North America

Lupin Receives Approval from U.S. FDA for Ranluspec (ranibizumab) Injection

Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A...

Subtle Medical Receives FDA Clearance for AI-Powered PET Image Enhancement Software

SubtleHD(PET) supports all FDA-approved radiotracers and enables up to 75 percent faster PET imaging on existing PET/CT and PET/MR scanners. ...

OrthAlign Receives FDA Clearance for Lantern ASC Orthopaedic Navigation System

The handheld navigation platform is designed for ambulatory surgery centres, offering an alternative to higher-cost robotic systems for knee procedures. ...

Zepto Life Technology Receives FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test

The FungiFlex Mould Panel is currently available for physician ordering through Zepto Life Technology's CLIA-certified laboratory as a Laboratory Developed Test (LDT)...

Mindray expands Hepatus-Series ultrasound systems for gastroenterology imaging

The upgraded Hepatus-Series integrates ultrasound and elastography to support liver, bowel and spleen assessment within a unified imaging workflow....

Dr Nancy Amoia highlights NightLase laser treatment for snoring and mild sleep apnea

The laser-based treatment offers a minimally invasive option for selected patients seeking to reduce snoring and improve nighttime breathing without sedation, appliances or downtime....

Pictor Labs advances virtual staining workflows for integrated tissue analysis

The company’s ClearStain and ReStain platforms aim to support tissue preservation, molecular workflow efficiency and multi-omic research by generating virtual stains from unstained or existing H&E slides....

United Imaging Spotlights Molecular Imaging Showstoppers at SNMMI 2026

The company is expanding its presence in the North American market by introducing new members of the uMI Panvivo family...

Sysmex America Introduces XR-Series Hematology Solution for Clinical Laboratories

The next-generation hematology platform builds on the XN-Series with higher throughput, enhanced analytics and modular workflow support for high-complexity laboratories. ...

Gene Solutions Receives FDA Breakthrough Device Designation for SPOT-MAS 10 Cancer Screening Test

The designation supports Gene Solutions’ US development pathway for its multi-omic blood-based test designed to detect cancer-associated signals across 10 cancer types. ...