Company Product Description Indication Status
Bio-Rad Laboratories Inc., of Hercules, Calif. SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit Molecular test that runs on Bio-Rad's QX200 and QXDx ddPCR systems For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nasal and mid-turbinate nasal swab specimens as well as nasopharyngeal wash/aspirate and nasal aspirate specimens Received emergency use authorization from the U.S. FDA
Euroimmun U.S. Inc., a Perkinelmer Inc. company, of Mountain Lakes, N.J. Anti-SARS-CoV-2 ELISA (IgG) serology test Serology IgG test For the qualitative detection of IgG antibodies against SARS-CoV-2 in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) Received emergency use authorization from the U.S. FDA
Lifesignals Group Inc., of Fremont, Calif. Lifesignals ECG Remote Monitoring Patch Disposable wireless remote monitoring system For continuous collection of electrocardiography and heart rate monitoring in ambulatory, hospital, healthcare and home settings Received CE mark
Nuvasive Inc., of San Diego Modulus ALIF Porous titanium implant For the anterior lumbar interbody fusion (ALIF) procedure Received 510(k) clearance from the U.S. FDA
Nuvasive Inc., of San Diego Cohere TLIF-O Porous PEEK implant For the transforaminal lumbar interbody fusion (TLIF) procedure Received 510(k) clearance from the U.S. FDA
Vitalconnect Inc., of San Jose, Calif. Vitalpatch Wireless, biosensor technology Detects changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19 Received emergency use authorization from the U.S. FDA

Notes

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

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