Company Product Description Indication Status
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

Notes

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