Coronavirus company news summary - Vela Diagnostics’ Covid-19 test receives CE mark - FDA issues EUA for gammaCore Sapphire nVNS - Verdict Medical Devices
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Coronavirus company news summary – Vela Diagnostics’ Covid-19 test receives CE mark – FDA issues EUA for gammaCore Sapphire nVNS

14 Jul 2020 (Last Updated July 14th, 2020 09:35)

Vela Diagnostics has received the European CE mark for in vitro diagnostic use of the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, a Covid-19 detection test. The test also received Provisional Authorisation from the Singapore’s Health Sciences Authority. It is a probe-based reverse transcription polymerase chain reaction (PCR) test that specifically targets the ORF1a and N genes of the SARS-CoV-2 genome to detect infection.

National Tsing Hua University Institute of Biomedical Engineering’s Professor Cheng Chao-Min has developed a new Covid-19 test that enables a physician to offer treatment on time to high-risk patients. The test was developed in partnership with the Tri-Service General Hospital and the prototype is undergoing the clinical validations at different medical centres.

Helix has partnered with San Diego County to increase the availability of Covid-19 testing across the county for those who require it the most. Under the public-private partnership, San Diego County will be provided with around 2,000 Helix Covid-19 Test, a RT-PCR test, daily.

electroCore has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of gammaCore Sapphire CV non-invasive vagus nerve stimulation (nVNS) to treat adult patients who are confirmed or suspected to have Covid-19. The nVNS will be used for patients who are suffering from asthma-related dyspnea and reduced airflow and drug therapies do not offer symptom relief.