Company Product Description Indication Status
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

Notes

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