Company Product Description Indication Status
Endologix Inc., of Irvine, Calif. Alto Abdominal stent graft system Endovascular treatment of abdominal aortic aneurysms Received the CE mark
Eyenuk Inc., of Los Angeles Eyeart Autonomous artificial intelligence system Automatically detects more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in eyes of adults diagnosed with diabetes Received 510(k) clearance from the U.S. FDA
Life Spine Inc., of Huntley, Ill. Plateau-A Ti Anterior Lumbar Spacer system For anterior fusion procedures Received 510(k) clearance from the U.S. FDA
Neumodx Molecular Inc., of Ann Arbor, Mich., and Sentinel Diagnostics, of Milan, Italy Quantitative BKV assay PCR test For the quantitative detection of BK virus (BKV) Received the CE mark
Roche Group, of Basel, Switzerland Cobas EBV test Real-time polymerase chain reaction viral load test with dual target technology; runs on the Cobas 6800/8800 systems For the quantitative, in vitro detection of Epstein-Barr virus (EBV) DNA U.S. FDA granted de novo class II authorization
Siemens Healthineers AG, of Erlangen, Germany Somatom Mobile head computed tomography (CT) scanner Enables a critically ill patient to receive CT head imaging in the intensive care unit while remaining in bed Received 510(k) clearance from the U.S. FDA


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

No Comments