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....
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....
Breakthrough approval supports home-based testing and strengthens access to care...
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....
Bringing Clarity and Confidence to Ultrasound-Guided Interventional Procedures ...
Funding boost to support pivotal trial and pre-commercialization of CLAAS® AcuFORM™ LAAO system. ...
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....
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. ...
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 is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys...