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May 11, 2020

Coronavirus company news summary – Vitagene announces 50,000 FDA approved at home COVID-19 test kits – Aidoc receives FDA authorisation for cleared AI algorithms

By Chloe Kent

Quidel has received the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen FIA. Sofia 2 is a ‘rapid point-of-care test’ that has to be used with the Sofia 2 Fluorescent Immunoassay Analyzer, which will help in detecting the presence of SARS-CoV-2 in nasopharyngeal or nasal specimens.

Precision health company Vitagene has announced that 50,000 FDA authorised ‘Zero Contact’ at home COVID-19 test kits are available to aid the fight against Covid-19. The 1Health.io platform has been adopted by Vitagene to facilitate the adherence to the requirements by the FDA for assessment of symptoms, telehealth and electronic tracking. This at-home test kit eliminates the need for patients to go to a clinic or increase the risk by going to a clinical setting.

United Imaging has announced that the first set of 12 mobile digital radiography (DR) systems arrived in Ukraine and will be installed in 11 hospitals in 9 cities to treat Covid-19 patients. The uDR 370i is equipped with a remote vision and control feature that offers better protection to the healthcare provider. The healthcare provider can monitor patients, preview images and adjust exposure at 33ft using a remote tablet, which reduces the chances of cross-infection between patients and physicians.

Aidoc has announced that the FDA has approved the use of its cleared AI algorithms that are meant for adjunctive use in identifying the findings related to Covid-19. The algorithm identifies and prioritises the incidental CT findings related to Covid-19 in any CT study that includes part of the lung or the entire lung. These findings are expected to manage the adverse effects of Covid-19 with the help of adjunctive information.

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