🎉 Wishing our readers, advertisers and collaborators a purposeful and prosperous 2026. Thank you for being part of our journey as we continue to inform, inspire and build impact together in the year ahead. 🎉 🎉 Wishing our readers, advertisers and collaborators a purposeful and prosperous 2026. Thank you for being part of our journey as we continue to inform, inspire and build impact together in the year ahead. 🎉

Regulatory

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...

ALC Pune Launches CRE-2025 to Advance Amputee Rehabilitation in India

CRE-2025 aims to advance holistic amputee care and strengthen India’s rehabilitation landscape through structured training, knowledge exchange, and innovation...

Axogen Announces FDA Approval of Biologics License Application for AVANCE

Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities...

Olympus Initiates Global Removal of ViziShot 2 FLEX Needles Following Safety Reports

The voluntary action affects devices manufactured before May 12, 2025, after reports of component detachment linked to patient injuries and one death, with Olympus reinforcing safeguards to prioritise patient safety....

Techsomed Secures FDA 510(k) Clearance for BioTraceIO360 Kidney Ablation Indication

The expanded clearance extends BioTraceIO360 beyond liver applications to kidney procedures, advancing Techsomed’s vision of a multi-organ, AI-driven image-guided therapy platform that standardises minimally invasive cancer care....

Tasso-SNBL Secures Japanese Certification for Self-Collection Blood Kit

Breakthrough approval supports home-based testing and strengthens access to care...

Abbott’s Navitor™ Wins CE Mark Expansion, Offering Minimally Invasive Valve Replacement to Low- and Intermediate-Risk Patients in Europe

Backed by VANTAGE trial data unveiled at ESC Congress 2025 and published in JACC: Cardiovascular Interventions, Navitor now covers all surgical risk categories—while new ESC/EACTS guidelines also strengthen support for MitraClip™ and TriClip™ in mitral and tricuspid valve disease management....

Conformal Medical Raises $32M to Advance Next-Gen Stroke Prevention Device

Funding boost to support pivotal trial and pre-commercialization of CLAAS® AcuFORM™ LAAO system. ...

Dräger Atlan A350 Series Earns Highest U.S. Cybersecurity Clearance for Medical Devices

Authority to Operate (ATO) certification from the U.S. Department of Defense affirms Dräger’s leadership in safeguarding patient data, delivering a fully ATO-certified anesthesia portfolio trusted by hospitals worldwide....