|Advanced Medtech Holdings, of Singapore||Resolute 2.0 direct RT-PCR test kit||RT-PCR test that eliminates the need for viral RNA extraction from patient test samples||Detects SARS-CoV-2||Received approval from Australia's Therapeutic Goods Administration|
|DNA Genotek Inc., an Ottawa, Ontario-based subsidiary of Orasure Technologies Inc.||Omnigene·ORAL (OME-505)||Saliva collection device; allows for at-home self-collection of samples||For use as a component in molecular diagnostic tests for the detection of SARS-CoV-2||Received Health Canada authorization|
|Global Instrumentation LLC, of Manlius, N.Y.||M5 Recorder||Wearable electrocardiogram (ECG) sensor||Records ECG data remotely in patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety||Received 510(k) clearance from the U.S. FDA|
|Perspectum Ltd., of Oxford, U.K.||Hepatica||Artificial intelligence-based tool that uses quantitative multiparametric MRI||Provides clinical and surgical decision support for patients with liver cancer||Received 510(k) clearance from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.