Medical Devices

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 510(k) 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...

Neurolief to Showcase At-Home Brain Stimulation Therapy for Major Depressive Disorder at APA 2026

The company will present Proliv Rx, its FDA-approved physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded adequately to antidepressant medication. ...

Mopec Group Introduces Cortex Systems to Strengthen Connected Pathology Workflows

The new technology division will serve as Mopec Group’s innovation hub, supporting digital tools that improve workflow efficiency, documentation and integration across the pathology continuum. ...

Caracal’s Strata Glove Receives Greenhealth Approved Seal

The recognition places Caracal’s nitrile examination glove within a vetted category of medical products meeting sustainability and safer chemical criteria for healthcare procurement. ...

Aurie Receives FDA De Novo Grant for Reusable Intermittent Catheter System

The FDA marketing authorisation establishes a new Class II device category for Aurie’s automated reusable no-touch intermittent urinary catheter system, with launch planned in Veterans Health Administration spinal cord injury hospitals later this year. ...