From FDA clearances to touting study data, here are some medtech stories we missed this week but thought were still worth mentioning.
1. XpandOrtho wins FDA 510(k) clearance
XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of thickness and tibial component.
2. Visionsense goes after Novadaq patent
Visionsense has filed an IPR with the USPTO for its Novadaq Technologies’ U.S. patent, according to a May 16 press release. The patent is for a method for using fluorescence angiography to assess patency of vessel grafts. It is the only patent that Novadaq lists on its website as being associated with the SPY Elite system.
3. FDA clears Body Vision Medical’s LungVision navigation system
Body Vision Medical announced in a May 15 press release that it received FDA clearance to market its LungVision imaging system that enables accurate, real-time navigation and lesion localization during bronchoscopy procedures. LungVision has gone through clinical trials in the U.S., where it has been shown to be a sophisticated augmented reality approach for physicians to visualize, plan and track endobronchial tools and radiolucent lesions in real-time. The system also uses intraoperative fluoroscopy and pre-operative high-resolution imaging.