Medical Devices

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...

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...

Cornerstone Robotics Secures EU CE Mark and Singapore HSA Certification for Sentire Surgical System

Dual regulatory approvals grant the surgical robotics platform access to European and Asia-Pacific markets for minimally invasive procedures across multiple specialties....

Healium Registers Clinical VR Biofeedback Platform as FDA Class II 510(k)-Exempt Device

The registration positions Healium Clinical for wider use in healthcare settings as a prescription-use immersive biofeedback, neurofeedback and relaxation training application. ...

MedTech Innovator Asia Pacific Names Top 20 Startups for 2026 Accelerator

Selected from more than 680 applicants, the cohort will enter the eighth APAC Accelerator Program with access to mentorship, industry partners, investors and market access support. ...