Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. SARS-CoV-2 IgG II Quant antibody test Lab-based serology test Detects levels of IgG antibodies that attach to the virus' spike protein on the virus surface in serum and plasma Received the CE mark
Abbott Laboratories, of Abbott Park, Ill. Panbio COVID-19 Ag Rapid test device that uses a lateral flow assay Detects the SARS-CoV-2 virus Received approval from Colombia's National Institute for Food and Drug Surveillance
Anitoa Systems LLC, of Sunnyvale, Calif. Maverick series Portable real-time PCR instruments Detects DNA from infectious diseases Received the CE-IVD mark
Binx Health Inc., of Boston At-Home Nasal Swab COVID-19 Sample Collection
Kit
For self-collection of nasal swab specimens at home For use with an in vitro diagnostic molecular test for the detection of SARS-CoV-2 RNA that is indicated for use with the collection kit The U.S. FDA amended its emergency use authorization to allow for centralized specimen collection kit distribution and retrieval by large partners
Ellume Ltd., of East Brisbane, Australia Ellume COVID-19 Home Test A rapid, lateral flow immunoassay that involves the premixing and binding of fluorophore specific to SARS-CoV-2; used with mobile app to provide instructions and display results For the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs Received emergency use authorization from the U.S. FDA; first fully at-home test authorized for nonprescription use
Exero Medical, of Or Yehuda, Israel Smart sensor Implantable biodegradable wireless sensor For early detection of anastomotic leaks following gastrointestinal surgery Received breakthrough device designation from the U.S. FDA
Genetesis Inc., of Mason, Ohio Cardioflux Biomagnetic imaging technology For diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome Received breakthrough device designation from the U.S. FDA; previously cleared by the FDA as a general tool to noninvasively measure and display the magnetic signals produced by the electric currents of the heart
Horiba Medical, of Irvine, Calif. Yumizen C1200 Next-generation clinical chemistry system For lab test processing Received U.S. FDA clearance
Horiba Medical, of Irvine, Calif. Yumizen C1200 Next-generation clinical chemistry system For lab test processing Received Health Canada clearance
Roche Group, of Basel, Switzerland Cobas PIK3CA Mutation Test PCR-based test Detects PIK3CA mutations in patients with metastatic breast cancer to help identify those most likely to benefit from approved therapy Received the CE mark
Seaspine Holdings Corp., of Carlsbad, Calif. Nanometalene Surface technology that incorporates a submicron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process For interbody devices Received 510(k) clearance from the U.S. FDA for amended indication
Switch Health Solutions Inc., of Toronto COVID-19 At-Home Collection Kits For self-collection of specimens at home; used with Switch Health's videoconferencing software, Asmo For asymptomatic individuals who require COVID-19 testing for work, travel or desire regular screening Received Health Canada authorization

Notes

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