Medical Devices

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. ...

Galvanize Therapeutics Secures FDA Clearance for Aliya EX Generator

The clearance expands Galvanize’s pulsed electric field portfolio for soft tissue ablation, supporting broader lesion treatment and limited US commercial release. ...

PorTal Access Completes FDA Submission for Flexi-Port Ahead of Planned Commercial Launch

The submission moves PorTal Access closer to a planned mid-summer launch, positioning Flexi-Port as a differentiated vascular access solution for oncology and long-term infusion therapy. ...

Sky Labs Secures UK MHRA Approval for Ring-Type Blood Pressure Monitor Platform

Sky Labs’ ring-type wearable blood pressure monitor, ‘CART BP pro’, has already established a dominant presence in its home market...

Asia Summit on Global Health and Hong Kong International Medical and Healthcare Fair Conclude Successfully

Over 1,000 investment and business matching meetings, MoUs to support healthcare enterprises to go global ...

Cepheid Receives CE Marking Under IVDR for Xpert GI Panel

IVDR-compliant PCR test supports the detection of 11 clinically relevant gastrointestinal pathogens from 1 sample...

JenaValve Appoints Dave Haan as Vice President of Clinical Affairs

Dave brings more than 25 years of executive leadership experience in medical devices, with particular depth in interventional and catheter-based therapies, regulatory strategy...