1. Articles in category: Other Business News

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    1. Luxmux Prism Award Finalist for New Compact Broadband Light Source

      Luxmux Prism Award Finalist for New Compact Broadband Light Source

      LUXMUX Technology Corporation ( Calgary, AB ) announced that that it will introduce its latest product, the BeST-SLED ® broadband light source at the Photonics West exhibition, Booth #4137, to be held from January 28-February 2 at the Moscone Center in San Francisco. The BeST-SLED ® has been selected as a finalist for the PRISM award for photonics innovation because of its' stability, compact size, low cost/performance ratio, wide spectral range and high power. The BeST-SLED ® is a multiple superluminescent diode light source within a single butterfly package that provides up to 50mW of power over the spectral band of 1230nm to 1730nm ...

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    2. Heidelberg Engineering and Gauss Medical Corporation Establish an Ophthalmic Healthcare IT Joint Venture in China

      Heidelberg Engineering and Gauss Medical Corporation Establish an Ophthalmic Healthcare IT Joint Venture in China

      The joint venture company, Gauss Infomed, will offer Picture Archiving and Communication Systems (PACS) and Electronic Medical Record (EMR) software, along with other related product solutions for the ophthalmology healthcare IT market. Gauss Infomed will operate out of Beijing and through a local network of offices to deliver its services across the entire country. “China is a fast-growing market and it is of great importance to our company” “The establishment of this joint venture with Heidelberg Engineering comes at a time of growing demand for advanced ophthalmic IT solutions in China,” said Mr. Liu Xidong, Chairman and CEO of Gauss ...

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    3. Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen

      Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen

      Technology Upgrade to Lightbox L250 Allows Physicians to Accurately Assess Luminal Gain REDWOOD CITY, Calif., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures ...

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    4. OCT Angiography Module for SPECTRALIS now available outside US

      OCT Angiography Module for SPECTRALIS now available outside US

      The SPECTRALIS ® expandable diagnostic imaging platform can be upgraded with the OCT Angiography Module to perform non-invasive, layer-by-layer examinations of flow in the vascular networks of the retina and choroid. The OCT Angiography Module can be added to new and existing upgradeable SPECTRALIS devices with the OCT2 Module. The multimodal imaging platform allows clinicians to compare OCT angiographies to other modalities such as structural OCT and dye-based angiographies as well as infrared, MultiColor and BluePeak images, dependent on the SPECTRALIS model. “In combination with other imaging modalities, OCT angiography enables a more comprehensive understanding of vascular abnormalities. The SPECTRALIS truly ...

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    5. Micro-Tech LumiScan Imaging System 510(k) Clearance

      Micro-Tech LumiScan Imaging System 510(k) Clearance

      We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions ...

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      Mentions: FDA Micro-Tech
    6. Wasatch Photonics MicroAngio, 2017 Prism Award Finalist

      Wasatch Photonics MicroAngio, 2017 Prism Award Finalist

      Wasatch Photonics Inc., a leading provider for gratings, spectrometers and optical coherence tomography instrumentation, is pleased to announce its new 3D MicroAngio technology has been selected as a Prism Award Finalist in the highly competitive Biomedical Instrumentation category. WP MicroAngio was created for high-resolution angiographic imaging for research and original equipment manufacturer (OEM) applications. Unlike other OCT angiography systems, the WP MicroAngio offers custom probe designs for each specific application, such as retina, brain or skin, for the highest quality images. WP software drives the system and provides both 3D images and one-click options for sampling, processing and motion correction ...

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    7. ZEISS receives the first US FDA Clearance for Swept-Source OCT posterior ocular imaging with PLEX Elite 9000

      ZEISS receives the first US FDA Clearance for Swept-Source OCT posterior ocular imaging with PLEX Elite 9000

      Having received the first US FDA Clearance for OCT Angiography technology in September 2015, the Medical Technology business group of ZEISS now announces receiving the first US FDA Clearance for Swept-Source OCT imaging technology for posterior ocular structures with ZEISS PLEX ® Elite 9000. This powerful, cutting-edge Swept-Source OCT and OCT Angiography platform was designed for advanced retina research and is at the core of the Advanced Retina Imaging (A R I) Network 1 . The A R I Network, led by Philip J. Rosenfeld, MD, PhD, is a unique global consortium of clinicians and scientists from around the world working at ...

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    8. NinePoint Medical Announces Substantial Hospital Reimbursement Increase for Procedures Using the NvisionVLE Imaging System with Real-time Targeting

      NinePoint Medical Announces Substantial Hospital Reimbursement Increase for Procedures Using the NvisionVLE Imaging System with Real-time Targeting

      NinePoint Medical, Inc., a transformative medical device company pioneering the use of an advanced imaging platform for gastrointestinal applications, announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has published its 2017 final fee schedule. The annual update includes a material increase to the reimbursement rate for CPT Code 43252 1 ( upper GI endoscopy with optical endomicroscopy ), used for esophageal procedures using the NvisionVLE Imaging System with Real-time Targeting. According to the final 2017 CMS fee schedule, starting January 1, 2017, the reimbursement rate for CPT code 43252 in the hospital out-patient setting increases 131% from $1 ...

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    9. HS-UK launch Optovue’s innovative DualTrac and Vault Mapping technology in the UK

      HS-UK launch Optovue’s innovative DualTrac and Vault Mapping technology in the UK

      DualTrac Motion Correction is a unique technology which provides motion correction at two levels. It combines video tracking and Motion Correction Technology (MCT) to enable true 3D tracking. The first level provides real-time correction for rapid eye movements, blinking or eye drifting, which improves patient comfort. The second level occurs during post-processing of imaging and corrects smaller levels of motion distortion. This combined approach results in reliable motion correction for patients who have trouble directing their focus on a central point during an eye exam and is essential for high-quality OCT-A imaging. Jacqui Kenyon, HS-UK Product Manager, said, “This new ...

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    10. Avinger Launches Upgraded Lightbox Imaging Console

      Avinger Launches Upgraded Lightbox Imaging Console

      Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the U.S. launch of an enhanced version of the company’s Lightbox imaging console. The Lightbox provides a dual display of images to physicians using Avinger’s Lumivascular system, the first-ever image-guided atherectomy and chronic total occlusion (CTO) recanalization devices for the treatment of peripheral artery disease (PAD), providing physicians with a view inside diseased arteries. The upgraded Lightbox L250 console is designed to be more intuitive, provide sharper imaging, and reduce start-up times before procedures begin. Physician feedback and a commitment ...

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    11. With FDA nod, Avinger's PAD device becomes both therapeutic and diagnostic tool

      With FDA nod, Avinger's PAD device becomes both therapeutic and diagnostic tool

      The FDA expanded the indication of Avinger’s image-guided atherectomy device for the treatment of peripheral artery disease, allowing its use in both therapeutic and diagnostic procedures. Now, the Pantheris device may be used for diagnostic imaging and treatment of PAD simultaneously. It is the first and only image-guided atherectomy system to be cleared for both, according to a statement. In addition to using the device for atherectomy--a catheter-based treatment that removes plaque from a blood vessel--physicians may also use it to identify features of blood vessels, including necrotic cores, fibroatheromas, calcium and stent struts. Being able to see from ...

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    12. Avinger Announces Expanded FDA Indications for Pantheris™ as Diagnostic Imaging Device

      Avinger Announces Expanded FDA Indications for Pantheris™ as Diagnostic Imaging Device

      Avinger, Inc. (NASDAQ: AVGR ), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received expanded indications from the U.S. Food and Drug Administration (FDA) recognizing the Pantheris™ Lumivascular atherectomy system as a technology that can be used for both therapeutic and diagnostic purposes. Pantheris is the first and only image-guided atherectomy device to receive clearance for diagnostic imaging as well as for the simultaneous treatment of PAD. This expanded indication clarifies that, in addition to treatment of PAD, Pantheris may be used by physicians to identify the vessel lumen and wall ...

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    13. LLTECH Records Major Progress In Prostate Cancer Detection And Diagnosis On Use Its Cellular-Scale Imaging Solution

      LLTECH Records Major Progress In Prostate Cancer Detection And Diagnosis On Use Its Cellular-Scale Imaging Solution

      LLTech, an imaging company specialized in the field of the real-time optical biopsy for the diagnosis and the assessment of cancer surgery, announces today the publication of a new study demonstrating the potential of its Full-field optical coherence tomography (FFOCT) technology in the pre-histological detection of prostate cancer. During a study led to the Beijing Hospital of Health Ministry (Beijing, China), Cochin Hospital (Paris, France) and UCLA (Los Angeles, USA), three readers (a pathologist with previous experience with FFOCT, a pathologist new to FFOCT, and a urologist new to FFOCT) were trained to read FFOCT images of prostate biopsies (a ...

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    14. Optovue launches OCTA in optometry

      Optovue launches OCTA in optometry

      Optovue introduced AngioVue, a noninvasive 3-D visualization of retinal blood flow, as an addition to its conventional OCT, here at Vision Expo West . Optovue’s senior director of U.S. sales, Joe Garibaldi, told Primary Care Optometry News that this conference represented the product’s launch in optometry. With AngioVue, “You’re getting fluorescein angiography-like results and indocyanine green results,” Garibaldi said, in 5 seconds, with no injections. He noted that the technology is a software upgrade to the Avanti OCT. The company also announced the launch of Vault Mapping software, an addition to its iVue/iFusion and iScan OCT ...

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      Mentions: Optovue
    15. UC SD Health Center Using Tiny Optic Camera for Peripheral Artery Disease Patients

      UC SD Health Center Using Tiny Optic Camera for Peripheral Artery Disease Patients

      A catheter equipped with a tiny fiber optic camera is now being used at UC San Diego Health to treat patients with peripheral artery disease , a build-up of plaque that blocks blood flow in the arteries of the legs and feet, it was announced Monday. The technology, approved by federal authorities in March, has been used on 10 patients so far at the Sulpizio Cardiovascular Center. UCSD Health said it is the only medical group in San Diego using the device, which allows physicians to see inside arteries for the first time, and by using the visual cues, remove plaque ...

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      Mentions: Avinger
    16. New Catheter Lets Doctors See Inside Arteries for the First Time

      New Catheter Lets Doctors See  Inside Arteries for the First Time

      Cardiologists at Sulpizio Cardiovascular Center at UC San Diego Health are the first in the region to use a new, high-tech catheter that allows them to see inside arteries for the first time — cutting out only the diseased tissue. The new technology is used to remove plaque from clogged arteries, a procedure that can save and improve lives. Cardiologist Dr. Mitul Patel The new image-guided device, Avinger’s Pantheris Lumivascular atherectomy system, allows doctors to see and remove plaque simultaneously during an atherectomy – a minimally invasive procedure that involves cutting plaque away from the artery and clearing it out to ...

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      Mentions: FDA Avinger
    17. Heidelberg receives FDA clearance to market Spectralis OCT glaucoma module

      Heidelberg receives FDA clearance to market Spectralis OCT glaucoma module

      Heidelberg Engineering received 510(k) clearance from the FDA to market the Spectralis OCT Glaucoma Module Premium Edition, which creates an anatomic map unique to each patient’s eye. The module provides clinicians with objective and automatic measurement parameters for increased diagnostic accuracy, according to a company press release. It utilizes a new technology called Anatomic Positioning System, which uses the center of the fovea and the center of Bruch’s membrane opening to create an anatomic map of the eye. Each scan thereafter is automatically oriented according to each patient’s unique anatomic eye map. In addition, the module ...

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    18. Heidelberg Engineering Receives FDA Clearance to Market SPECTRALIS® OCT Glaucoma Module Premium Edition

      Heidelberg Engineering Receives FDA Clearance to Market SPECTRALIS® OCT Glaucoma Module Premium Edition

      The Glaucoma Module Premium Edition for SPECTRALIS provides a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics. By means of a new proprietary technology called the Anatomic Positioning System, the module creates an anatomic map unique to each patient’s eye using two fixed, structural landmarks: the center of the fovea and the center of Bruch’s membrane opening. All subsequent scan protocols are automatically oriented according to each eye’s unique anatomic map, enabling a precise examination ...

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    19. SP Devices launches the world’s first 14-bit resolution digitizer for Optical Coherence Tomography (OCT) applications - e2v

      SP Devices launches the world’s first 14-bit resolution digitizer for Optical Coherence Tomography (OCT) applications - e2v

      SP Devices, an e2v company, has launched the ADQ14OCT, the first 14-bit digitizer for Swept-Source (SS) Optical Coherence Tomography (OCT) that offers unrivalled noise and distortion performance. Built on SP Devices’ original 14-bit digitizer, the ADQ14OCT has been optimised for the SS-OCT market through variable clock input compatability of 10-1000 MHz and the addition of embedded signal processing functions in the Field-Programmable Gate Array (FPGA). These changes facilitate a simplified system design that increases overall system performance to match the most challenging measurement situations. The ADQ14OCT utilizes the longest embedded Fast Fourier Transform (FFT) in OCT digitizers and sustains streaming ...

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      Mentions: e2v
    20. Optovue Launches Vault Mapping at Vision Expo West for Scleral Contact Lens Fitting

      Optovue Launches Vault Mapping at Vision Expo West for Scleral Contact Lens Fitting

      Optovue, the global leader in the development of optical coherence tomography (OCT) and OCT angiography (OCTA), introduced Vault Mapping for all iSeries OCT systems this week at the International Vision Expo West , Sept. 15-17. The new Vault Mapping software can be used to assist in scleral lens fitting by allowing visualization and mapping of the central corneal clearance (CCC), a key measurement related to how well the lens rests on the eye. Optovue also introduced its proprietary AngioVue™ Imaging System to the optometry market and announced two in-booth presentations -- one on Vault Mapping by Jeffrey Sonsino, OD, and one on ...

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      Mentions: Optovue
    21. Compact Imaging to Demonstrate Sub-dermal Fingerprint for Presentation Attack Detection At GIS2016 in Tampa

      Compact Imaging to Demonstrate Sub-dermal Fingerprint for  Presentation Attack Detection At GIS2016 in Tampa

      Compact Imaging, Inc., a Silicon Valley company developing small, low-cost optical sensors for the rapidly growing biometric security, personal health monitoring and non-destructive testing (NDT) markets, today announced that it will demonstrate its MRO™ subsurface scanning technology at the Global Identity Summit 2016 (GIS2016), Sept. 19-22, in Tampa. Compact Imaging's breakthrough MRO™ (Multiple Reference OCT) technology brings non-invasive OCT (optical coherence tomography) depth scanning to high volume field applications that require small size and low cost, such as biometric collection systems. Previously, OCT had been limited by its large size, high cost and extreme complexity in clinical and laboratory ...

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    22. Avinger Signs Agreement with HealthTrust for Lumivascular Technology

      Avinger Signs Agreement with HealthTrust for Lumivascular Technology

      Avinger, Inc. (NASDAQ: AVGR ), a developer of innovative treatments for peripheral artery disease (PAD), today announced it has signed an agreement with HealthTrust. The agreement establishes terms under which members of the HealthTrust group purchasing organization may acquire Avinger’s portfolio of technologies designed to treat PAD, including Avinger’s Pantheris TM Optical Coherence Tomography (OCT) image-guided atherectomy system, which recently received 510(k) clearance from the United States Food & Drug Administration (FDA). The agreement becomes effective September 15, 2016. Pantheris is a minimally invasive treatment for peripheral artery disease in which a catheter-based device is used to remove plaque ...

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      Mentions: FDA Avinger
    23. Avinger Signs Agreement with U.S. Department of Veterans Affairs for Lumivascular Technology

      Avinger Signs Agreement with U.S. Department of Veterans Affairs for Lumivascular Technology

      Avinger, Inc a developer of innovative treatments for peripheral artery disease (PAD), today announced the company has received an FSS Contract Award from the U.S. Department of Veterans Affairs (VA) which establishes terms under which VA hospitals across the country may acquire Avinger’s portfolio of Optical Coherence Tomography (OCT) image-guided catheters for their veterans hospitals. VA operates the nation's largest integrated health care system, with more than 1,700 hospitals, clinics, community living centers, domiciliaries, readjustment counseling centers, and other facilities. “We’re thrilled that our Lumivascular technologies will now be available to the men and women ...

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    24. Optovue Announces DualTrac Motion Correction Technology for Faster, Improved Imaging

      Optovue Announces DualTrac Motion Correction Technology for Faster, Improved Imaging

      Company to Host Educational Symposium on OCT Angiography Optovue, the global leader in the development of optical coherence tomography (OCT) and OCT angiography (OCTA), today announced the availability of DualTrac™ Motion Correction technology on the AngioVue™ Imaging System at the 34th Annual Scientific meeting of the American Society of Retina Specialists (ASRS) in San Francisco (Booth #801). DualTrac Motion Correction is a two-level approach to correcting motion artifact on patients who have difficulty focusing on a central visual point during an eye exam, which is essential for high-quality OCTA imaging. According to David Sarraf, M.D., Clinical Professor of Ophthalmology ...

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