FDA
The stock took a tumble in October following the letter.
The news comes about a week after AppliedVR announced it raised $36 million in Series B funding.
Ellume began recalling the tests last month for giving false positive results.
Also, a Māori public health organisation develops a new tool to bring timely COVID-19-related information to Māori people.
The system uses virtual reality and an AI-backed tool.
The FDA said negative test results don’t appear to be affected.
The company landed a 510(k) for its single-source digital X-ray Nanox.ARC, and said more clearances are in the pipeline.
The Oxehealth Vital Signs system is installed in a patient's hospital room, where it can spot-measure pulse, heart, respiratory and breathing rates with no physical contact.
According to FDA documents, the test is intended to help stop the spread of COVID-19 among Amazon employees.
Also: Dexcom promotes Jereme Sylvain to EVP and CFO; Amalgam Rx snags CMS' Jennifer Main as COO and CFO.