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LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (“STAAR” or the “Company”) (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced the appointment of Andrew Pilon, O.D. as Vice President of Business Development. Dr. Pilon will report to STAAR President and Chief Executive Officer Warren Foust and will work closely with the Company’s senior leadership team to capitalize on opportunities th...

LONDON--(BUSINESS WIRE)--AviadoBio Presents New Safety and Biomarker Data from the Phase 1/2 ASPIRE-FTD Trial at the International Conference on Frontotemporal Dementias...

BOCA RATON, Fla.--(BUSINESS WIRE)--SurGenTec®, a privately held medical device company focused on advancing treatment options for orthopedic and spine surgery, today announced that it has entered into an exclusive license agreement with Allevion Medical for its patented Vantage™ spinal decompression technology. Under the terms of the agreement, SurGenTec® has secured exclusive rights to Allevion Medical's Vantage™, a fully disposable, sterile system designed to simplify and enhance minimally in...

NEW YORK--(BUSINESS WIRE)--VB Spine will showcase its xvision X2 headset and Vulcan Spinal System at the North American Spine Society’s 41st Annual Meeting....

HOUSTON--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has accepted XCath’s Iris Surgical Robotic System into its Total Product Life Cycle Advisory Program (TAP) Pilot, the company announced today. The system is intended for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. XCath is a medical device company advancing endovascular surgical robotics, and the FDA’s decision comes after it granted Breakthrough Device Designation to the Iris Syste...

TORONTO--(BUSINESS WIRE)--ClaroNav Kolahi Inc. (CKI), ein weltweit tätiger Entwickler und Hersteller von chirurgischen Navigationstechnologien, gab heute bekannt, dass sein chirurgisches Navigationssystem „Navient“ die Zertifizierung gemäß der Medizinprodukteverordnung der Europäischen Union (EU-MDR) erhalten hat. Die Zertifizierung umfasst das bildgestützte Navigationssystem Navient sowie dessen wiederverwendbare chirurgische Instrumente und ermöglicht es CKI, Navient im gesamten Gebiet der Eu...

TORONTO--(BUSINESS WIRE)--ClaroNav Kolahi Inc. (CKI), azienda internazionale specializzata nello sviluppo e nella produzione di tecnologie di navigazione chirurgica, oggi ha annunciato che il suo Navient Surgical Navigation System ha ricevuto la certificazione UE del Regolamento sui Dispositivi Medici (MDR). La certificazione copre il Navient Image Guided Navigation System e i suoi strumenti chirurgici riutilizzabili, consentendo a CKI di continuare a offrire Navient in tutta l'Unione europea n...

TORONTO--(BUSINESS WIRE)--A ClaroNav Kolahi, Inc. (CKI), empresa global de desenvolvimento e fabricação de tecnologias de navegação cirúrgica, anunciou hoje que seu Sistema de Navegação Cirúrgica Navient obteve certificação sob o Regulamento de Dispositivos Médicos da União Europeia (MDR da UE). Essa certificação abrange o sistema de navegação guiada por imagem Navient e seus instrumentos cirúrgicos reutilizáveis, permitindo que a CKI continue oferecendo o Navient em toda a União Europeia, de a...

多伦多--(BUSINESS WIRE)--(美国商业资讯)-- 全球外科导航技术开发商和制造商ClaroNav Kolahi Inc.（CKI）今日宣布，其Navient外科导航系统已获得欧盟医疗器械法规（EU MDR）的认证。 该认证涵盖Navient图像引导导航系统及其可重复使用的手术器械，使CKI能够在EU MDR的监管框架下，继续在整个欧盟范围内提供Navient产品。 CKI首席执行官Ahmad Kolahi表示，获得EU MDR认证是CKI的一个重要里程碑，彰显了我们持续致力于满足安全、质量和法规遵从性方面最高标准的承诺。” Navient此前已通过EU MDD认证，并获得了包括美国FDA、加拿大卫生部、中国国家药品监督管理局（NMPA）和日本药品医疗设备综合机构（PMDA）在内的监管机构批准。目前，Navient已在全球70多个国家/地区投入使用，全球累计安装量超过250套系统。 在脊柱外科领域，CKI通过引入FluoroGuide 2D以及其市场首创的CT/MRI与荧光透视配准技术，进一步扩展了Navient平台，将术前CT和MRI与术中2D荧光透视技术相结合，从而实...

TORONTO--(BUSINESS WIRE)--ClaroNav Kolahi Inc. (CKI), desarrollador y fabricante mundial de tecnologías de navegación quirúrgica, anunció hoy que su sistema de navegación quirúrgica Navient ha obtenido la certificación conforme al Reglamento sobre Productos Sanitarios de la Unión Europea (MDR de la UE). La certificación abarca el sistema de navegación guiada por imagen Navient y sus instrumentos quirúrgicos reutilizables, lo que permite a CKI seguir ofreciendo Navient en toda la Unión Europea b...