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The analyzer can perform up to 870 tests per hour and run Roche’s full offering of diagnostic tests for infectious diseases, oncology and cardiology. Read More
With the agency’s first full approval for a COVID-19 diagnostic, tests of the same type may now go through its 510(k) pathway for potential clearance. Read More
The software produces a “likelihood of malignancy” finding that aligns with the American College of Radiology’s BI-RADS rating scale and Europe’s five-point rating system. Read More
It is made of nontapered metal-alloy and polymer that helps it better handle tough calcium and plaque found in late-stage peripheral artery disease and critical limb ischemia patients. Read More
There are so many COVID-19 tests on the market that one of the conditions for granting an Emergency Use Authorization — that there are no such products available — no longer applies. Read More
Pelican said that the test has high sensitivity in both symptomatic and asymptomatic patients and is able to detect known new viral variants as well. Read More