Medical Devices

icotec ag's VADER® Pedicle System Navigated Instruments Gain FDA 510(k) Clearance for Safer Spinal Implantation

icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants....

RIVANNA Secures $30.5M from BARDA to Advance Accuro XV Musculoskeletal Imaging

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software....

Hyderabad's RICH Concludes Medical Device & IVD Commercialisation Workshop Series

A month-long awareness and hands-on workshop series called “ABCs of Medical Devices and In-vitro Diagnostics (IVDs) Commercialisation Journey” came to a successful end. It was attended by aspiring entrepreneurs, researchers, start-ups, MSMEs, SMEs, and industry players. This was the first edition of this workshop series by Research and Innovation Circle of Hyderabad (RICH)....

Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support crit...

Alma Veil™ Launched in the U.S. Market by Sisram Medical's Alma

Alma, a global leader in the energy-based medical and aesthetic solutions industry, proudly announces the commercial availability of Alma Veil™. This advanced, dual-wavelength vascular laser workstation establishes a new standard in excellence by optimizing efficiency with remarkable efficacy across a comprehensive range of vascular and dermatological conditions....

Japan's Omron Healthcare breaks ground on new manufacturing plant in India

The new manufacturing plant will commence operations by March 2025...

Noise launches first Smart Ring to consolidate leadership in health wearables

Luna Ring comes with 70+ metrics and industry-best features to augment healthspan...

Inspira™ Technologies Receives Medical Devices Quality Certification, Progresses Towards EU Regulatory Approval

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it has received International Organization for Standardization (ISO) 13485:2016 Standard Certification, which is the international standard for quality management systems within the medical device industry, and a requirement for EU regulatory approval....

Nesa Medtech gets US FDA clearance for fibroid mapping reviewer application

Novel SaMD technology generates a 3D model of uterus to facilitate treatment in patients with symptomatic uterine fibroids...