North America

i-Lumen Randomises First US Patient in Dry AMD Bioelectric Therapy Study

The i-SIGHT2 pivotal trial is evaluating a noninvasive office-based bioelectric therapy for intermediate to advanced dry age-related macular degeneration. ...

AlloSource Introduces FDA-Cleared Pre-Sutured Tendon for ACL Reconstruction

ReConnex is designed to reduce operating room preparation time and variability in all-inside anterior cruciate ligament procedures. ...

LifeLens Gains FDA Clearance for Expanded Wearable Vital Sign Monitoring

The clearance expands the LifeLens Physiological Monitor beyond ECG acquisition to include respiratory, temperature, activity and gait parameters. ...

AcuityMD Now Trusted By More Than 500 Medical Device Companies, Including 16 of Top 20

Rapid growth reflects seismic shift toward greater use of AI across the MedTech industry...

Urology Health Introduces AI-Enabled Platform to Address U.S. Urologic Care Gaps

New virtual-first approach helps millions get faster, easier treatment for common conditions...

Fresenius Medical Care introduces TherapyWise analytics for ICU kidney therapy

The cloud-based tool gives hospitals retrospective programme-level insights into kidney replacement therapy delivered in acute and critical care settings....

BIOTRONIK Neuro Launches Embrace One Proactive Intelligence

Data presented at ASPN demonstrate the AI model's ability to identify patients who may benefit from support, often before they recognize a problem themselves...

ASCP Awards Grants to Six Organisations to Improve Precision Care for Metastatic Colorectal Cancer

Six health systems and organizations awarded funding to improve patient access to cancer care through optimizing molecular testing pathways, biomarker-driven treatment selection, and precision oncology implementation in metastatic colorectal cancer...

HoneyNaps gains FDA clearance for AI sleep-disordered breathing software

SOMNUM V3.0 supports automated analysis of polysomnography data and classifies obstructive, central and mixed sleep apnea events....

Spark Biomedical study supports non-invasive neurostimulation for bleeding control

The first-in-human study showed that wearable auricular neurostimulation enhanced platelet function without systemic effects or adverse events....