Article Name Medical Devices & Implant

Positron Corporation Secures Multiple PET-CT Orders from Leading Nuclear Cardiologist Practices

These new customer engagements underscore the adoption of Positron’s next-generation PET-CT technology and comprehensive services solution

18th February, 2026


InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device

The approval, known as a CE Mark, allows the company's InVera Infusion Device to be marketed and used across the European Union

17th February, 2026


Explant Express Receives FDA Clearance for Breast Implant Suction Retrieval Device

FDA-cleared suction retrieval device designed to streamline breast implant removal and reduce mess, handling, and operating time

13th February, 2026


Berlin Heals Raises $10Mn to Expand the New Less Invasive Approach to More Heart Failure Patients

Berlin Heals has developed a novel therapeutic approach for the treatment of heart failure based on its proprietary implantable device

12th February, 2026


Bracco and ACIST Medical Systems Announce European Launch of ACIST Pro Diagnostic System

Next-generation variable-rate contrast management system designed to advance precision, safety, and efficiency in image-guided cardiovascular procedures

12th February, 2026


Amsino International Signs Three-Year Supply Partnership with Partners Cooperative

The partnership ensures consistent product availability and enhances supply reliability for Partners members amidst ongoing supply-chain challenges across the healthcare industry

04th February, 2026


Cynosure Lutronic Announces Completion of EU MDR Approval and Global Momentum for Mosaic 3D

Mosaic 3D represents the next generation of non-ablative fractional laser, offering to deliver more energy and cover more areas

02nd February, 2026


Olympus Announces U.S. Launch of the SecureFlex Single-Use Fine Needle Biopsy Device

Olympus' newest needle for endoscopic ultrasound-guided biopsy is designed to offer precision sampling when access matters most

29th January, 2026


Preat Corporation Launches PreatLoc Overdenture Attachment System

An overdenture attachment system providing compatibility, reliability and precise performance

28th January, 2026


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

23rd January, 2026


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

21st January, 2026


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

14th January, 2026


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

02nd January, 2026


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

31st December, 2025


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

30th December, 2025


Enable Injections Announces Regulatory Approval in Saudi Arabia for EMPAVELI Injector

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

29th December, 2025


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

Milestone advances manufacturing readiness and supports long-term commercialization strategy

26th December, 2025


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

26th December, 2025


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