Medical Devices

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. ...

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. ...

MedTech Innovator Announces 2026 Asia Pacific Accelerator and U.S. Market Access Cohorts

The 2026 programme features 20 APAC accelerator companies and six Singapore-based startups selected for U.S. market access support...

Yuanhua Tech’s KUNWU Orthopaedic Robot Completes First International Clinical Surgery in Brazil

The China-developed surgical robot supported a total knee replacement in a Brazilian public hospital, demonstrating its open-platform compatibility with local prosthesis systems. ...

Brain Navi Receives TFDA Certification for KrystoLens Neuro-Endoscope

The Taiwan certification clears the way for KrystoLens’ local market entry, supporting Brain Navi’s commercialisation strategy in minimally invasive neuro-endoscopic imaging. ...

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. ...

Align Technology Plans $200 Million Manufacturing Facility in Hyderabad

The planned facility will be Align’s first manufacturing site in India and is expected to support Asia-Pacific operations, supply chain resilience and growing Invisalign demand. ...

Stryker Launches Pangea Plating System in Europe Following First Clinical Case

The trauma fixation platform is designed to support anatomical fit, simplified instrumentation and flexible fracture fixation across upper and lower extremities. ...

Oticon Medical Expands Ponto Portfolio with Instant HearBand and SoundConnector

The Ponto Instant portfolio includes Softband 5, Oticon Medical’s established and trusted non-surgical solution...

Sky Labs Achieves Global First with Guideline Recognition for Cuffless BP Monitoring Technology

This inclusion in the treatment guidelines is also an innovative change, drawing attention from the global hypertension academic community...