Medical Devices

Wellysis Secures FDA Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI

Adds FDA-cleared AI analysis to Wellysis' S-Patch ECG monitoring solution, expanding its capabilities beyond ECG acquisition...

Lupin Receives U.S. FDA Approval for Phytonadione Injectable Emulsion, USP

The U.S. FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD)...

Terumo launches K-Pack Embrace active safety needle globally

The needle combines hard-shell packaging for automated co-packing with an integrated hinged safety shield designed to reduce needlestick injuries....

HAI Solutions Advances AI-Enabled IV Connector Care with New US Patent

QIKcap System: QIKcap is HAI Solutions' ultraviolet platform for needle-free IV connectors, built to support more consistent connector care in the hospital...

AIRS Medical Receives FDA Clearance for SwiftSight Body Composition

SwiftSight Body Composition is designed around a scan of less than five minutes, followed by automated AI analysis...

Aevice Health gains FDA clearance for AI-powered wheeze detection software

The Class II decision-support software analyses lung sound recordings from compatible FDA-cleared electronic stethoscopes and flags recordings suggestive of wheeze for clinical review....

AcuityMD brings prescription data into AcuityAI to help MedTech reps identify new patient opportunities

The AI platform combines prescription and procedure data in a single workflow, helping commercial teams prioritise HCPs treating patients who may be candidates for medical devices....

Europe has the tools to improve sickle cell care, but access gaps persist

Terumo Blood and Cell Technologies’ Hidden Struggle barometer compares seven European health systems on treatment access, workforce training, registries, newborn screening and national coordination....

Accuray and Samsung NeuroLogica Advance Volumetric Imaging Collaboration

The collaboration represents another example of Accuray's strategy to address customer priorities through targeted partnerships that bring together complementary expertise...

AI can help imaging services do more with existing workforce and infrastructure: Ari Wood

Ari Wood, Acting Head of Imaging, Australia and New Zealand and Head of CT/AMI, Growth Region at Philips, discusses how AI-enabled MRI and CT technologies can address rising imaging demand, workforce constraints and regional access gaps across Australia and New Zealand....