Company Product Description Indication Status
Accuray Inc., of Sunnyvale, Calif. Clearrt Helical Kvct Imaging Imaging solution for the Radixact treatment delivery system For soft tissue visualization in cancer patients receiving radiation therapy Received 510(k) clearance from the U.S. FDA
Bioserenity SAS, of Paris Neuronaute EEG system Acquires, displays, stores and transmits electroencephalography (EEG) signals from the brain; remote access is facilitated via the Neuronaute N-Cloud Allows physicians to remotely monitor and assess electrical brain activity of people with epilepsy Received 510(k) clearance from the U.S. FDA
Bioserenity SAS, of Paris Icecap EEG wearable device Single-use disposable electrode cap; used with the Neuronaute EEG system Enables the recording of short interval (less than 1 hour) EEG for routine or emergency brain activity assessments Received 510(k) clearance from the U.S. FDA
Nirmidas Biotech Inc., of Palo Alto, Calif. Midaspot COVID-19 antibody combo detection kit Point-of-care serology test For the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum and plasma Received emergency use authorization from the U.S. FDA
Spark Biomedical Inc., of Dallas Sparrow therapy system Wearable neurostimulation device Provides opioid withdrawal relief Received 510(k) clearance from the U.S. FDA
Trinity Biotech plc, of Bray, Ireland Captia SARS-CoV-2 IgG ELISA Enzyme-linked immunosorbent assay (ELISA) Detects IgG antibodies to SARS-CoV-2 Received CE mark approval

Notes

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