Medical Devices & Implant

Preat Corporation Launches PreatLoc Overdenture Attachment System

An overdenture attachment system providing compatibility, reliability and precise performance...

Spinal Resources Strengthens IP Portfolio with New Bezier Rod Patent

The patent's focus on a constant-slope transition ensures a gradual and predictable stiffness profile...

Polarean Expands Xenon MRI Platform into Cardiopulmonary Drug Development with Multi-Centre PH-ILD Study

Polarean is working in collaboration with VIDA Diagnostics (VIDA), providing centralised imaging operations, site orchestration, and advanced Xenon MRI biomarker analysis...

Amplifi Vascular Gains FDA Breakthrough Device Status & CMS Category B

The Breakthrough Device Designation is a distinction reserved for technologies that offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases...

HAI Solutions Receives FDA De Novo Grant for QIKCAP System

This marks the first and only FDA-Granted Ultraviolet light-based microbial reduction device for luer-activated valves, establishing a new Class II medical device category...

Overture Orthopaedics Announces Milestone $1.0Mn in Sales of its OvertureTi Knee Resurfacing System

OvertureTi Knee Resurfacing System implants are designed specifically as an alternative when it is still too early for arthroplasty...

CapsoVision Announces Submission for Addition of AI-Assisted Reading Module in CapsoCam Plus

CapsoVision’s CapsoCam Plus capsule endoscopy system is intended for visualisation of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years and older...

Enable Injections Announces Regulatory Approval in Saudi Arabia for EMPAVELI Injector

This regulatory clearance in Saudi Arabia complements the Company’s broader global strategy...

Bone Biologics Improves Extension of rhNELL-1 Product Shelf Life to 24 Months

Milestone advances manufacturing readiness and supports long-term commercialization strategy...

2025 Biological Device Application Approvals. How FDA Clearances Are Reshaping Blood Banking, Diagnostics, and Point of Care Medicine

From blood bank software and immunohematology analysers, to HIV diagnostics and platelet rich plasma systems, the 2025 approval landscape signals a clear shift towards automation, safety, traceability, and point of care innovation across transfusion and laboratory medicine...