Hello everyone,
I was looking at the Infection Prevention and Control Conference which was held at the National Conference Centre in Birmingham in April this year, and I have discovered a rival medical device; MeMed BV.
https://www.me-med.com/memed-bv/
MeMed BV is a direct competitor of FebriDx, and is FDA approved.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210254
In my personal opinion, the market opportunity for FebriDx has come and gone. So, what has gone wrong with FebriDx? How come MeMed BV was approved in just 7 months, and not FebriDx? I'd like to point out that both companies had to go through with the FDA approval process whilst new Covid-19 strains were emerging. One company accomplished to provide the meaningful data for the emerging new strains, and Lumos Diagnostics could not.
In the most recent quarterly report, Lumos announced that they were expecting to hear from the FDA about their decision on ViraDx in the coming months. Considering the financial trouble Lumos Diagnostics is in, another FDA rejection could be the end of Lumos.
Cheers.
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