Ellume CEO Ponders Future Of Company’s Rapid COVID-19 Antigen Test
The developer of the at-home over-the-counter antigen test — the first of its kind to get an emergency use authorization from the FDA – received more than $200m from the government to manufacture in the US. So what’s next for Ellume? In this Medtech Insight case study Q&A, the Australian company’s CEO, Sean Parson, explains.
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Digital Health Roundup, March 2021: Record-Breaking Funding; Exec Chats With Medtronic, Edwards LifeSciences
In this new roundup feature focusing on the most notable developments in digital health, we pick the key news to date.
The government seems to be betting the company’s over-the-counter at-home antigen diagnostic test will be a game changer in stopping the spread of the coronavirus.
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.