The FDA approved the Enhanced LumiGuide Guidewire from Philips and the ECGuide from Piccolo Medical.

Philips announced that the FDA has approved the enhanced 160cm version of its LumiGuide Navigation Wire, which uses Fiber Optic RealShape (FORS) technology. This milestone coincides with the 1000th patient treated with Philips’ 3D real-time device guidance technology. Dr. Carlos Timaran, an internationally known vascular surgeon, used the new wire to perform a complex aortic repair.

The extended LumiGuide wire provides US clinicians with broader catheter visualization, allowing for faster, more accurate procedures with less radiation. FORS technology enables 3D color visualization of catheters and guidewires, revolutionizing endovascular surgery by cutting procedure times by 37% and radiation by 70%.

Piccolo Medical has received FDA clearance for their ECGuide™ Connector, a component of the PM2™ System. This new catheter guidance technology uses electrocardiogram (ECG) to determine catheter tip position in real time, providing a safer alternative to chest X-rays for verifying central venous catheter placement.

The FDA-approved ECGuide™ technology addresses limitations in current catheter guidance systems for Central Venous Catheter (CVC) procedures. Although similar systems are used for Peripherally Inserted Central Catheters (PICCs), their use in CVC procedures is limited. The innovation by Piccolo Medical aims to improve catheter insertion accuracy and safety.

The ECGuide™ technology aims to reduce complications and costs by providing real-time guidance during central venous catheter insertions, potentially improving patient outcomes.