Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Ensite X EP system Cardiac mapping system Provides navigation for cardiac ablation procedures Received the CE mark
Abbott Laboratories, of Abbott Park, Ill. Ensite X EP system Cardiac mapping system Provides navigation for cardiac ablation procedures Received approval from Australia's Therapeutic Goods Administration
Biolytical Laboratories Inc., of Richmond, British Columbia Insti HIV self test Fingerstick test Allows individuals to screen and monitor for HIV in their own home Received Health Canada approval
DNA Genotek Inc., an Ottawa, Ontario-based subsidiary of Orasure Technologies Inc. Oracollect∙RNA (OR/ORE-100) saliva collection device Double-ended tube cap with attached integrated sponge For the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA Received emergency use authorization from the U.S. FDA allowing for the unsupervised use of the device at-home or in a health care setting when used as a component of an authorized or cleared self-collection kit
Pari Pharma GmbH, of Starnberg, Germany Lamira nebulizer system Aerosol delivery system based on Eflow Technology For the administration of Arikayce Liposomal 590 mg Nebuliser Dispersion (Insmed Inc., Bridgewater, N.J.) Received the CE mark
Salvia Bioelectronics BV, Eindhoven, Netherlands Implantable neurostimulation system Bioelectronics solution For drug-refractory chronic migraine Received breakthrough device designation from the U.S. FDA

Notes

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