Author: Jorg Lorscheider

MARLBOROUGH, Mass.–(BUSINESS WIRE)—- $HOLX #Bacterial–Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial pathogens res

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/PRNewswire/ — Smartlens, Inc., a clinical-stage ophthalmic technology company advancing next-generation glaucoma management devices, today announced the…

An important milestone in the company’s mission to deliver precision-engineered orthopedic solutions BRECKSVILLE, OH, UNITED STATES, October 16, 2025 /EINPresswire.com/ — Auxano® Medical is proud to announce its wedge fixation system, ARKEO™, has received U.S. Food and Drug Administration (FDA) 510(k) clearance, marking an important milestone in the company’s mission to deliver precision-engineered orthopedic solutions that empower surgeons and improve patient outcomes. The ARKEO™ Wedge Fixation System integrates an anatomical design with the pillared microstructure of the Auxano® in-growth technology to provide a secure fixation interface at the site of correction. Designed for use in Evans and Cotton osteotomies, the ARKEO™ surgical set includes intuitive instrumentation that enhances reproducibility by giving surgeons complete control over implant positioning throughout the procedure. “Achieving 510(k) clearance for ARKEO™ represents a significant advancement in our orthopedic portfolio,” said Joe Harr, Sales & Distribution Manager at Auxano® Medical. “This system combines modern engineering with practical, surgeon-focused innovation to deliver reproducible results and improve the surgical experience.” The ARKEO™ system is designed to optimize fixation and graft integration through several key features: • Anatomical Fit: Subflush placement reduces irritation and maintains alignment. • Open Architecture: Large central graft cavity and thru-growth fenestrations maximize graft capacity and promote biologic fixation. • Controlled Stability: The unique pillared surface morphology has demonstrated viability in scientific research studies and clinical efficacy in midfoot fusion applications. • Intuitive Instrumentation: Simplifies each step for efficient, consistent outcomes. Supplied non-sterile in a steam-sterilizable tray, the ARKEO™ system includes a Hintermann distractor, k-wires, osteotomes, mallet, slap hammer, implant trials, inserter, and an impactor. “The ARKEO™ Wedge Fixation System exemplifies Auxano® Medical’s commitment to designing devices that are both clinically advanced and intuitively engineered,” shared Dr. George Picha, Ph.D, F.A.C.S. “With this clearance, we are proud to continue expanding our solutions for orthopedic surgeons across the U.S.” For more information about the ARKEO™ Wedge Fixation System, visit www.AuxanoMedical.net or contact CS@AuxanoMedical.net.About Auxano® Medical Auxano® Medical develops and manufactures advanced orthopedic solutions that support improved patient outcomes and procedural efficiency. With a commitment to quality, innovation, and clinical collaboration, Auxano® delivers technologies that meet the highest standards of performance and reliability. The company is headquartered near Cleveland, OH. For more information, visit www.auxanomedical.net Halle SchosslerAuxano Medicalemail us here Legal Disclaimer: EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

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