) granted the Notal Vision Home-based Optical Coherence Tomography (OCT) System with "Breakthrough Device" designation for the agreed upon indications for use. This designation indicates that FDA intends to provide interactive and timely communication with the sponsor during device development and throughout the review process for various types of premarket submissions. FDA's Breakthrough Devices Program was established in late 2016 to help patients gain ...

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    8. Michelson Diagnostics: Imaging Reveals Changes in Blood Vessel Growth in Deadly Melanoma Skin Cance

      Michelson Diagnostics: Imaging Reveals Changes in Blood Vessel Growth in Deadly Melanoma Skin Cance

      A new clinical study has shown that Dynamic Optical Coherence Tomography imaging of melanomas (D-OCT) reveals changes to the blood vessels that correlate with the depth of invasion of the melanoma. Researchers believe this could lead to a new faster method of rapidly assessing how dangerous a given melanoma is. A more rapid assessment of the risk would potentially allow patients with more serious invasive disease access to the right treatment more directly, doing away with delays inherent in the traditional diagnosis. The technique may also lead to reducing the number of patients with less aggressive tumours receiving sentinel lymph ...

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    9. Mirrorcle laser-cuts ribbon on cleanroom facility for volume MEMS mirror

      Mirrorcle laser-cuts ribbon on cleanroom facility for volume MEMS mirror

      In a ribbon cutting ceremony Mirrorcle Technologies inaugurated its new cleanroom space at the company’s Richmond, CA headquarters. Reflecting the company’s core competency of reliable optical beam-steering, the ribbon was cut by one of company’s latest products – a laser beam Scan Module which features a powerful 1W, blue (450nm) laser that was developed for the emerging dynamic solid-state lighting (phosphor lighting) market. As the company’s founder and CEO, Dr. Veljko Milanovic, dragged his finger on a tablet controlling the battery-powered Scan Module via Bluetooth, the laser beam, which was steered by the company’s 1.2mm ...

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    10. 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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    11. 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
    12. 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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    13. 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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    14. 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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    15. 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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    16. 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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    17. 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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    18. 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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    19. 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
    20. 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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    21. 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
    22. 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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    23. 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
    24. 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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