Regulatory

Ten stakeholders jointly seek recall of India's New Drugs, Cosmetics & Medical Devices Bill 2023

Indian medical device manufacturers, patient interest groups, users and hospitals write to Union Health Minister Dr Mansukh L Mandaviya...

India launches first indigenously developed Magnetic Resonance Imaging (MRI) Scanner

Voxelgrids Innovations has developed the MRI Scanner under the National Biopharma Mission of Department of Biotechnology...

Singapore unveils Industry Transformation Map 2025 for healthcare

Renewing focus on primary and preventive health in medical training...

A dispute between industry & government's opinion on medtech sector?

Unfortunate to see PM’s ‘Make in India’ dream being bulldozed: AiMeD...

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....

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...

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

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

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...