|Boston Scientific Corp., of Marlborough, Mass.||Wavewriter Alpha portfolio||Spinal cord stimulator systems with MRI conditional, Bluetooth-enabled implantable pulse generators||Provides relief for chronic pain||Received U.S. FDA approval|
|Etiometry Inc., of Boston||Etiometry Platform||Clinical decision support software||Provides valuable clinical insight and analysis to support early recognition of subtle changes in patient condition||Received 510(k) clearance from the U.S. FDA for two enhancements: Selectable Risk Index Thresholds and Measurement Contributions|
|Modulim, of Irvine, Calif.||Clarifi||Optical imaging system that uses spatial frequency domain imaging||For assessing tissue and microvascular function by quantitatively mapping tissue oxygenation and perfusion at the point-of-care||Received the CE mark|
|Nico.Lab BV, of Amsterdam||Strokeviewer LVO||Artificial intelligence algorithm||Detects image characteristics associated with a large vessel occlusion (LVO) and alerts physician||Received 510(k) clearance from the U.S. FDA|
|Roche Diagnostics Inc., of Indianapolis||Elecsys Anti-SARS-CoV-2 S antibody test||Serology test||For the qualitative and semi-quantitative detection of antibodies to SARSCoV-2 in human serum and plasma; for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection||Received emergency use authorization from the U.S. FDA|
|University of California Los Angeles and the University of California San Francisco||Gallium 68 PSMA-11 (Ga 68 PSMA-11)||Radioactive diagnostic agent; administered in the form of an intravenous injection||For positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer||Received U.S. FDA approval|
For more information about individual companies and/or products, see Cortellis.