1. Articles in category: Other Business News

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    1. Efficacy of Notal Vision Home OCT demonstrated by a series of scientific and clinical work

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      Efficacy of Notal Vision Home OCT demonstrated by a series of scientific and clinical work

      Notal Vision, Inc. reported today that numerous scientific and clinical publications and presentations prove the feasibility and efficacy of their patient-operated, home-based optical coherence tomography (OCT) device. As part of a comprehensive remote monitoring service, which includes a monitoring center and artificial intelligence algorithms for information processing, the Notal Home OCT effectively monitors wet age-related macular degeneration (AMD) treatment between doctor’s office visits. Wet AMD is the leading cause of blindness in people over 50 in the United States. Several treatments have been developed over the last two decades and have proven to be extremely beneficial. However, therapy requires ...

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      Mentions: FDA Notal Vision

    2. Avinger Expands International Presence with First Commercial Shipment to Chile

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      Avinger Expands International Presence with First Commercial Shipment to Chile

      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 expansion of its international presence with the commercial launch of its Lumivascular products in Chile. Avinger's new Lightbox 3 imaging console will be used exclusively to support the launch of the Lumivascular platform in Chile. To support the entry into this new international market, Avinger has signed an exclusive distribution agreement with Importadora y Distribuidora Arquimed Ltda for the sale and marketing of Avinger's proprietary Lightbox 3 imaging ...

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    3. Medical Device Optics from Shanghai Optics

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      Medical Device Optics from Shanghai Optics

      Optics is playing a key role in nearly every modern diagnostic advance, and devices that rely on optics are extensively used for medical research, diagnostics and treatment. Shanghai Optics is proud to manufacture high quality optics for medical devices and applications, and we are able to work with your team to design and produce custom medical device optics to fit your specific needs. Our optics are used in medical and clinical research laboratories worldwide, in medical diagnostic applications (including micro endoscopy, optical coherence tomography (OCT), and PCR instruments), and medical treatment applications such as robotic surgery, and laser based ophthalmology ...

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    4. Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

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      Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

      The Food and Drug Administration has categorized Abbott Laboratories’ recall of 4,800 Dragonfly OpStar Imaging Catheters as a Class I event, reflecting the potential for a problem with the device that could lead to vascular injuries. Abbott issued an urgent notice about the catheters last month to warn customers of the risk of proximal markers separating from the devices. At the time, the company had received five complaints including one case of an embolism that required further intervention. According to the FDA’s Thursday notice, no deaths have been associated with the use of the device due to the ...

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      Mentions: Abbott FDA

    5. Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

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      Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

      Abbott has recalled its Dragonfly OpStar imaging catheter, used for imaging the coronary arteries with optical coherence tomography, due to the possibility that the marker band farthest from the tip of the catheter could become loose and harm the patient, the US Food and Drug Administration announced Thursday . The recall has been deemed Class I, the most serious type. The issue has been associated with five incidents and one injury, but no deaths. In two cases, the loose band separated completely from the catheter while it was in use. If that happens and the band remains behind in the patient ...

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      Mentions: Abbott FDA

    6. OncoRes Medical raises another $12.5M

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      OncoRes Medical raises another $12.5M

      OncoRes Medical announced that it raised $12.5 million for its handheld imaging device for identifying cancer cells. Perth, Western Australia-based OncoRes designed its imaging system to facilitate real-time tumor assessment, helping surgeons more accurately identify and remove cancerous tissue, including for breast cancer . The company won FDA breakthrough device designation in October 2020 for the device aimed at enabling surgeons to remove all cancer on the first try, thus avoiding a second procedure. When the handheld probe is applied to a region of interest, it provides micro-scale maps of the stiffness of the tissue — a key differentiator from healthy ...

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      Mentions: FDA OncoRes Medical

    7. Uncover scientific innovations with Heidelberg Engineering at ARVO 2022

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      Uncover scientific innovations with Heidelberg Engineering at ARVO 2022

      Heidelberg Engineering presents various scientific innovations at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) Heidelberg Engineering showcases its research capabilities at this year’s ARVO congress that takes place in Denver, Colorado, USA, from May 1–4. The team looks forward to reconnecting with the global research community after two years of solely virtual ARVO meetings, and to demonstrating various scientific innovations and state-of-the-art technologies at the Heidelberg Engineering booth (#2412). The research technologies shown cover a wide range of applications – from retina diagnostics and glaucoma research, cellular and metabolic imaging, to anterior segment ...

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      Mentions: Heidelberg Engineering

    8. Digital Angiography Reading Center (DARC)/WorldCare Clinical Adds Voxeleron To Analysis Pipeline

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      Digital Angiography Reading Center (DARC)/WorldCare Clinical Adds Voxeleron To Analysis Pipeline

      DARC Continues Investment in Best-in-Class Ophthalmology Service with Orion™ by Voxeleron OCT Image Analysis Software Voxeleron, a cloud-based platform provider that analyzes and tracks all formats of ophthalmic data, announced today that Digital Angiography Reading Center (DARC) / WorldCare Clinical has selected Orion by Voxeleron for use in image analysis. Orion is a vendor-neutral platform that analyzes OCT images from multiple devices within a common platform, significantly consolidating and minimizing the reading center’s requirements for software and devices. Orion's automated centration and segmentation software, including unique editing features, offer increased accuracy with an intuitive interface to reduce errors while ...

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      Mentions: Voxeleron

    9. Conavi Medical’s Novasight Hybrid System Now In Use at Sunnybrook Health Sciences Centre

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      Conavi Medical’s Novasight Hybrid System Now In Use at Sunnybrook Health Sciences Centre

      Conavi Medical Inc. ( www.conavi.com ), a leader of hybrid imaging guidance for common minimally invasive heart procedures, and Sunnybrook Health Sciences Centre , today announced that the Novasight Hybrid System is now being used for clinical procedures by interventional cardiologists as part of the Schulich Heart Program. Sunnybrook’s Schulich Heart Program is one of Canada’s leading cardiac and vascular care centres with an international reputation for pioneering some of the world’s most innovative ways to diagnose and treat the heart and damaged blood vessels. The hybrid intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging platform, now ...

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      Mentions: University of Toronto Sunnybrook Health Sciences Centre FDA

    10. Desmond Adler Becomes President of Cardiovascular at Gentuity LLC

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      Desmond Adler Becomes President of Cardiovascular at Gentuity LLC

      Desmond Adler becomes President of Cardiovascular at Gentiuity, LLC. Dr. Adler is a Biomedical executive, team builder, and strategic innovator with a 20-year track record of commercial success in highly competitive markets. Developed and launched multiple disruptive products in ophthalmology, cardiology, and gastroenterology including drug-device combination therapies and imaging systems. Key contributor to two acquisitions ($90M and $497M) and one IPO ($245M) in the last 10 years. He left is position of General Manager and VP of R&D, Corneal Health, at Glaukos Corporation.

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      Mentions: Gentuity

    11. Ontario Government Makes Strategic Investments in Conavi Medical

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      Ontario Government Makes Strategic Investments in Conavi Medical

      The Ontario government is supporting investments of more than $10 million by two Ontario companies with $5 million through the Ontario Together Fund. These projects will help to grow local manufacturing capacity, accelerate the commercialization of domestic life sciences innovations, and strengthen the province’s pandemic preparedness while creating 22 new, local jobs. “The Ontario Together Fund is helping Ontario businesses to fully develop their ideas and innovate in our diverse life sciences sector,” said Vic Fedeli, Minister of Economic Development, Job Creation and Trade. “Our government is proud to partner with companies like Conavi Medical and ventureLAB as they ...

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      Mentions: Conavi Medical Inc.

    12. Luneau takes on global name of Visionix

      Explore Healio.com Ophthalmology , Other Business News
      Luneau takes on global name of Visionix

      Luneau Technology Group announced at Vision Expo East that Visionix is its new global name. Visionix is now a “house of brands,” Milbien Medina , Visionix senior director of brand marketing North America, told Healio. As of March 31, Visionix encompasses the formerly individual brands of Luneau Technology , Briot, Weco, Visionix, Next Sight and Optovue, Medina said. The new company will now oversee manufacturing, sales and service for all brands. At Vision Expo East, Visionix also introduced the Eye Refract and VX650 combination system that can provide a full eye exam in 10 minutes, Medina said. The second-generation Eye Refract is ...

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      Mentions: Visionix

    13. New Cylite CEO Eyes $4.8B Global Eye Care Opportunity

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      New Cylite CEO Eyes $4.8B Global Eye Care Opportunity

      Kylee Hall has been appointed Chief Executive Officer of Cylite, the Australian company responsible for designing and manufacturing the award-winning Hyperparallel optical coherence tomography device (HP-OCT) which provides advanced three-dimensional imaging of the eye. Ms Hall, who is known for delivering products into the medical and ophthalmic markets, takes the reigns from renowned scientist Dr Steve Frisken who will continue, in an executive leadership role, to provide operational and innovation guidance to the company. Ms Hall believes Cylite is well positioned to make a global impact in the AU$4.8 billion eyecare diagnostics industry. “Despite the challenges of COVID ...

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    14. Luneau Technology Launches as “Visionix” to Manufacture and Sell Optovue, Visionix, Briot and Weco Brands

      Explore Home | InvisionMag.com Ophthalmology , Other Business News
      Luneau Technology Launches as “Visionix” to Manufacture and Sell Optovue, Visionix, Briot and Weco Brands

      Luneau Technology Group recently announced that it will take on “Visionix” as its official global name beginning March 31, 2022, unveiling a combined booth at Vision Expo East. As mentioned in the recent global announcement, “Optovue” will transition to a product brand for Visionix’s OCT and OCTA line.

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      Mentions: Visionix

    15. Wasatch Photonics introduces compact, lightweight OCT spectrometer for integration into OEM imaging systems

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      Wasatch Photonics introduces compact, lightweight OCT spectrometer for integration into OEM imaging systems

      Wasatch Photonics has expanded its Cobra OCT spectrometer product line with a new OCT spectrometer designed specifically for ease of integration by OEMs into OCT imaging systems. The Cobra OEM is a small size and low weight spectrometer optimized for 800 nm spectral domain OCT (SD-OCT) imaging, and is based on a configurable optomechanical bench engineered for volume manufacturing. It builds on the company’s existing line of Cobra OCT spectrometers, expanding their application in turnkey systems for ophthalmology and eye surgery, materials processing and laser welding, and industrial inspection of surface topology and microelectronics packaging. The Cobra OEM OCT ...

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      Mentions: Wasatch Photonics

    16. Scinvivo Closes an Investment Round of 1 Million Euro from NextStage Early Stage Fund

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      Scinvivo Closes an Investment Round of 1 Million Euro from NextStage Early Stage Fund

      Scinvivo, a MedTech startup based in Eindhoven, has closed an investment round of 1 Million Euro from NextStage Early Stage Fund (NSESF), Innovatiefonds Noord-Holland and current shareholders. With this investment Scinvivo has secured the development of in human clinical trials and CE certification. Scinvivo is on a mission to make cancer diagnostics faster and more accurate, enabling reduction of unnecessary surgeries and improving the quality of patients' lives. Scinvivo develops an imaging platform based on a forward looking OCT catheter to visualise the human morphological tissue structure a few mm’s deep with a high resolution.This approach fills the ...

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    17. Siloton Announces C.£470K Investment Round

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      Siloton Announces C.£470K Investment Round

      Siloton Limited , a revolutionary new deep-tech startup, has announced the first closing of its investment round, totalling c.£470k. The funds will be used to further develop Siloton’s diagnostic imaging technology. By harnessing the power of photonic integrated circuits (PICs), this is set to revolutionise the way in which patients with eye disease interact with ophthalmology services. In addition to attaining key technology milestones, Siloton will seek to form partnerships with key stakeholders and members of the global supply chain. The round was led by Quantum Exponential Group PLC and Evenlode Impact who invests to build a diversified start-up ...

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    18. Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

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      Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

      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 the U.S. have successfully completed first cases with its new Lightbox 3 imaging console. The Lightbox 3 received 510(k) pre-marketing clearance from the U.S. Food & Drug Administration (FDA) in January. Avinger is expanding availability of the Lightbox 3 to additional sites on a limited basis and anticipates progressing to full commercial availability early in the second quarter of 2022. Over the past week, Dr. Jaafer ...

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    19. Dyad Medical Secures FDA Clearance for Intravascular OCT Image Analysis Platform

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      Dyad Medical Secures FDA Clearance for Intravascular OCT Image Analysis Platform

      Dyad Medical, Inc. , the developer of the cloud-based AI technology for cardiac image analysis called Libby™, announced that the U.S. Food and Drug Administration (FDA) has cleared Libby™ IAAA through the 510(k) pathway. Libby™ IAAA offers image analysis used for viewing and quantifying Intravascular Optical Coherence Tomography (IVOCT) images. The clearance provides healthcare professionals another important tool to automate intravascular investigation, or the ability to see the inside of blood vessels. “Dyad Medical is proud to offer hospital systems, imaging centers, and researchers a tool to conduct cardiac image analysis in a fraction of the time,” said Dr ...

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      Mentions: FDA Dyad Medical

    20. Mirrorcle Technologies concludes successful SPIE Photonics West 2022

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      Mirrorcle Technologies concludes successful SPIE Photonics West 2022

      The world leading manufacturer of MEMS-based optical beam-steering products and system solutions, Mirrorcle Technologies, announces the successful completion of the first live, in-person, Photonics West after the cancellation of the 2021 show. Finally, SPIE was held again at the Moscone Center in San Francisco, attracting more than 3200 technical attendees and almost 3000 exhibition visitors from around the world. Mirrorcle’ presence, in addition to exhibiting its products on the show floor, included the presentation of an academic paper on recent developments surrounding the company’s patented gimbal-less MEMS mirrors and how they will enable robotics solutions, as well as the ...

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    21. Conavi Medical Plans for Strategic Expansion in U.S. Market

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      Conavi Medical Plans for Strategic Expansion in U.S. Market

      Conavi Medical Inc., a leader of hybrid imaging guidance for common minimally invasive heart procedures, plans to expand the presence of its Novasight Hybrid System in the U.S. market in 2022 under the guidance of its new leadership team. Thomas Looby, chief executive officer, Conavi Medical, appointed in April of 2021 to focus on the company’s strategic growth plans, has set the U.S. market as the company’s near-term focus. Looby’s extensive background in leading medical device companies and developing global markets for cutting-edge technology bolsters the leadership team as they prepare for new milestones. To ...

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      Mentions: FDA Conavi Medical Inc.

    22. Heidelberg Engineering Supports “Glaucoma / Myopia OCT Phenotyping Consortium”

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      Heidelberg Engineering Supports “Glaucoma / Myopia OCT Phenotyping Consortium”

      Heidelberg Engineering is serving as a member of the Glaucoma / Myopia OCT Phenotyping Consortium (GMOPC), in a new effort to support research to improve the detection of glaucoma, the world´s leading cause of irreversible vision loss. The GMOPC was established in February 2020 at an inaugural meeting in Los Angeles, California, as an investigator-initiated clinical research study, with Heidelberg Engineering as an industry partner. The consortium comprises 13 clinical centers in seven countries and provides a new research platform for acquiring OCT images, data storage and retrieval for efficient review, quality control and secure access. Looking beyond established risk ...

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      Mentions: Heidelberg Engineering Devers Eye Institute

    23. Avinger Announces $7.6 Million Registered Direct Offering

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      Avinger Announces $7.6 Million Registered Direct Offering

      Avinger, Inc. (NASDAQ:AVGR) (the "Company"), 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 it has entered into a definitive agreement with certain institutional investors for the issuance and sale in a registered direct offering of an aggregate of 7,600 shares of Series D convertible preferred stock (the "Preferred Stock") and warrants to purchase up to an aggregate of 16,150,000 shares of common stock for gross proceeds of $7.6 million. The shares of Preferred Stock will have a ...

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      Mentions: Avinger

    24. PhotoniCare Announces ISO 13485:2016 Certification

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      PhotoniCare Announces ISO 13485:2016 Certification

      PhotoniCare, Inc.—a company revolutionizing frontline care with the OtoSight Middle Ear Scope that uses OCT technology to increase the objective accuracy of fluid assessment in the middle ear—announced that they have successfully completed their ISO 13485:2016 certification today. ISO 13485:2016 is an internationally recognized quality standard that specifies requirements for a quality management system used by an organization demonstrating its ability to provide medical devices and related services that consistently meet strict regulatory and customer requirements. The Quality Management System PhotoniCare utilizes to design, manufacture, and service OtoSight Middle Ear Scopes has officially been audited and ...

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      Mentions: National Institutes of Health PhotoniCare
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