Wednesday, 24 September 2025

Regulatory

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....

DeepSight™ Technology Receives First FDA 510(k) Clearance for NeedleVue™ LC1 Ultrasound System

Bringing Clarity and Confidence to Ultrasound-Guided Interventional Procedures ...

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....

Bracco Imaging’s SonoVue® Secures NMPA Approval for HyCoSy Use in China, Enhancing Non-Invasive Infertility Diagnostics

Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women. ...

Body Vision Medical Secures HSA Approval for AI-Powered LungVision Platform in Singapore

Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics....

BMI OrganBank Secures FDA Breakthrough Device Designation for Innovative Kidney Transplant Technology

BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys...