Company Product Description Indication Status
Augmedics Ltd., of Yokneam Illit, Israel Xvision Spine system Augmented reality guidance system; transparent near-eye-display headset Allows surgeons to visualize the 3D spinal anatomy of a patient during surgery and accurately navigate instruments and implants Received 510(k) clearance from the U.S. FDA
Cryolife Inc., of Kennesaw, Ga. On-X aortic valve Mechanical heart valve Surgical aortic valve replacement; approved for use with warfarin for anticoagulation Received U.S. FDA authorization to commence the PROACT Xa clinical trial; will investigate if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban (Eliquis) rather than warfarin
Curetis NV, of Holzgerlingen,
Unyvero lower respiratory tract application cartridge Molecular diagnostic For use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia Received 510(k) clearance from the U.S. FDA
Life Spine Inc., of Huntley, Ill. Titanium stand-alone ALIF spacer system Comes in footprints of 34 mm x 24 mm, 38 mm x 28 mm and 42 mm x 30 mm; there are 3 lordotic options of 6°, 12° and 18° and heights ranging from 11-17 mm; the screws allow for stand-alone use of the system and offer angulation up to 45° For the surgical treatment of spinal disorders Received 510(k) clearance from the U.S. FDA


For more information about individual companies and/or products, see Cortellis.

No Comments