North America

Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment Tool

Embryo Predict provides fertility specialists with adjunctive AI insight for embryo selection during IVF, supported by a multicentre randomised clinical trial. ...

Clarius Receives FDA Clearance for AI-Based Ejection Fraction Ultrasound Tool

The app-integrated tool automates left ventricular ejection fraction assessment, supporting real-time cardiac evaluation in primary care and emergency settings. ...

Waters Secures FDA Clearance for BD BACTEC FXI Blood Culture System

The automated system is now available in the US, offering faster bloodstream infection detection and higher vial-loading capacity for high-throughput microbiology laboratories. ...

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....