FDA 510 (k) clearance—FluoroShield (Omega Medical)
Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy.
FDA approval—Stellarex 0.035 in sizes 200mm and 150mm (Philips)
Philips has added two new balloons to its portfolio of Stellarex 0.035 low-dose drug-coated balloons, following approval from the FDA. The new 200mm and 150mm Stellarex 0.035 low-dose balloons are now approved and available, in the USA, for the treatment of de novo and restenotic lesions in native superficial femoral or popliteal arteries. A press release reports that the balloons will be rolled out to other markets in “due course”.