1. Articles in category: Other Business News

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    1. Michelson Diagnostics wins Regulatory Approval for VivoSight OCT Scanner in Australia

      Michelson Diagnostics wins Regulatory Approval for VivoSight OCT Scanner in Australia

      Michelson Diagnostics Press release: Michelson Diagnostics the UK based medical device company has been given regulatory approval by the Therapeutics Goods Administration (TGA) in Australia to start selling its market leading VivoSight OCT Scanner. Australia has the highest incidence of skin cancer in the world and the number of people needing treatment continues to grow. The Australian Institute of Health and Welfare and Cancer Australia estimates there were 430,000 new cases of Non-Melanoma Skin Cancer diagnosed in 2008. This is approximately four-fold higher than the number of new cases diagnosed in the UK. In a recent position statement, the ...

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    2. Optical Coherence Tomography (OCT) - Comparative Biosciences Inc.

      Optical Coherence Tomography (OCT) - Comparative Biosciences Inc.

      CBI is proud to announce that it is now offering optical coherence tomography (OCT) for research and toxicology studies in laboratory animals. Optical coherence tomography (OCT) is an optical signal acquisition and processing method that captures micrometer-resolution, three-dimensional images from within biologic tissues and in particular, eyes. Our Envisu R2200 SDOIS Imaging System (Bioptigen, Inc) allows us to assess the retina, optic nerve, retinal vasculature, lens and anterior segment. Doppler assessment of ocular venous and arterial blood flow is also available. OCT allows us to capture a wide range of in life changes in the retina, and optic nerve and ...

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    3. AngioLight Completes Animal Study at Fu Wai Hospital; Begins Preparing for China Food and Drug Administration (CFDA ...

      AngioLight Completes Animal Study at Fu Wai Hospital; Begins Preparing for China Food and Drug Administration (CFDA ...

      AngioLight , an early stage, pre-clinical interventional cardiovascular medical device company, has successfully completed an initial animal study of the AngioLight System at Fu Wai Hospital, a leading cardiovascular center located in Beijing. The study paves the way for AngioLight to go forward in China with full-scale animal and clinical testing of the system, which will begin following the anticipated completion of study protocols, hospital review and required China Food and Drug Administration (CFDA) approvals. The AngioLight System is a novel light-based diagnostic catheter designed to provide interventional cardiologists and radiologists with vessel diameter and area measurements that will help improve ...

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    4. OptiMedica Wins Prestigious 2013 Red Herring 100 North America Award

      OptiMedica Wins Prestigious 2013 Red Herring 100 North America Award

      OptiMedica Corp . has announced that it received a Red Herring 100 North America award, which honors the continent’s most promising private venture technology companies. OptiMedica was selected by Red Herring's editorial staff based on both quantitative and qualitative criteria, such as intellectual property, disruptiveness of the solution in the market, technological advantage, management quality, strategy and market penetration. Alex Vieux, chairman and CEO of Red Herring, presented the awards during a ceremony on May 23, 2013. “Optimization of corneal incision parameters with a femtosecond laser for cataract surgery.” Red Herring 100 Awards are widely recognized as one of ...

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    5. Global Markets and Technologies for Optical Coherence Tomography (OCT) – Focus on Full Field and Optical Delay

      Global Markets and Technologies for Optical Coherence Tomography (OCT) – Focus on Full Field and Optical Delay

      BCC’s aim in conducting this study is to offer synopsis of the current and future characteristics of the global market for optical coherence tomography (OCT). The key objective is to present a comprehensive analysis and future trend and research of OCT as an important tool for the usage of this technique in imaging. This report explores present and future different OCT techniques and their usage and developments within the OCT market. This report includes different types of OCT techniques such as time domain and large-field high-speed polarization sensitive system, Fourier domain or spectral domain and time-encoded frequency domain or ...

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    6. Study shows VivoSight OCT could help Eyelid Cancer Surgery

      Study shows VivoSight OCT could help Eyelid Cancer Surgery

      Michelson Diagnostics Press Release - In what is believed to be the first ever study to investigate OCT (Optical Coherence Tomography) imaging of skin cancers in the eyelids and skin surrounding the eye, the Dept of Opthalmology, Maidstone and Tunbridge Wells NHS Trust have shown that OCT scanning can accurately reveal the margins of tumours. The study, which was conducted using the market leading VivoSight OCT scanner manufactured by Michelson Diagnostics, showed a positive correlation between tumour margins located using OCT and histology, the 'gold standard'. This breakthrough could ultimately lead to routine use of OCT scanning to plan delicate eyelid ...

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    7. First Human Clinical Images Available with OCTIS™ Thanks to Tomophase Corporation and the Thoraxklinik, University of Heidelberg

      First Human Clinical Images Available with OCTIS™ Thanks to Tomophase Corporation and the Thoraxklinik, University of Heidelberg

      Tomophase Corporation, a leading developer of minimally invasive optical coherence tomography (OCT) tissue imaging devices, announced today that the Thoraxklinik at the University of Heidelberg, Germany has taken the first OCTIS images in clinical patients with the Tomophase OCT Imaging System (OCTIS™). On Tuesday, May 7th Tomophase OCTIS was used for the first time to examine the airways of a patient undergoing bronchoscopy at the Thoraxklinik. The following day another patient was examined. (Courtesy of the Thoraxklinik, University of Heidelberg) The clinicians were quite intrigued of the results and plan to do further work in due course. The Tomophase OCTIS ...

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    8. Global OCT imaging market: $645 million industry by 2012

      Global OCT imaging market: $645 million industry by 2012

      The global OCT imaging market (optical coherence tomography) is suggested to have reached a value of around $525.7 million in 2010, and is believed to have then grown to a total of $645.4 million by the end of 2012. Optical coherence tomography (OCT) is a relatively new technology for performing high-resolution, cross-sectional imaging of tissue structure on the micron scale in situ and in real time. OCT has emerged as a powerful optical imaging instrument and technology. OCT performs high-resolution, cross-sectional tomographic imaging of the internal structure in 3-D materials, including biological tissues. The features of OCT that ...

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      Mentions: FDA
    9. NinePoint Medical launches esophageal imaging system

      NinePoint Medical launches esophageal imaging system

      Cambridge medical device company NinePoint Medical Inc. on Thursday launched its lead product in the U.S., an imaging system that makes it easier to examine and detect diseases of the esophagus. NinePoint’s proprietary NvisionVLE Imaging System was granted 510(k) clearance in December 2011 to be used as an imaging tool in the evaluation of human tissue microstructure. Last month, it received additional clearance to to include imaging of esophageal tissue microstructure. In June 2012, the device received European CE mark approval .

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    10. NinePoint Medical Announces U.S. Commercial Availability of the NvisionVLE™ Imaging System

      NinePoint Medical Announces U.S. Commercial Availability of the NvisionVLE™ Imaging System

      NinePoint Press Release - NinePoint Medical, Inc., an emerging leader in the development of medical devices for advanced optical imaging, today announced the commercial launch of its proprietary NvisionVLE ™ Imaging System in the United States. In addition, NinePoint today announced the launch of its newly redesigned website, www.ninepointmedical.com . In December 2011, the NvisionVLE Imaging System received 510(k) clearance from the U.S. Food and Drug Administration for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. Last month, NinePoint received 510(k) clearance to expand the System ...

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    11. OCT imaging market led by Carl Zeiss and St. Jude Medical

      OCT imaging market led by Carl Zeiss and St. Jude Medical

      The optical coherence tomography imaging market (OCT) is estimated to have reached a valuation of $645.4 million by the end of 2012, increasing from approximately $525.7 million in 2010. Optical coherence tomography is an optical signal acquisition and processing method. It captures micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). Optical coherence tomography is an interferometric technique, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is widely accepted for clinical diagnostics in ophthalmology, dentistry, cardiology, dermatology and also has broadened its application ...

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    12. Lightlab Imaging v. Axsun Technologies and Volcano - The National Law Review

      Lightlab Imaging v. Axsun Technologies and Volcano - The National Law Review

      A scientific or technological advantage is something to be protected. A case in the Business Litigation Session of Suffolk Superior Court demonstrates how cutthroat competition can be in the medical device industry and how the law deals with companies that disregard fair trade practices to gain an unfair advantage. In 2007, Lightlab Imaging, a company that provides OCT medical imaging for human coronary arteries, had developed the most powerful laser in the industry. Lightlab had a cooperative relationship with Axsun to convert Axsun’s basic laser into one that could be used by Lightlab. Volcano, a competitor of Lightlab, desired ...

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    13. Carl Zeiss Meditec improves its results in first six months of financial year 2012/2013

      Carl Zeiss Meditec improves its results in first six months of financial year 2012/2013

      The Ophthalmic Systems SBU was affected by a high level of competition. The effects of the model change in the area of optical coherence tomography (OCT) also impacted this SBU. A 4.9% decline in revenue to € 175.8 million was countered in the first six months of the year by a positive trend in incoming orders, which slightly surpasses the previous year's level.

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    14. NinePoint Medical to Present NvisionVLE Clinical Data at Digestive Disease Week 2013

      NinePoint Medical to Present NvisionVLE Clinical Data at Digestive Disease Week 2013

      NinePoint Medical Press Release - NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo imaging, today announced that new clinical data on its proprietary NvisionVLE ™ Imaging System will be featured in five poster presentations during Digestive Disease Week (DDW) taking place May 18-21, 2013, in Orlando, Fla. In addition, researchers from Massachusetts General Hospital (MGH) will highlight the core imaging technology of NvisionVLE, as well as a follow-on confocal endomicroscopy system, in two oral and two poster presentations. NinePoint licensed the imaging technology from MGH in 2010 as part of the largest intellectual property agreement ...

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    15. Mirrorcle Technologies announces availability of 4.2mm diameter MEMS 2-Axis mirrors

      Mirrorcle Technologies announces availability of 4.2mm diameter MEMS 2-Axis mirrors

      Mirrorcle Technologies Press Release - Mirrorcle Technologies announces availability of 4.2mm diameter MEMS mirrors Mirrorcle Technologies, Inc (MTI), the California-based manufacturer of patented, gimbal-less MEMS micromirror devices, today announces the availability of a larger category of mirrors. Until now, the company has been offering integrated mirror devices ranging from 0.8mm to 1.7mm in diameter, and bonded mirrors from 0.8mm to 3.6mm in diameter. Mirrorcle’s bonded MEMS mirror devices are modular in design, consisting of an actuator ‘engine’ and a mirror of customer-selected size. With a variety of different MEMS actuators, a selection of aluminum or ...

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    16. Advocating For Improved Treatment And Outcomes For Wet Age-Related Macular Degeneration In Australia - Cite Affordability a Barrier to Usage of SD-OCT

      Advocating For Improved Treatment And Outcomes For Wet Age-Related Macular Degeneration In Australia - Cite Affordability a Barrier to Usage of SD-OCT

      The Angiogenesis Foundation released a new white paper, "Advocating for Improved Treatment and Outcomes for Wet Age-Related Macular Degeneration" (AMD). Wet AMD is the most common form of blindness in people 50 years or older in developed nations. The report is based on the Australian Wet Age-Related Macular Degeneration Coalition Expert Summit convened in Sydney, Australia last July by the Angiogenesis Foundation and Macular Degeneration Foundation, where multiple healthcare stakeholders gathered to address barriers to timely and optimal care for Australian patients who suffer from vision loss due to wet AMD. The document summarizes key discussions from the summit and ...

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    17. Bioptigen introduces 1 µm resolution SD-OCT imaging system in collaboration with NKT Photonics supercontinuum white light laser source at ARVO conference in Seattle

      Bioptigen introduces 1 µm resolution SD-OCT imaging system in collaboration with NKT Photonics supercontinuum white light laser source at ARVO conference in Seattle

      Bioptigen/NKT Press Release - Bioptigen Inc. has introduced 1 um axial resolution imaging to its line of Envisu TM spectral domain OCT systems. The company has now integrated NKT Photonics SuperK supercontinuum laser with Bioptigen’s new 300 nm spectrometer to achieve a breakthrough in ophthalmic imaging for preclinical research. “The progression to 1 um extreme resolution imaging is an exciting advancement for our Envisu R-Class research product line”, said Dr. Eric Buckland, CEO of Bioptigen. “The importance of this innovation is that it offers researchers true cellular-level in vivo optical histology. This Extreme High Resolution (XHR) capability is unlocked ...

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    18. Volcano Corporation ( VOLC ) Reached 3-year Low of $20.47

      Volcano Corporation ( VOLC ) Reached 3-year Low of $20.47

      The price of Volcano Corporation ( VOLC ) shares has declined to close to the 3-year low of $20.47, which is 40.9% off the 3-year high of $33.90. Volcano Corporation designs , develops, manufactures and commercializes a suite of intravascular ultrasound (IVUS) and functional measurement ( FM ) products that enhance the diagnosis and treatment of vascular and structural heart disease. Volcano Corporation has a market cap of $1.11 billion; its shares were traded at around $20.47 with a P/E ratio of 136.986 and a P/S ratio of 2.86. For its fourth quarter 2012 ended December ...

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    19. NinePoint Medical Receives Additional FDA 510(k) Clearance for NvisionVLE Imaging System

      NinePoint Medical Receives Additional FDA 510(k) Clearance for NvisionVLE Imaging System

      NinePoint Medical Press Release - NinePoint Medical, Inc. , an emerging leader in the development of medical devices for in vivo imaging, today announced that it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NvisionVLE ™ Imaging System, expanding the system’s indication to include imaging of esophageal tissue microstructure. In January 2012, the company announced 510(k) clearance from the FDA to market its NvisionVLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. “The NvisionVLE Imaging System ...

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    20. Volcano Corporation Schedules First Quarter Conference Call, Webcast

      Volcano Corporation Schedules First Quarter Conference Call, Webcast

      Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced it will report its operating results for the first quarter of fiscal 2013 on Thursday, May 2 . The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Daylight Time ( 5 p.m., Eastern Daylight Time ), Thursday, May 2 , hosted by Scott Huennekens , president and chief executive officer, and John Dahldorf , chief financial officer. The teleconference can ...

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    21. Terumo Commences Sales of OFDI Intravascular Imaging System in Japan "LUNAWAVE" OFDI System and "FastView" OFDI Imaging Catheter

      Terumo Commences Sales of OFDI Intravascular Imaging System in Japan "LUNAWAVE" OFDI System and "FastView" OFDI Imaging Catheter

      Terumo Corporation Press Release - Terumo Corporation announced that from this April it has begun a Japanese sales launch of its "LUNAWAVE™" OFDI system, a light based intravascular imaging system, as well as its "FastView™" OFDI imaging catheter. Terumo aims to achieve the revenue of 1.7 billion yen ($17.3M) for both products in fiscal year 2013. OFDI (Optical Frequency Domain Imaging) employs light applied to the vessel wall from the tip of a catheter, and constructs an intravascular cross-sectional image through a new technology that analyzes the back scattered light from the vessel walls. It is mainly utilized in ...

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    22. Optovue announces Bill Jackson joining team as VP of Regulatory & Quality

      Optovue announces Bill Jackson joining team as VP of Regulatory & Quality

      Optovue, Inc. announces that Bill Jackson has joined the company as VP of Regulatory and Quality Assurance. Bill is a senior level regulatory, clinical and quality assurance executive with over 30 years of regulatory experience and 25 years in Quality for class II and III medical device manufacturers. Bill has lead submissions to over 75 countries and was on the committee that wrote the medical directives in Europe. In addition to running a successful consulting practice for over a decade, Bill has previously held VP level positions at MiMedx Group, and TranS1. Bill started his career in the hospital/research ...

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    23. LLTech Updates Its Atlas of Images Acquired with LightCT Scanner

      LLTech Updates Its Atlas of Images Acquired with LightCT Scanner

      LLTech Press Release - LLTech Updated Its Atlas of Images Acquired with its LightCT Scanner. To see PDF click HERE . To summarize the results we have obtained in pre-clinical studies to date: Breast: 75 samples, 92% sensitivity 77% specificity Lymph nodes: 45 samples, 100% sensitivity 97% specificity Skin: Epidermis and adnexae, collagen bundles of dermis and hypodermis identified through architectural and cellular details. Pathological structures distinguished from normal structures. Brain: Neurons, myelin fibers, CNS vasculature clearly identified. Cortex discriminated from white matter. Tumors such as meningiomas, low and high-grade gliomas and choroid plexus papilloma imaged. Cornea: Precise visualization of structures in ...

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