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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
The SleepHub device works by playing scientifically formulated sounds through high- quality speakers, using specific beats and pulses to help modulate sleep patterns and emulate brain waves produced during sleep. Read More
The agency is not currently recommending that any STAR implants be removed, saying it is still appropriate for certain patients, such as older patients who are less active. Read More
The test runs on the common cobas 6800/8800 Systems and features a pre-optimized assay design, ready-to-use cassettes and pre-defined software parameters. Read More
The transaction is anticipated to finalize in the second quarter of the year, after which GenMark will continue to operate at its Carlsbad headquarters. 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
Users running the test should keep an eye out for unexpected clusters of positive Flu B results, which may indicate a tube leak, and repeat tests when two or three analytes are positive, as different results on the repeat test could indicate abnormal PCR cycling. Read More
The FDA issued an alert about thermal imaging systems intended to measure human body temperature because improper use of these systems may provide inaccurate temperature readings. Read More
A panel of the FDA’s Medical Devices Advisory Committee will meet virtually on April 6 to consider a premarket approval application for the TransMedics Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation of donor hearts intended for a transplant recipient. Read More