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Medical Devices & Implant

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...

Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device

Innovative single-device solution integrates proven FemVue and FemChec technologies to support fallopian tube evaluation and improve workflow efficiency...

Nyxoah Launches Genio Breakthrough Therapy in the Netherlands

First Genio implants successfully performed at OLVG West and Zuyderland hospitals...

Advita Ortho Wins Innovation Award for Soft Tissue Balancing in Knee Replacement Surgery

Newton provides ligament-driven balance by combining a force-controlled intra-articular tensioner with GPS...

Healthium Medtech Acquires Controlling Stake in Paramount Surgimed

The non-surgical business of Paramount, including its lifestyle and hygiene business, will be carved out before the transaction and retained with the Grover family...